StemCell Therapy

RPMGlobal is celebrating the longevity of one of the mining industrys most trusted financial budgeting tools, XERAS, which turns 30 this month.

XERAS was first introduced to the mining industry in 1990 in an English desktop format, and within a year or two, had half a dozen users, according to RPM.

RPMGlobal has transformed the XERAS desktop product into a corporate enterprise solution, XERAS Enterprise, which, it says, is regarded as the budgeting solution of choice for many of the worlds top tier mining companies around the globe.

Now operating off a server-orientated database, XERAS Enterprise provides standardised, integrated budgets within a single environment, which enables users across all levels of the organisation to make informed financial decisions.

XERAS Enterprises zero-based budgeting approach delivers true cost control, transparency and financial agility to the budgeting and forecasting process.

Reflecting on 30 years of continuous product investment, RPMGlobal Chief Executive Officer, Richard Mathews, attributed the softwares success to constantly listening, and acting upon, customers evolving needs and challenges.

The uptake of XERAS Enterprise over the years is a testament to the companys commitment to fostering collaborative partnerships with our customers that places their needs at the front and centre of our product innovation strategy, he said.

According Mr Mathews, staying on top of evolving market trends is critical to remaining at the forefront of change.

At RPMGlobal, we are focused on keeping pace with the trends that are shaping the industry, like remote and cloud computing are currently, he said.

When XERAS was first created, for example, most mining operations were run as individual businesses. But that has changed over time.

As organisations have assimilated into larger, multi-site operations, the focus has turned to consistent corporate level solutions and XERAS Enterprise is a key offering in our integrated enterprise suite of products.

RPMGlobals innovative capabilities and ingrained knowledge of the end-to-end mining value chain have helped underpin the continuous improvement process that has led to the re-architecture of XERAS Enterprise throughout its 30-year evolution, it said.

For example, XERAS Enterprise can be integrated into any Enterprise Resource Planning system to deliver a live, zero-based forecasting environment, the company says. This significantly reduces the time it takes to generate budgets and forecasts, delivering companies an accurate financial position at any given time.

Last year marked one of the biggest re-architectural advances for the XERAS products in years with the introduction of XERAS Enterprise 3.0. This release included an updated user experience, improved database technology and enhanced enterprise capabilities.

Mathews said the company remained proud of the continued modernisation of the financial modelling software, which has helped ensure its longevity in the market.

XERAS Enterprise is a true 21st century software offering that provides trust in the numbers by standardising processes and removing manual data entry, while also allowing for agility and scalability that isnt available in any other system, he said.

Future step-changes in the offering will continue to be driven by customer engagement which involves understanding the clients usage and requirements and finding solutions that can best fulfil those needs.

The rest is here:
RPMGlobal looks back on 30 years of XERAS mining software - International Mining

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Although the latest figures show that the growth of life expectancy is slowing, women are living longer than ever. That is, of course, a great thing. But what are the implications of womens health and longevity when it comes to planning for retirement?

The latest Office for National Statistics (ONS) figures show that the average life expectancy for women is 83.1 years. This is undoubtedly positive in terms of enjoying life, friends and family, but it also means our pensions need to last longer.

But research shows that women typically retire with pensions worth just a fraction of mens. The reasons are, of course, varied, but it often comes down to issues like maternity leave, career breaks to care for family and being in lower paid jobs to start with.

But regardless of the whys and wherefores, the effect on our finances can be detrimental to say the least.

Talking about the link between womens health and financial outlook, Sharon Bonfield, Commercial Research Specialist at St Jamess Place Wealth Management, says:

Women typically live longer than men and may have a smaller pension pot, they need to plan accordingly to make their money last. While longevity sounds like a blessing, we wouldnt want to be unwell and struggling financially during our later-life years. But many women run the risk that this will be their future. A 40-year-old woman has a one in four chance of living to age 96, and a one in ten chance of living to 100.

Women not only need their pensions to last longer, they also generally have smaller pension pots to use during these extra years of life. We already know that women typically retire with one-fifth of the pension wealth of men. New analysis from the Centre for Economics and Business Research found that, when life expectancy is taken into account, the gender pensions gap could be as much as 108,130 for single women, and 186,120 for women who are married or in a relationship.

What you need depends on your lifestyle. To get an idea of whats enough, the Retirement Living Standards were developed. Based on independent research by Loughborough University, the standards suggest the amount we might need based on levels of comfort. The figures below are for singles not in a relationship.

Retirement Living Standards suggests singles will need at least 10,200 a year to live on. If they live in London, this goes up to 12,400.

This should work out enough to cover household bills, including DIY and maintenance. It also allows for a modest weekly shop (38), holidaying in the UK and enough for clothes, shoes and gifts. Crucially, it doesnt include maintaining a car, which for many singles can be a necessity.

The forecast here is 20,200 per year, or 24,100 in London. This allows for an increased budget in all areas and includes two weeks worth of European holidays. It also includes a 3-year-old car.

To live comfortably, the estimate is 33,000, going up to 36,300 in London. This level of annual income provides much greater freedom and a lot more comfort. It allows for a new kitchen and bathroom every 10-15 years and 3 weeks in Europe. Theres also enough for a newer car which can be replaced every five years.

If these figures have left you feeling a little discouraged, dont fret. There are things you can do right now to ensure a stress-free retirement. Sharon Bonfield offers this reassurance:

Luckily, there are things all women can do to increase your chances of a financially secure life, however long you live. If you do nothing else, have a think about what you want your future to look like. Do an appraisal of all your long-term savings plans, rounding up any small savings pots you may have forgotten about over time. Sit down and have a chat with a financial adviser to see how things are actually looking for your retirement years.

The most important thing is to not bury your head in the sand. After all, womens health and longevity should always be viewed positively rather than as a financial albatross.

The first step is to do your homework, which could mean getting to grips with understanding how pensions work in the first place and what you might already have. And as Sharon advises, think about what you want your future to look like. For example, have you considered early retirement?

Finally, professional help is always a wise investment, but its important to seek the right help. Our guide can point you in the right direction when it comes to choosing a financial advisor.

If youre looking for more ways to make your money work for you, why not sign up for MyWalletHeros email newsletter? Youll receive our teams top money-saving tips, lifestyle hacks and handy personal finance must-knows delivered straight to your inbox

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ORANGE, CA / ACCESSWIRE / November 9, 2020 / Just a few years ago Chris Long was broken.

He had just endured one of the most difficult seasons of his life and was battling intense anxiety and depression. He felt completely lost, but he was determined to not give up. In his darkest hour, Chris tapped into an inner strength he'd forgotten he had.

Born and raised in Orange, California, Chris was the son of two hardworking and successful parents. He is no stranger to adversity, tragedy, and loss.At just 6 years old, Chris lost his half brother in a tragic motorcycle accident, leaving him an only child. This event not only shifted the dynamics of his family, but also increased the pressure he felt to make his parents proud. He grew up playing any sport he could and soon realized a passion and affinity for football. He captained the Santa Margarita football team to a CIF state victory and went on to play football at the University of San Diego, where he received numerous awards, played in and or started every single game as a USD Torero, and was nominated to the Academic-All-American award multiple times as a result of his in-season GPAs. Although he'd obtained his degree in Business, Chris couldn't shake his love for fitness and the science behind motivating people to be their best. He spent the next 15 years working in the corporate fitness industry for 24 Hour Fitness, Equinox, Nike, and Velocity.

Still, Chris felt as though he was missing something. When layoffs in the big box gym industry took place in 2015, Chris was sent home with his final check from the company that he was proud to work for and treated as if it were his own, often investing his own finances to pay for certifications for his fellow employees.

Chris Long turns it on when the pressure is on and he definitely did at this point. Left unemployed, he decided to pursue his lifelong dream of opening a fitness and training studio. He opened the doors of Longevity soon thereafter. Longevity has had great success and even despite an early stage growth tactic that Chris rolled the dice on, the Longevity brand has never been stronger and has enriched the lives of so many. Working with both young athletes, and adults, to date, Chris has trained 80+ young athletes to succeed in collegiate athletics and has also helped 13 people lose over 100 lbs through his program. Chris has created and sustained strong relationships with a few of the athletes that he trained early on who he plans to make ambassadors once they graduate in order to scale Longevity in the future.

Story continues

"I run a tight ship," says Long, "Our expectations inspire people to level up in all aspects of their life in order to create habits that stick. We use a formula that sets people up for success. We provide the tools and the platform to improve their life and performance. This builds self confidence, on the path towards fulfilling one's true potential."

Chris keeps five key components of health in mind when working with each individual: Mindset, Nutrition, Sleep, Training, and Recovery.

"We ask that each member and client gives their 110% because we are always going to give the same in return!"

Chris has had both extreme success and some very difficult lessons. Unfortunately, most people don't share the difficulty involved with starting a business. While start-ups are often glamorized and praised for their success, Chris shares that there is a rougher side to entrepreneurship.

"It is lonely and there are sleepless nights, overdue bills at times. I would deal with debilitating anxiety leaving me reeling."

It was at this breaking point that Chris realized he needed to alter his mindset and seek support if he wanted to see his business succeed. He knew he needed some guidance because he had plateaued a bit and began sputtering as he was trying to get his company off of the ground.

He knew he had something special with Longevity and he knew he had all the talent in the world but he needed confirmation from someone he respected in the sports industry, maybe some words of affirmation. Chris then turned to a close family friend Leigh Steinberg of Steinberg Sports and Entertainment and asked for an hour of his time. Leigh, being his generous self, gave Chris his entire afternoon. Chris walked out knowing what he wanted as Leigh gave Chris confirmation that he has all it takes to accomplish anything. Chris and Leigh discussed strategy and alignment, the blocking and tackling of business. The meeting was extremely productive and Chris then reached out to Mr. David Metzler who is the CEO of Sports One Marketing, Warren Moon's marketing agency. David ran Leigh Steinberg's company for several years and represented some of the world's greatest athletes.

Simultaneously, Chris began to prioritize his health and self-love as his number one focus.

"If we don't have our health, we have nothing."

Chris endured quite a bit of pain early on in his business venture and that came as a result of hard life lessons, but he pulled himself up by his bootstraps, and asked for help from a world renowned mentor. This help came in the form of David Meltzer, his business coach and mentor. Metlzer has worked with Chris to create a clear vision for his life and his business. He taught him the value of radical humility and the importance of shining light in an otherwise dark world.

"Trauma corrodes our personal light, we have to work through that trauma before we can shine," says Chris. "Sometimes we simply need that one guy to believe in us. For me that was Coach D (as I call him). From our first conversation David helped me regain my positive spirit and loving, welcoming nature."

Long claims after a divorce rocked his world, he had trouble viewing the world in a positive light. Meltzer was able to refocus Chris and his framework leading to helping him view the world through a lens of gratitude every single day no matter what the circumstance. Chris has always possessed discipline but he worked on building a routine where he practices ending fear every single morning at 3:45 am during his morning meditation prior to seeing his first clients of the day at 4:45 am.

Armed with renewed confidence, Chris sought additional support for his business and it couldn't have come at a better time. When he needed more coaches at Longevity, he turned to one of the best coaches he knew and had the privilege to play for, Coach John Rodriguez, his old football coach at Santa Margarita that he played for between 1993-1997. Chris counts himself incredibly blessed to have been able to provide value to the same man that had poured into him all those years ago.

"Coach J-Rod is like a big brother to me. He mentored me early on in my life and I have always wanted to find a way to give back to those who have helped me throughout the years, there is nobody more deserving of an opportunity to grow a startup to its potential than Coach J-Rod."

Within a few months, Chris was ready to bring on an additional business advisor, Robert Toler. Robert played football at the University of Colorado and is a star athlete. The apple doesn't fall far from the tree either, Robert's youngest daughter, Saleh, is a track athlete at Los ALamitos High school, his eldest daughter ran and coached track in college, and his son Titus, who was highly recruited in high school out of St John Bosco, is a defensive back at the University of Wisconsin.

As Chris puts it, "Robert has the skillset to do pretty much anything with this company. We are both in similar stages in our lives and both strong in our faith. The day he walked into my facility, I instantly knew we would work together. I never wanted to grow this on my own. My wife started training his daughter and it just seemed right. We met several times and I talked about the vision I have had from day 1 which was to scale the business."

Chris already respected Robert, as his longtime teammate and ex NFL Texas Texan Jon Minardi played in high school with him. Robert brought innovative business strategy and growth development structural techniques to Longevity.

Chris states, "Robert is a very organized person. I am a very passionate people' person. That combo is so synergistic and pivotal to the growth of Longevity. I needed someone with thick skin and who I know would not take shortcuts."

Chris also works with a trainer himself to help him with his own athleticism and flexibility, a professional dancer named Sarah Gertler. She has also played a role in the success of Longevity.

Finally, Chris' wife, Lety Long, has proven to be a pivotal source of support for him during his darkest hours. Her positivity and wisdom encouraged him to persevere through the highs and lows of owning a business.

"Lety and I have a special relationship, I respect her more than any human being on the planet. There is just so much goodness that comes from Lety, and she has helped me build this company from the ground up," says Chris.

Lety coaches at Longevity part time outside of her regular career as a 7-8th grade special needs teacher at Kraemer Middle School.

Chris credits each of these unique individual's support and impact as the key component to the company elevating. Longevity's success through a season in which many other businesses were forced to close their doors has proven that one man is only capable of so much, but when you have a team of great leaders, amazing things can happen.

Chris is so very grateful for his members as they invest in themselves and work hard to better themselves by following the Longevity formula.

"Without them, there is no Longevity. These members have become family to me, it is pretty special."

"The past five years have flown by,'' Chris says.

When Chris Long started his business, he was a broken man. But through the support of those around him and his quest for self-love, he has conquered the impossible. Today, Chris feels fortunate for the years of suffering he endured, as they served to instill in him a radical humility and allowed him to see the world, and those around him, with renewed gratitude.

Chris shares the mantra that carried him through that difficult season, and now provides daily inspiration, "Live with radical humility, learn with authentic grace, and lead with extreme gratitude."

Chris is dedicated to bringing this same vision to the lives of others through personal and group training/coaching and his new book, The Longevity Redemption, available for pre-order. The book provides a first hand look into the tools Chris utilized to overcome depression and live into his full potential. Over the last few years, Chris has regained his confidence and learned to love himself again, and this is the same gift he strives to bring to each of his clients and readers.

Chris concludes, "As a coach, it is my mission to give people the confidence to believe in themselves. Once you have that confidence, you will do what you can do. You can do what you must do."

Contact Name: Chris LongBusiness Name: Longevity Sport and FitnessAddress: 966 N. Elm St. Orange, CA 92867Phone Number: (949) 350-2077Website Link: https://www.cplongevity.com/Send Email

SOURCE: Chris Long

View source version on accesswire.com: https://www.accesswire.com/615321/Chris-Long-Entrepreneur-Athlete-Coach-and-Author-Shares-His-Story-of-Adversity-and-the-Resilience-and-Support-That-Unlocked-His-Full-Potential

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Chris Long, Entrepreneur, Athlete, Coach, and Author, Shares His Story of Adversity, and the Resilience and Support That Unlocked His Full Potential -...

A self-described "misunderstood but sassy girl just tryin' to get some fish, Katharine the great white shark has resurfaced after more than a year. What was she doing? Well, just tryin to get some fish.

I mean. I was chasing a fish, but Ill roll with it. #WhatHeSaid https://t.co/NVoXsmQPi9

With more than 64,000 followers on Twitter, Katharine qualifies as an A-lister in the white shark community so obviously, she doesnt run her own social media account. She has people for that.

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Rob Landers is a journalist and actor who runs the account on behalf of OCEARCH, a nonprofit data collection organization that among other things tracks a number of white sharks around the world. White sharks are especially notorious for going radio silent (the radio being a SPOT-tag attached to their dorsal fin), and Katharine was last seen in May 2019.

According to the OSEARCH online tracking map, the 2,300-pound young adult popped up on their radar on Oct. 30 at 8:27 p.m. in the Atlantic Ocean, east of Virginia, after last being spotted near South Carolina.

America is changing faster than ever! Add Changing America to your Facebook or Twitter feed to stay on top of the news.

OCEARCH first tagged Katharine off the coast of Massachusettsin 2013 and has been following her ever since, setting a record for the longevity of her transmitter, Bryan Franks of Jacksonville University said on Facebook.

She was named for Katharine Lee Bates, a Cape Cod native and songwriter who wrote "America the Beautiful, and fans noted that she resurfaced just in time for the presidential elections, with the tweet "Miss Me?"

Safe to come up again? Yall are having a crazy week up there. #sharkgirl #sharkworld

It's been a pretty good year for Atlantic white sharks, all things considered, and a record number were recently tagged off the coast of southern California. Still, they are considered a vulnerable species, according to the World Wildlife Fund, thanks to years of human hunting and accidents. The world's largest known predatory fish often concentrate in warm waters near coasts, where there is an abundance of fish and marine mammals for them to prey on, making them susceptible to human interaction.

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Katharine the great white shark resurfaces off East Coast | TheHill - The Hill

Stem cells are biological cells which have the ability to distinguish into specialized cells, which are capable of cell division through mitosis. Amniotic fluid stem cells are a collective mixture of stem cells obtained from amniotic tissues and fluid. Amniotic fluid is clear, slightly yellowish liquid which surrounds the fetus during pregnancy and is discarded as medical waste during caesarean section deliveries. Amniotic fluid is a source of valuable biological material which includes stem cells which can be potentially used in cell therapy and regenerative therapies. Amniotic fluid stem cells can be developed into a different type of tissues such as cartilage, skin, cardiac nerves, bone, and muscles. Amniotic fluid stem cells are able to find the damaged joint caused by rheumatoid arthritis and differentiate tissues which are damaged.

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Medical conditions where no drug is able to lessen the symptoms and begin the healing process are the major target for amniotic fluid stem cell therapy. Amniotic fluid stem cells therapy is a solution to those patients who do not want to undergo surgery. Amniotic fluid has a high concentration of stem cells, cytokines, proteins and other important components. Amniotic fluid stem cell therapy is safe and effective treatment which contain growth factor helps to stimulate tissue growth, naturally reduce inflammation. Amniotic fluid also contains hyaluronic acid which acts as a lubricant and promotes cartilage growth.

With increasing technological advancement in the healthcare, amniotic fluid stem cell therapy has more advantage over the other therapy. Amniotic fluid stem cell therapy eliminates the chances of surgery and organs are regenerated, without causing any damage. These are some of the factors driving the growth of amniotic fluid stem cell therapy market over the forecast period. Increasing prevalence of chronic diseases which can be treated with the amniotic fluid stem cell therapy propel the market growth for amniotic fluid stem cell therapy, globally. Increasing funding by the government in research and development of stem cell therapy may drive the amniotic fluid stem cell therapy market growth. But, high procedure cost, difficulties in collecting the amniotic fluid and lack of reimbursement policies hinder the growth of amniotic fluid stem cell therapy market.

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The global amniotic fluid stem cell therapy market is segmented on basis of treatment, application, end user and geography:

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Rapid technological advancement in healthcare, and favorable results of the amniotic fluid stem cells therapy will increase the market for amniotic fluid stem cell therapy over the forecast period. Increasing public-private investment for stem cells in managing disease and improving healthcare infrastructure are expected to propel the growth of the amniotic fluid stem cell therapy market.

However, on the basis of geography, global Amniotic Fluid Stem Cell Therapy Market is segmented into six key regionsviz. North America, Latin America, Europe, Asia Pacific Excluding China, China and Middle East & Africa. North America captured the largest shares in global Amniotic Fluid Stem Cell Therapy Market and is projected to continue over the forecast period owing to technological advancement in the healthcare and growing awareness among the population towards the new research and development in the stem cell therapy. Europe is expected to account for the second largest revenue share in the amniotic fluid stem cell therapy market. The Asia Pacific is anticipated to have rapid growth in near future owing to increasing healthcare set up and improving healthcare expenditure. Latin America and the Middle East and Africa account for slow growth in the market of amniotic fluid stem cell therapy due to lack of medical facilities and technical knowledge.

Some of the key players operating in global amniotic fluid stem cell therapy market are Stem Shot, Provia Laboratories LLC, Thermo Fisher Scientific Inc. Mesoblast Ltd., Roslin Cells, Regeneus Ltd. etc. among others.

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Persistence Market Research (PMR) is a third-platform research firm. Our research model is a unique collaboration of data analytics andmarket research methodologyto help businesses achieve optimal performance.

To support companies in overcoming complex business challenges, we follow a multi-disciplinary approach. At PMR, we unite various data streams from multi-dimensional sources. By deploying real-time data collection, big data, and customer experience analytics, we deliver business intelligence for organizations of all sizes.

Our client success stories feature a range of clients from Fortune 500 companies to fast-growing startups. PMRs collaborative environment is committed to building industry-specific solutions by transforming data from multiple streams into a strategic asset.

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Naved BegPersistence Market ResearchAddress 305 Broadway, 7th Floor New York City,NY 10007 United StatesU.S. Ph. +1-646-568-7751USA-Canada Toll-free +1 800-961-0353Sales[emailprotected]Websitehttps://www.persistencemarketresearch.com

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The Amniotic Fluid Stem Cell Therapy market to be in conjunction to growth from 2018 to 2026 - PRnews Leader

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Persistence Market Research (PMR) has published a new research report on canine stem cell therapy. The report has been titled, Canine Stem Cell Therapy Market: Global Industry Analysis 2016 and Forecast 20172026.Veterinary research has been used in regenerative and adult stem cell therapy andhas gained significant traction over the last decade.

Canine stem cell therapy products are identified to have gained prominence over the past five years, and according to the aforementioned research report, the market for canine stem cell therapy will expand at a moderate pace over the next few years.

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Though all animal stem cells are not approved by FDA, veterinary stem-cell manufacturers and university researchers have been adopting various strategies in order to meet regulatory approvals, and streamline and expedite the review-and-approval process. The vendors in the market are incessantly concentrating on research and development to come up with advanced therapy, in addition to acquiring patents.

In September 2017, VetStem Biopharma, Inc. received European patent granted to the University of Pittsburgh and VetStem received full license of the patent then. This patent will eventually provide the coverage for the ongoing commercial and product development programs of VetStem and might be also available for licensing to other companies who are rather interested in this field.

The other companies operating in the global market for canine stem cell therapy are VETherapy Corporation, Aratana Therapeutics, Inc., Regeneus Ltd, Magellan Stem Cells, Animal Cell Therapies, Inc., and Medrego, among others.

According to the Persistence Market Research report, the globalcanine stem cell therapy marketis expected to witness a CAGR of 4.2% during the forecast period 2017-2026. In 2017, the market was valued at US$ 151.4 Mn and is expected to rise to a valuation of US$ 218.2 Mn by the end of 2026.

Burgeoning Prevalence of Chronic Diseases in Dogs to Benefit Market

Adipose Stem Cells (ASCs) are the most prevalent and in-demand adult stem cells owing to their safety profile, ease of harvest, and use and the ability to distinguish into multiple cell lineages. Most early clinical research is focused on adipose stem cells to treat various chronic diseases such as arthritis, tendonitis, lameness, and atopic dermatitis in dogs.

A large area of focus in veterinary medicine is treatment of osteoarthritis in dogs, which becomes more prevalent with age. Globally, more than 20% dogs are suffering from arthritis, which is a common form of canine joint and musculoskeletal disease. Out of those 20%, merely 5% seem to receive the treatment.

However, elbow dysplasia in canine registered a prevalence rate of 64%, converting it into an alarming disease condition to be treated on priority. Thereby, with the growing chronic disorders in canine, the demand for stem cell therapy is increasing at a significant pace.

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Expensive Nature of Therapy to Obstruct Growth Trajectory

Expensive nature and limited access to canine stem cell therapy has demonstrated to be a chief hindrance forestalling its widespread adoption. The average tier II and tier III veterinary hospitals lack the facilities and expertise to perform stem cell procedures, which necessitates the referral to a specialty vet hospital with expertise veterinarians.

A trained veterinary physician charges high treatment cost associated with stem cell therapy for dogs. Generally, dog owners have pet insurance that typically covers maximum cost associated with steam cell therapy to treat the initial injury but for the succeeding measures in case of retreatment, the costs are not covered under the pet insurance. The stem cell therapy is thus cost-prohibitive for a large number of pet owners, which highlights a major restraint to the market growth. Stem cell therapy is still in its developmental stage and a positive growth outcome for the market cannot be confirmed yet.

Explore Extensive Coverage of PMR`sLife Sciences & Transformational HealthLandscape

Persistence Market Research (PMR) is a third-platform research firm. Our research model is a unique collaboration of data analytics and market research methodology to help businesses achieve optimal performance.

To support companies in overcoming complex business challenges, we follow a multi-disciplinary approach. At PMR, we unite various data streams from multi-dimensional sources. By deploying real-time data collection, big data, and customer experience analytics, we deliver business intelligence for organizations of all sizes.

Our client success stories feature a range of clients from Fortune 500 companies to fast-growing startups. PMRs collaborative environment is committed to building industry-specific solutions by transforming data from multiple streams into a strategic asset.

Contact us:

Ashish KoltePersistence Market ResearchAddress 305 Broadway, 7th FloorNew York City,NY 10007 United StatesU.S. Ph. +1-646-568-7751USA-Canada Toll-free +1 800-961-0353Sales[emailprotected]Website https://www.persistencemarketresearch.com

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The Canine Stem Cell Therapy Market To Move Away From Insipidness, Reach US$ 218.2 Mn - PRnews Leader

The global stem cell therapy market is estimated to surpass $18,391.9 million by 2027, exhibiting a CAGR of 10.0% from 2020 to 2027.

The report aims to offer a clear picture of the current scenario and future growth of the global Stem Cell Therapy market. The report provides scrupulous analysis of global market by thoroughly reviewing several factors of the market such as vital segments, regional market condition, market dynamics, investment suitability, and key players operating in the market. Besides, the report delivers sharp insights into present and forthcoming trends & developments in the global market.

The report articulates the key opportunities and factors propelling the global Stem Cell Therapy market growth. Also, threats and limitations that have the possibility to hamper the market growth are outlined in the report. Further, Porters five forces analysis that explains the bargaining power of suppliers and consumers, competitive landscape, and development of substitutes in the market is also sketched in the report.

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The report reveals various statistics such as predicted market size and forecast by analyzing the major factors and by assessing each segment of the global Stem Cell Therapy market. Regional market analysis of these segments is also provided in the report. The report segments the global market into four main regions including Asia-Pacific, Europe, North America, and LAMEA. Moreover, these regions are sub-divided to offer an exhaustive landscape of the Stem Cell Therapy market across key countries in respective regions. Furthermore, the report divulges some of the latest advances, trends, and upcoming opportunities in every region.

Furthermore, the report profiles top players active in the global Stem Cell Therapy market. A comprehensive summary of 10 foremost players operating in the global market is delivered in the report to comprehend their position and footmark in the industry. The report highlights various data points such as short summary of the company, companys financial status and proceeds, chief company executives, key business strategies executed by company, initiatives undertaken & advanced developments by the company to thrust their position and grasp a significant position in the market.

RESEARCH METHODOLOGY

The research report is formed by collating different statistics and information concerning the Stem Cell Therapy market. Long hours of deliberations and interviews have been performed with a group of investors and stakeholders, including upstream and downstream members. Primary research is the main part of the research efforts; however, it is reasonably supported by all-encompassing secondary research. Numerous product type literatures, company annual reports, market publications, and other such relevant documents of the leading market players have been studied, for better & broader understanding of market penetration. Furthermore, medical journals, trustworthy industry newsletters, government websites, and trade associations publications have also been evaluated for extracting vital industry insights.

Connect with Our Analyst to Contextualize Our Insights for Your Business:https://www.researchdive.com/connect-to-analyst/527

KEY MARKET BENEFITS

KEY MARKET SEGMENTS

The global Stem Cell Therapy market is segmented on the basis of the following:

Global Stem Cell Therapy Market By Product Type:

Global Stem Cell Therapy Market By Applications:

Global Stem Cell Therapy Market By Regions:

Top Leading key players stated in Global Stem Cell Therapy Market report are:

Astellas Pharma Inc., Capricor Therapeutics, Cellectis, Cellular Dynamics, Celyad, CESCA Therapeutic, DiscGenics, Gamida Cell, Mesoblast Ltd, Novadip Biosciences, OxStem.

The report also summarizes other important aspects including financial performance, product portfolio, SWOT analysis, and recent strategic moves and developments of the leading players.

Contact Us:

Mr. Abhishek PaliwalResearch Dive30 Wall St. 8th Floor, New YorkNY 10005 (P)+ 91 (788) 802-9103 (India)+1 (917) 444-1262 (US) TollFree : +1 -888-961-4454Email:[emailprotected]LinkedIn:https://www.linkedin.com/company/research-diveTwitter:https://twitter.com/ResearchDiveFacebook:https://www.facebook.com/Research-DiveBlog:https://www.researchdive.com/blogFollow us on:https://covid-19-market-insights.blogspot.com

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Latest Update 2020: Why Dynamics of Stem Cell Therapy Market Is Changing Drastically? What If History Is Any Guide? - Eurowire

The global stem cell therapy market is estimated to surpass $18,391.9 million by 2027, exhibiting a CAGR of 10.0% from 2020 to 2027.

The report aims to offer a clear picture of the current scenario and future growth of the global Stem Cell Therapy market. The report provides scrupulous analysis of global market by thoroughly reviewing several factors of the market such as vital segments, regional market condition, market dynamics, investment suitability, and key players operating in the market. Besides, the report delivers sharp insights into present and forthcoming trends & developments in the global market.

The report articulates the key opportunities and factors propelling the global Stem Cell Therapy market growth. Also, threats and limitations that have the possibility to hamper the market growth are outlined in the report. Further, Porters five forces analysis that explains the bargaining power of suppliers and consumers, competitive landscape, and development of substitutes in the market is also sketched in the report.

For More Detail Insights, Download Sample Copy of the Report at: https://www.researchdive.com/download-sample/527

The report reveals various statistics such as predicted market size and forecast by analyzing the major factors and by assessing each segment of the global Stem Cell Therapy market. Regional market analysis of these segments is also provided in the report. The report segments the global market into four main regions including Asia-Pacific, Europe, North America, and LAMEA. Moreover, these regions are sub-divided to offer an exhaustive landscape of the Stem Cell Therapy market across key countries in respective regions. Furthermore, the report divulges some of the latest advances, trends, and upcoming opportunities in every region.

Furthermore, the report profiles top players active in the global Stem Cell Therapy market. A comprehensive summary of 10 foremost players operating in the global market is delivered in the report to comprehend their position and footmark in the industry. The report highlights various data points such as short summary of the company, companys financial status and proceeds, chief company executives, key business strategies executed by company, initiatives undertaken & advanced developments by the company to thrust their position and grasp a significant position in the market.

RESEARCH METHODOLOGY

The research report is formed by collating different statistics and information concerning the Stem Cell Therapy market. Long hours of deliberations and interviews have been performed with a group of investors and stakeholders, including upstream and downstream members. Primary research is the main part of the research efforts; however, it is reasonably supported by all-encompassing secondary research. Numerous product type literatures, company annual reports, market publications, and other such relevant documents of the leading market players have been studied, for better & broader understanding of market penetration. Furthermore, medical journals, trustworthy industry newsletters, government websites, and trade associations publications have also been evaluated for extracting vital industry insights.

Connect with Our Analyst to Contextualize Our Insights for Your Business:https://www.researchdive.com/connect-to-analyst/527

KEY MARKET BENEFITS

KEY MARKET SEGMENTS

The global Stem Cell Therapy market is segmented on the basis of the following:

Global Stem Cell Therapy Market By Product Type:

Global Stem Cell Therapy Market By Applications:

Global Stem Cell Therapy Market By Regions:

Top Leading key players stated in Global Stem Cell Therapy Market report are:

Astellas Pharma Inc., Capricor Therapeutics, Cellectis, Cellular Dynamics, Celyad, CESCA Therapeutic, DiscGenics, Gamida Cell, Mesoblast Ltd, Novadip Biosciences, OxStem.

The report also summarizes other important aspects including financial performance, product portfolio, SWOT analysis, and recent strategic moves and developments of the leading players.

Contact Us:

Mr. Abhishek PaliwalResearch Dive30 Wall St. 8th Floor, New YorkNY 10005 (P)+ 91 (788) 802-9103 (India)+1 (917) 444-1262 (US) TollFree : +1 -888-961-4454Email:[emailprotected]LinkedIn:https://www.linkedin.com/company/research-diveTwitter:https://twitter.com/ResearchDiveFacebook:https://www.facebook.com/Research-DiveBlog:https://www.researchdive.com/blogFollow us on:https://covid-19-market-insights.blogspot.com

The rest is here:
Trending News: Stem Cell Therapy Market Anticipated for Progressive CAGR Growth During 2020-2027 - The Think Curiouser

By The Acorn Staff | on November 05, 2020

Twenty years ago, when stem cell therapy was highly regulated in the United States and other countries, it was well underway in the Hadassah Hospital labs in Jerusalem.

Never would we have imagined that the U.S. expansion of one of the key clinical trials conducted in our labs in Israel would be later funded by Californias Stem Cell Institute.

In 2004, California had the foresight to advance this critical area of research with the passage of Prop. 71 in 2004.

Stem cells replace damaged or diseased tissue. In this way, treatments or cures for diseases like age-related macular degeneration, ALS, MS, Parkinsons, Alzheimers and diabetes could be a reality in the foreseeable future.

I come to this subject from a place of personal sorrow. I watched my father-in-law, Irv, suffer for 12 years with ALS, a man I loved as if he were my own father. He fought hard. He made every minute of his battle meaningful, to soak up as much life as he could until he couldnt.

Hadassah researchers conducted the worlds first clinical trial using the patients own bone marrow stem cells to treat ALS. Expanded stem cell trials are now taking place here in California to treat ALS.

The California Stem Cell Agencys ALS funding has awarded a total of $79 million in grants to understand ALS and then to translate those discoveries into treatments and therapies. Two have already reached the clinical trial phase.

A Phase 1 clinical trial at Cedars-Sinai was funded to investigate the safety and efficacy of ways in which surviving neurons can be protected in people with ALS.

The second, a Phase 3 clinical trial at Brainstorm Cell Therapeutics, first began in Israel. The approach is to use mesenchymal stem cells derived from bone marrow boosted with protective factors to support and protect the neurons of ALS patients.

Stacey DorenfeldAgoura Hills

Dorenfeld is the National State Advocacy co-chair and the Hadassah Southern California advocacy chair.

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Stem cells key to ALS therapy - Agoura Hills Acorn

Animal Stem Cell Therapy Market Overview

The Global Animal Stem Cell Therapy Market is showing positive signs of growth. With the current COVID-19 pandemic scenario, new business opportunities are sprouting in the market. Organizations must explore new markets to expand their business globally and locally. For getting a deeper understanding of the emerging trends, the Global Animal Stem Cell Therapy Market report showcases various factors that drive the economy worldwide. Moreover, the companies will get to know the market landscape for the next decade 2020-2027.

The Global Animal Stem Cell Therapy Market report has been uniquely designed to cater to the needs of the businesses of the 21st century. Going digital is the new normal. Moreover, companies can get to understand their strengths and weaknesses after assessing the market. The next decade is going to be ruled by customer-centric services. To align the business operations, the management team can utilize the actionable recommendations offered at the end of the Global Animal Stem Cell Therapy Market report. Factors that can lift or reduce the business are termed as the external factors that also govern the functioning of the market or industries as a whole.

Before designing the blueprint, every business group can go through the Global Animal Stem Cell Therapy Market report to understand the key business areas. For shaping a new business venture or expanding into a new market, every company must look into the opportunities and threats that are lurking in the current market. To make an efficient business plan, corporations need to understand the market dynamics that will shape the market in the forecast period (2020-2027).

Following key players have been profiled with the help of proven research methodologies:

Animal Stem Cell Therapy Market: Competitive Landscape

To get a head start in a new market, every enterprise needs to understand the competitive landscape and the basic rules that have kept the specific market afloat. The global Animal Stem Cell Therapy Market report unravels the secret ingredients used by competitors to meet the demands of their target audience. For specifically understanding the need to balance the capital invested with profits, organizations must use specific indicators. These indicators will not only help in pointing towards growth but also act as an alert to the upcoming threats in the near future. A proper business plan and approach can guarantee a smooth path ahead for every organization.

If the firms believe in offering a memorable experience to their prospective customers, the Global Animal Stem Cell Therapy Market report is going to be very useful. Facts and figures are churned into this investigative report to share the strengths and weaknesses of the company. With new technologies being introduced every day, many new entrants have started their business in the market. So, to understand their approach towards the market, the Global Animal Stem Cell Therapy Market report has a dedicated section. From the financial aspect to legal, the market report covers all the major things required to study the market and put the business plan in action. Not only this, the competitors added in the report can be altered as per the clients needs and expectations. Furthermore, the companies get a basic outline of moves, in the Global Animal Stem Cell Therapy Market report, that can push the business to emerald heights, both in terms of sales and customer generation for the estimated time frame (2020-2027).

Animal Stem Cell Therapy Market Segmentation:

The Animal Stem Cell Therapy Market has been examined into different global market segments such as type, applications, and global geographies. Each and every global market segment has been studied to get informative insights into various global regions.

Animal Stem Cell Therapy Market Segment by Type:

Animal Stem Cell Therapy Market Segment by Application:

Animal Stem Cell Therapy Market Segment by Global Presence:

North America Latin America Middle East Asia-Pacific Africa Europe

The report has been aggregated by using a couple of research methodologies such as primary and secondary research techniques. It helps in collecting informative pieces of professional information for deriving effective insights into the market. This informative report helps in making well informed and strategic decisions throughout the forecast period.

Animal Stem Cell Therapy Market: Scope of the Report

To properly get a deeper understanding of the Global Animal Stem Cell Therapy Market, this detailed report is the best choice for businesses. To boost the business along with gaining an edge over the competition, every enterprise needs to focus on the pain points of the market (under investigation). Our experienced professionals have collated facts and figures.

This in-depth analysis has revealed many fascinating facts for organizations. For smooth functioning, every business needs to be flexible towards the latest market trends. For this, the framework must be designed to adapt to the trends running at the moment. An end-to-end examination done on the target crowd helped in building the fundamental segment of the investigation, namely the external factors. These have a high tendency to push or pull the industries. Entire industries can either flourish or wipe out due to these uncontrollable factors. Global Animal Stem Cell Therapy market report shows the most affordable options for new as well as established business players to gain market share.

With the highly experienced and motivated team at your service, the team also provides the impact of major factors such as Porters five forces. In the Global Animal Stem Cell Therapy Market, every business runs on the image that is generated digitally in the current decade. Hence, companies need to understand the legal hurdles also. Moreover, with the in-depth study conducted across the various market verticals, it is crystal clear that stakeholders also play a significant role in running the business. Get all the details in the Global Animal Stem Cell Therapy Market report and understand your competitors.

Key questions answered through this analytical market research report include:

What are the latest trends, new patterns and technological advancements in the Animal Stem Cell Therapy Market? Which factors are influencing the Animal Stem Cell Therapy Market over the forecast period? What are the global challenges, threats and risks in the Animal Stem Cell Therapy Market? Which factors are propelling and restraining the Animal Stem Cell Therapy Market? What are the demanding global regions of the Animal Stem Cell Therapy Market? What will be the global market size over the coming future? What are the different effective business strategies followed by global companies?

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Animal Stem Cell Therapy Market Size, Drivers, Potential Growth Opportunities, Competitive Landscape, Trends And Forecast To 2027 - Eurowire

This article was originally published here

Sheng Wu Gong Cheng Xue Bao. 2020 Oct 25;36(10):1970-1978. doi: 10.13345/j.cjb.200216.

ABSTRACT

At present, SARS-CoV-2 is raging, and novel coronavirus pneumonia (COVID-19) has caused more than 35 million confirmed patients and more than 500 000 cases death, which seriously endanger human health, socioeconomic development, as well as global medical and public health systems. COVID-19 is highly contagious, has a long incubation period, and causes many death cases due to lack of effective specific treatment. Mesenchymal stem cells have powerful anti-inflammatory and immunoregulatory functions, and can effectively reduce the cytokine storm caused by coronavirus in patients, and improve the pulmonary fibrosis of patients, promote the repair of damaged lung tissue, and reduce the mortality. Currently, a number of related clinical trials of mesenchymal stem cell treatment of COVID-19 have been conducted, and have confirmed the safety and efficacy, suggesting a good clinical application prospect. While progress has been made in mesenchymal stem cell therapy for COVID-19, we should also catch sight of the problems and challenges faced by mesenchymal stem cell clinical trials under severe epidemic situation, including clinical trials design, stem cell quality management, and ethics in treatment. Only by paying attention to these can we guarantee the safe and effective development of mesenchymal stem cell clinical trials in the treatment of COVID-19.

PMID:33169563 | DOI:10.13345/j.cjb.200216

Original post:
Mesenchymal stem cells in the treatment of COVID-19-progress and challenges - DocWire News

This article was originally published here

Sheng Wu Gong Cheng Xue Bao. 2020 Oct 25;36(10):1979-1991. doi: 10.13345/j.cjb.200355.

ABSTRACT

Coronavirus disease 2019 (COVID-19) has spread widely on a large scale in the whole world at present, seriously endangering human health. There are still no effective and specific drugs, so it is urgent to find safe and effective therapeutic methods. Mesenchymal stem cells (MSCs) have many biological functions of powerful immunomodulation and tissue repair and regeneration. As a stem cell therapy, it has the potential to reduce the tissue injury and mortality in severe patients infected with novel coronavirus. At present, many research institutions in China and abroad have started a number of clinical research projects about MSCs in the treatment of COVID-19. In addition, those projects have initially confirmed the safety and effectiveness of this therapy. Therefore, this research field has been proved to have a very good clinical therapy prospect.

PMID:33169564 | DOI:10.13345/j.cjb.200355

See the original post:
Mesenchymal stem cells in therapy of coronavirus disease 2019 - a review - DocWire News

The Stem Cell Therapy Market study describes the current market size and market forecast, market prospects, main drivers and constraints, regulatory scenario, industry trend, PESTLE analysis, PORTER analysis, new product approvals / launch, promotion and marketing campaigns, pricing analysis , competitive environment to assist companies in decision-making. The data from the study is focused on current and historical market dynamics that assist in decisions related to investment.

Stem Cell Therapy offers fundamental industry overview representing market trends, company profiles, growth drivers, market scope and Stem Cell Therapy size estimation. The valuable Stem Cell Therapy industry insights, type, application, deployment status and research regions are studied. A thorough analysis of gross margin view, trade news, industry plans and policies, constraints are explained. A complete Stem Cell Therapy industry scenario is explained from 2014 to 2019 and forecast estimates are presented from 2020-2027. The productions, industry chain analysis, gross margin structure and deployment models are stated in detail. Top regions analysed in the report include North America, South America, Europe, Asia-Pacific, Middle East & Africa and the rest of the world. The Stem Cell Therapy industry presence and maturity analysis will lead to investment feasibility and development scope.

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Stem Cell Therapy Market Leading Players (2019-2027):

Celgene CorporationOsiris Therapeutics, Inc.Pharmicell Co., LtdMEDIPOST Co., Ltd.Promethera BiosciencesFibrocell Science, Inc.Holostem Terapie Avanzate S.r.l.Cytori TherapeuticsNuvasive, Inc.RTI Surgical, Inc.Anterogen Co., Ltd.RTI Surgical, Inc

Market Segment Analysis

By Types:

Adult Stem CellsHuman EmbryonicInduced Pluripotent Stem CellsVery Small Embryonic Like Stem Cells

By Applications:

Regenerative MedicineDrug Discovery and Development

By Region

North America

Europe

Asia-Pacific

LAMEA

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Stem Cell Therapy Industry Report addresses different regions like North America, Europe, Asia-Pacific, Middle East & Africa and Latin America. The production value, gross margin analysis, development trend, and Stem Cell Therapy market positioning is explained. The industrial chain study, potential buyers, distributors and traders details are explained. The challenges to the growth and market restraints are explained. The market maturity study, investment scope and gross margin study are profiled. The production process structure, market share, manufacturing cost and Stem Cell Therapy saturation analysis is covered. This will helps the industry aspirants to analysis growth feasibility and development plans.

A special highlight on cost structure, import-export scenario and sales channels of Stem Cell Therapy industry is presented. The benchmarking products, dynamic market changes, upstream raw material and downstream buyers analysis are presented. The business trends, key players analysis and product segment study are explained. The regional SWOT analysis, gross margin analysis, application analysis and industry barriers are explained. The value, volume and consumption from 2019-2027 is portrayed. All the essential details like pricing structure of raw materials, labour cost, sales channels and downstream buyers are presented.

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In the next segment, the forecast Stem Cell Therapy industry perspective is covered. Under forecast statistics, the market value, volume and consumption forecast from 2019-2027 is explained. Stem Cell Therapy regional analysis for major regions and countries in this region is stated. The study of new Stem Cell Therapy industry aspirants and analysts opinions for this industry is presented. The limitations to the industry growth, market risks, Stem Cell Therapy growth opportunities and market trends are viewed. The revenue, Stem Cell Therapy market status, past market performance and product details are presented.

Salient Features Of The Report:

The Stem Cell Therapy report serves as a vital guide in portraying present and forecast industry statistics and market size. The supply/ demand situation, gross margin view and competitive profile of top Stem Cell Therapy players are presented. The Stem Cell Therapy market breakdown by product, type, application and regions will provide sophisticated and precise analysis. Recent developments in Stem Cell Therapy industry, growth opportunities, constraints are studied completely. Also, new product launch events, mergers & acquisitions of Stem Cell Therapy, and industry plans and policies are covered.

The revenue estimates of Stem Cell Therapy market based on top industry players, their product type, applications and regions is studied. The cost structures, gross margin view, sales channel analysis and value chain is explained. In the next segment, the SWOT analysis of players, cost structures, traders, distributors and dealers are listed. The forecast study on Stem Cell Therapy industry will be useful for business plans and growth analysis.

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Global Stem Cell Therapy Market Growth Factor with Regional Forecast, Segmentation, Investment Opportunities, Industry Research and End User Analysis...

Adroit Market Research delivers well-researched industry-wide information on the Stem Cell Therapy market. It provides information on the markets essential aspects such as top participants, factors driving Stem Cell Therapy market growth, precise estimation of the Stem Cell Therapy market size, upcoming trends, changes in consumer behavioral pattern, markets competitive landscape, key market vendors, and other market features to gain an in-depth analysis of the market. Additionally, the report is a compilation of both qualitative and quantitative assessment by industry experts, as well as industry participants across the value chain. The report also focuses on the latest developments that can enhance the performance of various market segments.

This report strategically examines the micro-markets and sheds light on the impact of technology upgrades on the performance of the Stem Cell Therapy market. The report presents a broad assessment of the market and contains solicitous insights, historical data, and statistically supported and industry-validated market data. The report offers market projections with the help of appropriate assumptions and methodologies. The research report provides information as per the market segments such as geographies, products, technologies, applications, and industries.

A sample of report copy could be downloaded by visiting the site: https://www.adroitmarketresearch.com/contacts/request-sample/691?utm_source=PT

Competitive Landscape:The global Stem Cell Therapy market is highly consolidated due to the presence of a large number of companies across this industry. The report discusses the current market standing of these companies, their past performances, demand and supply graphs, production and consumption patterns, sales network, distribution channels, and growth opportunities in the market. Moreover, it highlights the strategic approaches of the key players towards expanding their product offerings and reinforcing their market presence.

The report analyzes the key elements such as demand, growth rate, cost, capacity utilization, import, margin, and production of the global market players. A number of the factors are considered to analyze the global Stem Cell Therapy Market. The global Stem Cell Therapy Market report demonstrates details of different sections and sub-sections of the global Stem Cell Therapy Market on the basis of topographical regions. The report provides a detailed analysis of the key elements such as developments, trends, projections, drivers, and market growth of the global Stem Cell Therapy Market. It also offers details of the factors directly impacting on the growth of the global Stem Cell Therapy Market. It covers the fundamental ideas related to the growth and the management of the global Stem Cell Therapy Market.

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Global Stem Cell Therapy market is segmented based by type, application and region.Based on Type, the market has been segmented into:

Based on cell source, the market has been segmented into,

Adipose Tissue-Derived Mesenchymal SCsBone Marrow-Derived Mesenchymal SCsEmbryonic SCsOther Sources

Based on Application, the market has been segmented into:

Based on therapeutic application, the market has been segmented into,

Musculoskeletal DisordersWounds & InjuriesCardiovascular DiseasesGastrointestinal DiseasesImmune System DiseasesOther Applications

Stem Cell Therapy Industry Report addresses different regions like North America, Europe, Asia-Pacific, Middle East & Africa and Latin America. The production value, gross margin analysis, development trend, and Stem Cell Therapy market positioning is explained. The industrial chain study, potential buyers, distributors and traders details are explained. The challenges to the growth and market restraints are explained. The market maturity study, investment scope and gross margin study are profiled. The production process structure, market share, manufacturing cost and Stem Cell Therapy saturation analysis is covered. This will helps the industry aspirants to analysis growth feasibility and development plans. A special highlight on cost structure, import-export scenario and sales channels of Stem Cell Therapy industry is presented. The benchmarking products, dynamic market changes, upstream raw material and downstream buyers analysis are presented. The business trends, key players analysis and product segment study are explained. The regional SWOT analysis, gross margin analysis, application analysis and industry barriers are explained. The value, volume and consumption from 2019-2024 is portrayed. All the essential details like pricing structure of raw materials, labour cost, sales channels and downstream buyers are presented.

Browse complete Stem Cell Therapy market report description and TOC @ https://www.adroitmarketresearch.com/industry-reports/stem-cell-therapy-market?utm_source=PT

Key Questions Answered in the Report:1.What is the size of the overall Stem Cell Therapy Market and its segments?2.What are the key segments and sub-segments in the market?3.What are the key drivers, restraints, opportunities, and challenges of the Stem Cell Therapy Market and how they are expected to impact the market?4.What are the attractive investment opportunities within the Market?5.What is the Stem Cell Therapy Market size at the regional and country-level?6.Who are the key market players and their key competitors?7.Market value- chain and key trends impacting every node with reference to companies8.What are the strategies for growth adopted by the key players in Stem Cell Therapy Market?9.How does a particular company rank against its competitors with respect to revenue, profit comparison, operational efficiency, cost competitiveness, and market capitalization?10.How financially strong are the key players in Stem Cell Therapy Market (revenue and profit margin, market capitalization, expenditure analysis, investment analysis)?11.What are the recent trends in Stem Cell Therapy Market? (M&A, partnerships, new product developments, expansions)

Table of ContentsChapter 1 Stem Cell Therapy Market OverviewChapter 2 Global Economic Impact on IndustryChapter 3 Global Market Competition by ManufacturersChapter 4 Global Production, Revenue (Value) by RegionChapter 5 Global Supply (Production), Consumption, Export, Import by RegionsChapter 6 Global Production, Revenue (Value), Price Trend by TypeChapter 7 Global Market Analysis by ApplicationChapter 8 Manufacturing Cost AnalysisChapter 9 Industrial Chain, Sourcing Strategy and Downstream BuyersChapter 10 Marketing Strategy Analysis, Distributors/TradersChapter 11 Market Effect Factors AnalysisChapter 12 Global Stem Cell Therapy Market Forecast

Adroit Market Research is an India-based business analytics and consulting company. Our target audience is a wide range of corporations, manufacturing companies, product/technology development institutions and industry associations that require understanding of a markets size, key trends, participants and future outlook of an industry. We intend to become our clients knowledge partner and provide them with valuable market insights to help create opportunities that increase their revenues. We follow a code Explore, Learn and Transform. At our core, we are curious people who love to identify and understand industry patterns, create an insightful study around our findings and churn out money-making roadmaps.

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Stem Cell Therapy Market 2020 Trends, Growth Insight, Share, Competitive Analysis, Statistics, Regional and Global Industry Forecast To 2025 - PRnews...

The globalCanine Stem Cell Therapy marketwas valued at US$ 118.5 Mn in 2018 and is expected to reach US$ 240.7 Mn in 2026, growing at a CAGR of 9.3% during the forecast period. With COVID-19 pandemic, many industries are transforming rapidly. The Global Canine Stem Cell Therapy Market is one of the major industries undergoing changes. This year many industries have vanished entirely from the market and many industries have risen.

Moreover, the government-backed schemes throughout the globe are offering many advantages to businesses. As the governing bodies are supporting the industries, it is a strong pillar to support the market growth of Canine Stem Cell Therapy in the upcoming decade (2020-2026). Organizations planning to move into new market segments can take the help of market indicators to draw a business plan. With the technological boom, new markets are blossoming across the globe, making it a breeding ground for new businesses.

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Global Canine Stem Cell Therapy Market 2020: Covering both the industrial and the commercial aspects of the Global Canine Stem Cell Therapy Market, the report encircles several crucial chapters that give the report an extra edge. The Global Canine Stem Cell Therapy Market report deep dives into several parts of the report that plays a crucial role in getting the holistic view of the report. The list of such crucial aspects of the report includes company profile, industry analysis, competitive dashboard, comparative analysis of the key players, regional analysis with further analysis country wise.

Global Canine Stem Cell Therapy Market Analysis by Key Players:

Any questions, Lets discuss with the analyst @ https://www.alltheresearch.com/speak-to-analyst/206

Moreover, one of the uniqueness in the report is that it also covers the country-level analysis of the regulatory scenario, technology penetration, predictive trends, and prescriptive trends. This not only gives the readers of the report the actual real-time insights but also gives country-wise analysis, that plays a vital role in decision making. The inclusion of the report is not limited to the above mention key pointers. The report also emphasizes on the market opportunities, porters five forces, and analysis of the different types of products and application of the Global Canine Stem Cell Therapy Market.

The report splits by major applications:

Then report analyzed by types:

Global Canine Stem Cell Therapy Market Report is a professional and in-depth research report on the worlds major regional market conditions of the Canine Stem Cell Therapy industry, focusing on the main regions and the main countries as Follows:

COVID-19 Impact on Canine Stem Cell Therapy Market:

The outbreak of COVID-19 has brought along a global recession, which has impacted several industries. Along with this impact COVID Pandemic has also generated few new business opportunities for Canine Stem Cell Therapy Market. Overall competitive landscape and market dynamics of Canine Stem Cell Therapy has been disrupted due to this pandemic. All these disruptions and impacts has been analysed quantifiably in this report, which is backed by market trends, events and revenue shift analysis. COVID impact analysis also covers strategic adjustments for Tier 1, 2 and 3 players of Canine Stem Cell Therapy Market.

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Table of Contents Includes Major Pointes as follows:

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Canine Stem Cell Therapy Market Analysis, Latest Trends and Regional Growth Forecast by Types and Applications 2020 - TechnoWeekly

Photo courtesy of Talaris.

Talaris Chief Executive Officer Scott Requadt sees FCR001, the companys investigational cell therapy, as a potential pipeline in a product (an experimental treatment that could have multiple uses across a number of indications).

In fact, it was that versatility of the products potential that caused Requadt to join the company as CEO in 2018 after the company, known then as Regenerex, secured $100 million in financing. At the time, Requadt helmed the venture capital group Claris that backed the Series A.

I was really enthusiastic about the company and FCR001, Requadt told BioSpace in an interview.

FCR001, an investigational, allogeneic cell therapy, was previously part of Novartis gene and cell therapy unit, until it was dissolved in 2016. When that unit dissolved, rights to FCR001 reverted to Regenerex. With the return of those rights came multiple opportunities in organ transplant and severe autoimmune disorders. Cell therapies can address complex, multi-pathway diseases and Talaris has big plans for the future of FCR001 to help patients acquire or restore immune tolerance.

Our goal is to basically do for immune tolerance what CAR-T has done for oncology, Requadt said. The same product and the same basic biology will be used. We can treat organ transplant and autoimmune diseases in the same manner.

Through FCR001, Talaris will be able to change the underlying pathology of the disease so the immune system no longer sees it as a threat, Requadt said. The companys lead program is in kidney donor transplant, but FCR001, a one-time stem cell therapy, is also being explored as a treatment for scleroderma, a multi-system autoimmune disease. If FCR001 is effective in these areas, Requadt said those successes will pave the way for use in other indications.

This is a pipeline from a single product, Requadt said of FCR001, which has received a Regenerative Medicine Advanced Therapy designation from the U.S. Food and Drug Administration (FDA).

In July, Kentucky-based Talaris dosed the first patient in its Phase III FREEDOM-1 study of FCR001 in living donor kidney transplant (LDKT) recipients. The trial is expected to enroll 120 adult patients who will receive kidney donations from living donors. The primary endpoint of the study will be the proportion of FCR001 recipients who are free from necessary drugs to maintain immunosuppression without biopsy proven acute rejection at 24 months post-transplant.

Organ transplant patients are required to continue taking drugs to suppress their immune systems to protect the new organ from immune system responses. However, those immunosuppressant treatments drugs are toxic to the kidney and can ultimately kill the transplanted organ in 10 to 15 years. The drugs can also lead to metabolic disorders and cardiovascular issues, Requadt said.

In 2018, Talaris posted positive Phase II data in LDKT recipients, with 70% of patients who received the treatment able to discontinue the use of immunosuppressant drugs. The Phase II data showed that every tolerized patient has been able to remain free of the use of chronic immunosuppressants for up to 10 years. The median follow-up following transplant was five years, with the longest case being a decade. Additionally, Requadt said the company has also seen better kidney functions in recipients who received FCR100 due to the lack of toxicity issues.

While there are other companies exploring similar approaches, Requadt said to his knowledge, no other group has a 10-year data set that demonstrates the safety and efficacy of a treatment like FRC001.

Not only has Talaris seen the impressive results in removing patients from the anchor of immunosuppressant drugs, Requadt said the use of FCR001 decreased the risk of rejection in patients whose biomarkers did not have as high a match with the kidney donors.

In addition to the Phase III study in LDKT patients, Talaris also has plans to conduct a Phase II study in LDKT Delayed Tolerance Induction and will begin research in Deceased Donor Kidney Transplant patients.

Talaris will also use FCR001 in the treatment of diffuse systemic sclerosis (SSc), a severe form of the rare autoimmune disease scleroderma, a rare and potentially fatal chronic autoimmune disease which causes progressive scarring, or fibrosis, of the bodys connective tissues. Autologous hematopoietic stem cell transplant has been shown to halt organ damage and induce remission of the disease. However, with the use of a patients own stem cells, there is a risk of disease recurrence. Also, some patients must undergo full myeloablative conditioning with or without total body irradiation, which is associated with direct organ toxicity and increased risk of future cancers. Talaris aims to harness the power of FCR001 and use stem cells from donors to lower those risks and provide an opportunity for these patients, Requadt said.

For all of these indications were using the same product and were using the same protocols with patients and were treating the patients in the same way. This has the potential to be paradigm shifting, Requadt said.

Excerpt from:
Does Talaris' Investigational Cell Therapy Have Potential to Be a 'Pipeline in a Product'? - BioSpace

Market Overview of Cancer Stem Cell Therapy Market

The Cancer Stem Cell Therapy market report provides a detailed analysis of global market size, regional and country-level market size, segmentation market growth, market share, competitive Landscape, sales analysis, impact of domestic and global market players, value chain optimization, trade regulations, recent developments, opportunities analysis, strategic market growth analysis, product launches, area marketplace expanding, and technological innovations.

The global Cancer Stem Cell Therapy market size is expected to gain market growth in the forecast period of 2020 to 2025, with a CAGR of xx%% in the forecast period of 2020 to 2025 and will expected to reach USD xx million by 2025, from USD xx million in 2019.

Get PDF Sample Copy of this Report to understand the structure of the complete report: (Including Full TOC, List of Tables & Figures, Chart) @ https://www.marketresearchhub.com/enquiry.php?type=S&repid=2802065&source=atm

Market segmentation

Cancer Stem Cell Therapy market is split by Type and by Application. For the period 2015-2025, the growth among segments provide accurate calculations and forecasts for sales by Type and by Application in terms of volume and value. This analysis can help you expand your business by targeting qualified niche markets.

segment by Type, the product can be split intoAutologous Stem Cell TransplantsAllogeneic Stem Cell TransplantsSyngeneic Stem Cell TransplantsOther

Market segment by Application, split intoHospitalClinicMedical Research InstitutionOther

Based on regional and country-level analysis, the Cancer Stem Cell Therapy market has been segmented as follows:North AmericaUnited StatesCanadaEuropeGermanyFranceU.K.ItalyRussiaNordicRest of EuropeAsia-PacificChinaJapanSouth KoreaSoutheast AsiaIndiaAustraliaRest of Asia-PacificLatin AmericaMexicoBrazilMiddle East & AfricaTurkeySaudi ArabiaUAERest of Middle East & Africa

Regional analysis is another highly comprehensive part of the research and analysis study of the global Cancer Stem Cell Therapy market presented in the report. This section sheds light on the sales growth of different regional and country-level Cancer Stem Cell Therapy markets. For the historical and forecast period 2015 to 2025, it provides detailed and accurate country-wise volume analysis and region-wise market size analysis of the global Cancer Stem Cell Therapy market.

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The report offers in-depth assessment of the growth and other aspects of the Cancer Stem Cell Therapy market in important countries (regions), including:

North America (United States, Canada and Mexico)

Europe (Germany, France, UK, Russia and Italy)

Asia-Pacific (China, Japan, Korea, India and Southeast Asia)

South America (Brazil, Argentina, etc.)

Middle East & Africa (Saudi Arabia, Egypt, Nigeria and South Africa)

Cancer Stem Cell Therapy competitive landscape provides details by vendors, including company overview, company total revenue (financials), market potential, global presence, Cancer Stem Cell Therapy sales and revenue generated, market share, price, production sites and facilities, SWOT analysis, product launch. For the period 2015-2020, this study provides the Cancer Stem Cell Therapy sales, revenue and market share for each player covered in this report.

In the competitive analysis section of the report, leading as well as prominent players of the global Cancer Stem Cell Therapy market are broadly studied on the basis of key factors. The report offers comprehensive analysis and accurate statistics on revenue by the player for the period 2015-2020. It also offers detailed analysis supported by reliable statistics on price and revenue (global level) by player for the period 2015-2020.The key players covered in this studyAVIVA BioSciencesAdnaGenAdvanced Cell DiagnosticsSilicon Biosystems

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The content of the study subjects, includes a total of 15 chapters:

Chapter 1, to describe Cancer Stem Cell Therapy product scope, market overview, market opportunities, market driving force and market risks.

Chapter 2, to profile the top manufacturers of Cancer Stem Cell Therapy , with price, sales, revenue and global market share of Cancer Stem Cell Therapy in 2018 and 2019.

Chapter 3, the Cancer Stem Cell Therapy competitive situation, sales, revenue and global market share of top manufacturers are analyzed emphatically by landscape contrast.

Chapter 4, the Cancer Stem Cell Therapy breakdown data are shown at the regional level, to show the sales, revenue and growth by regions, from 2015 to 2020.

Chapter 5, 6, 7, 8 and 9, to break the sales data at the country level, with sales, revenue and market share for key countries in the world, from 2015 to 2020.

Chapter 10 and 11, to segment the sales by type and application, with sales market share and growth rate by type, application, from 2015 to 2020.

Chapter 12, Cancer Stem Cell Therapy market forecast, by regions, type and application, with sales and revenue, from 2020 to 2025.

Chapter 13, 14 and 15, to describe Cancer Stem Cell Therapy sales channel, distributors, customers, research findings and conclusion, appendix and data source.

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Cancer Stem Cell Therapy Market: Industry Trends and Developments 2020-2025 - Zenit News

Emergen Research has published its latest report, titled Global Stem Cell Therapy Market, which is a unique compilation of the vital elements of the Stem Cell Therapy industry, including the key market growth drivers, constraints, opportunities, limitations, and threats. The micro- and macro-economic factors claimed to bolster the global market expansion in the near future have been encased in this report. The report consists of a broad database of the market dynamics intended to facilitate market estimation over the projected timeline. The latest report is highly beneficial for businesses and stakeholders looking forward to setting a robust footing in this industry.

The Global Stem Cell Therapy Market size was valued at USD 6.16 Billion in 2019 and is anticipated to reach USD 11.97 Billion by 2027 at a CAGR of 8.7%.

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The top market competitors profiled in the report include Virgin Health Bank, Celgene Corporation, ReNeuron Group plc, Biovault Family, Precious Cells International Ltd., Mesoblast Ltd., Opexa Therapeutics, Inc., Caladrius, Neuralstem, Inc., and Pluristem, among others.

The Global Stem Cell Therapy Market report is dubbed as the first study encompassing the current situation of the Stem Cell Therapy market that is gravely impacted by the COVID-19 outbreak. The global health emergency has drastically affected the global economy, causing significant repercussions on this particular business sphere. The deadly viral outbreak and the subsequent global lockdown enforcement have beleaguered the Stem Cell Therapy business landscape. Moreover, it has impeded the developmental scope of various manufacturers and buyers involved in this sector. Thus, the report offers insightful speculations about the post-COVID-19 scenario of the Stem Cell Therapy industry.

Type Outlook (Revenue, USD Million; 2017-2027)

Application Outlook (Revenue, USD Million; 2017-2027)

End-User Outlook (Revenue, USD Million; 2017-2027)

The report thoroughly scrutinizes the Stem Cell Therapy market on the basis of the global market reach and consumer bases of the key geographical segments. Under the regional analysis, the report authors have studied the presence of the global Stem Cell Therapy market across the major regions and further highlighted their respective market shares, market sizes, revenue contributions, sales networks, distribution channels, and numerous other significant aspects.

To know more about the report, visit @ https://www.emergenresearch.com/industry-report/stem-cell-therapy-market

Stem Cell Therapy Market Segmentation by Region:

Competitive Outlook:

The latest research report involves an exhaustive study of the leading companies functioning mechanisms participating in this industry. According to our team of analysts, these companies hold a considerable portion of the overall Stem Cell Therapy market share. Under this section of the report, the principal strategic initiatives led by these companies, including mergers & acquisitions, joint ventures, new business deals, new product launches, collaborations, technological upgradation, and several others, have been emphasized.

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Key Report Coverage:

Frequently asked questions addressed in the report:

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Stem Cell Therapy Market Insights Global Analysis and Forecast by (2020 2027) - The Think Curiouser

Merck Announces KEYNOTE-598 Trial Evaluating KEYTRUDA (pembrolizumab) in Combination With Ipilimumab Versus KEYTRUDA Monotherapy in Certain Patients With Metastatic Non-Small Cell Lung Cancer To Stop for Futility and Patients to Discontinue Ipilimumab

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that it will be stopping KEYNOTE-598, a Phase 3 trial investigating KEYTRUDA, Mercks anti-PD-1 therapy, in combination with ipilimumab (Yervoy ), compared with KEYTRUDA monotherapy, for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 (tumor proportion score [TPS] 50%) with no EGFR or ALK genomic tumor aberrations. Merck is discontinuing the study following the recommendation of an independent Data Monitoring Committee (DMC), which determined the benefit/risk profile of the combination did not support continuing the trial. At an interim analysis, the combination of KEYTRUDA and ipilimumab showed no incremental benefit in overall survival (OS) or progression-free survival (PFS), the studys dual primary endpoints, compared with KEYTRUDA alone and crossed futility boundaries. No new safety signals for KEYTRUDA monotherapy were observed, however the combination of KEYTRUDA and ipilimumab was associated with a higher incidence of grade 3-5 adverse events (AEs), serious AEs, and AEs leading to discontinuation or death, compared with KEYTRUDA monotherapy. Merck will inform study investigators of the recommendation from the DMC and the DMC is advising that patients in the study discontinue treatment with ipilimumab/placebo. Data from this study will be submitted for presentation at an upcoming scientific congress and communicated to regulatory agencies.

We conducted KEYNOTE-598 in order to explicitly explore whether combining our anti-PD-1 therapy, KEYTRUDA, with ipilimumab provided additional benefits beyond treatment with KEYTRUDA alone in the metastatic non-small cell lung cancer setting, said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. It is very clear that in this study, the addition of ipilimumab did not add clinical benefit but did add toxicity. KEYTRUDA monotherapy remains a standard of care for the treatment of certain patients with metastatic non-small cell lung cancer whose tumors express PD-L1.

While the combination of an anti-PD-1 therapy plus ipilimumab has been approved in certain indications, studies supporting these approvals have, for the most part, not compared the combination directly with anti-PD-1 monotherapy. Bristol Myers Squibb has reported topline results of CheckMate-915, a Phase 3 study in adjuvant melanoma that directly compared treatment with ipilimumab in combination with an anti-PD-1 therapy versus the anti-PD-1 therapy alone. In two separate news releases issued over the last year, the company announced the study did not meet its co-primary endpoints in the all-comer population or in patients whose tumors expressed PD-L1

Merck has an extensive clinical development program in lung cancer and is advancing multiple registration-enabling studies with KEYTRUDA in combination with other treatments and as monotherapy. The lung program is evaluating KEYTRUDA across all stages of disease and lines of therapy in over 200 trials with more than 10,000 patients.

About KEYNOTE-598

KEYNOTE-598 (ClinicalTrials.gov, NCT03302234 ) is a randomized, double-blind, Phase 3 trial investigating KEYTRUDA in combination with ipilimumab compared to KEYTRUDA monotherapy for the first-line treatment of patients with metastatic NSCLC whose tumors express PDL1 (TPS 50%) with no EGFR or ALK genomic tumor aberrations. The dual primary endpoints are OS and PFS. Secondary endpoints include objective response rate, duration of response and safety. The study enrolled 568 patients who were randomized (1:1) to receive:

About Lung Cancer

Lung cancer, which forms in the tissues of the lungs, usually within cells lining the air passages, is the leading cause of cancer death worldwide. Each year, more people die of lung cancer than die of colon and breast cancers combined. The two main types of lung cancer are non-small cell and small cell. Non-small cell lung cancer (NSCLC) is the most common type of lung cancer, accounting for about 85% of all cases. Small cell lung cancer (SCLC) accounts for about 10% to 15% of all lung cancers. Before 2014, the five-year survival rate for patients diagnosed in the U.S. with NSCLC and SCLC was estimated to be 5% and 6%, respectively.

About KEYTRUDA (pembrolizumab) Injection, 100 mg

KEYTRUDA is an anti-PD-1 therapy that works by increasing the ability of the bodys immune system to help detect and fight tumor cells. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.

Merck has the industrys largest immuno-oncology clinical research program. There are currently more than 1,200 trials studying KEYTRUDA across a wide variety of cancers and treatment settings. The KEYTRUDA clinical program seeks to understand the role of KEYTRUDA across cancers and the factors that may predict a patients likelihood of benefitting from treatment with KEYTRUDA, including exploring several different biomarkers.

Selected KEYTRUDA (pembrolizumab) Indications

Melanoma

KEYTRUDA is indicated for the treatment of patients with unresectable or metastatic melanoma.

KEYTRUDA is indicated for the adjuvant treatment of patients with melanoma with involvement of lymph node(s) following complete resection.

Non-Small Cell Lung Cancer

KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.

KEYTRUDA, in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, is indicated for the first-line treatment of patients with metastatic squamous NSCLC.

KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with NSCLC expressing PD-L1 [tumor proportion score (TPS) 1%] as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations, and is stage III where patients are not candidates for surgical resection or definitive chemoradiation, or metastatic.

KEYTRUDA, as a single agent, is indicated for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS 1%) as determined by an FDA-approved test, with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA.

Small Cell Lung Cancer

KEYTRUDA is indicated for the treatment of patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy and at least 1 other prior line of therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Head and Neck Squamous Cell Cancer

KEYTRUDA, in combination with platinum and fluorouracil (FU), is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent head and neck squamous cell carcinoma (HNSCC).

KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 [combined positive score (CPS) 1] as determined by an FDA-approved test.

KEYTRUDA, as a single agent, is indicated for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with disease progression on or after platinum-containing chemotherapy.

Classical Hodgkin Lymphoma

KEYTRUDA is indicated for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL).

KEYTRUDA is indicated for the treatment of pediatric patients with refractory cHL, or cHL that has relapsed after 2 or more lines of therapy.

Primary Mediastinal Large B-Cell Lymphoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or who have relapsed after 2 or more prior lines of therapy. KEYTRUDA is not recommended for treatment of patients with PMBCL who require urgent cytoreductive therapy.

Urothelial Carcinoma

KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who are not eligible for cisplatin-containing chemotherapy and whose tumors express PD-L1 [combined positive score (CPS) 10], as determined by an FDA-approved test, or in patients who are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

KEYTRUDA is indicated for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy.

Microsatellite Instability-High or Mismatch Repair Deficient Cancer

KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR)

This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. The safety and effectiveness of KEYTRUDA in pediatric patients with MSI-H central nervous system cancers have not been established.

Microsatellite Instability-High or Mismatch Repair Deficient Colorectal Cancer

KEYTRUDA is indicated for the first-line treatment of patients with unresectable or metastatic MSI-H or dMMR colorectal cancer (CRC).

Gastric Cancer

KEYTRUDA is indicated for the treatment of patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS 1) as determined by an FDA-approved test, with disease progression on or after two or more prior lines of therapy including fluoropyrimidine- and platinum-containing chemotherapy and if appropriate, HER2/neu-targeted therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Esophageal Cancer

KEYTRUDA is indicated for the treatment of patients with recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus whose tumors express PD-L1 (CPS 10) as determined by an FDA-approved test, with disease progression after one or more prior lines of systemic therapy.

Cervical Cancer

KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS 1) as determined by an FDA-approved test. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Hepatocellular Carcinoma

KEYTRUDA is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Merkel Cell Carcinoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC). This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Renal Cell Carcinoma

KEYTRUDA, in combination with axitinib, is indicated for the first-line treatment of patients with advanced renal cell carcinoma (RCC).

Tumor Mutational Burden-High

KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [10 mutations/megabase (mut/Mb)] solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. The safety and effectiveness of KEYTRUDA in pediatric patients with TMB-H central nervous system cancers have not been established.

Cutaneous Squamous Cell Carcinoma

KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) that is not curable by surgery or radiation.

Selected Important Safety Information for KEYTRUDA

Immune-Mediated Pneumonitis

KEYTRUDA can cause immune-mediated pneumonitis, including fatal cases. Pneumonitis occurred in 3.4% (94/2799) of patients with various cancers receiving KEYTRUDA, including Grade 1 (0.8%), 2 (1.3%), 3 (0.9%), 4 (0.3%), and 5 (0.1%). Pneumonitis occurred in 8.2% (65/790) of NSCLC patients receiving KEYTRUDA as a single agent, including Grades 3-4 in 3.2% of patients, and occurred more frequently in patients with a history of prior thoracic radiation (17%) compared to those without (7.7%). Pneumonitis occurred in 6% (18/300) of HNSCC patients receiving KEYTRUDA as a single agent, including Grades 3-5 in 1.6% of patients, and occurred in 5.4% (15/276) of patients receiving KEYTRUDA in combination with platinum and FU as first-line therapy for advanced disease, including Grades 3-5 in 1.5% of patients. Pneumonitis occurred in 8% (31/389) of patients with cHL receiving KEYTRUDA as a single agent, including Grades 3-4 in 2.3% of patients.

Monitor patients for signs and symptoms of pneumonitis. Evaluate suspected pneumonitis with radiographic imaging. Administer corticosteroids for Grade 2 or greater pneumonitis. Withhold KEYTRUDA for Grade 2; permanently discontinue KEYTRUDA for Grade 3 or 4 or recurrent Grade 2 pneumonitis.

Immune-Mediated Colitis

KEYTRUDA can cause immune-mediated colitis. Colitis occurred in 1.7% (48/2799) of patients receiving KEYTRUDA, including Grade 2 (0.4%), 3 (1.1%), and 4 (

Immune-Mediated Hepatitis (KEYTRUDA) and Hepatotoxicity (KEYTRUDA in Combination With Axitinib)

Immune-Mediated Hepatitis

KEYTRUDA can cause immune-mediated hepatitis. Hepatitis occurred in 0.7% (19/2799) of patients receiving KEYTRUDA, including Grade 2 (0.1%), 3 (0.4%), and 4 (

Hepatotoxicity in Combination With Axitinib

KEYTRUDA in combination with axitinib can cause hepatic toxicity with higher than expected frequencies of Grades 3 and 4 ALT and AST elevations compared to KEYTRUDA alone. With the combination of KEYTRUDA and axitinib, Grades 3 and 4 increased ALT (20%) and increased AST (13%) were seen. Monitor liver enzymes before initiation of and periodically throughout treatment. Consider more frequent monitoring of liver enzymes as compared to when the drugs are administered as single agents. For elevated liver enzymes, interrupt KEYTRUDA and axitinib, and consider administering corticosteroids as needed.

Immune-Mediated Endocrinopathies

KEYTRUDA can cause adrenal insufficiency (primary and secondary), hypophysitis, thyroid disorders, and type 1 diabetes mellitus. Adrenal insufficiency occurred in 0.8% (22/2799) of patients, including Grade 2 (0.3%), 3 (0.3%), and 4 (

Monitor patients for signs and symptoms of adrenal insufficiency, hypophysitis (including hypopituitarism), thyroid function (prior to and periodically during treatment), and hyperglycemia. For adrenal insufficiency or hypophysitis, administer corticosteroids and hormone replacement as clinically indicated. Withhold KEYTRUDA for Grade 2 adrenal insufficiency or hypophysitis and withhold or discontinue KEYTRUDA for Grade 3 or Grade 4 adrenal insufficiency or hypophysitis. Administer hormone replacement for hypothyroidism and manage hyperthyroidism with thionamides and beta-blockers as appropriate. Withhold or discontinue KEYTRUDA for Grade 3 or 4 hyperthyroidism. Administer insulin for type 1 diabetes, and withhold KEYTRUDA and administer antihyperglycemics in patients with severe hyperglycemia.

Immune-Mediated Nephritis and Renal Dysfunction

KEYTRUDA can cause immune-mediated nephritis. Nephritis occurred in 0.3% (9/2799) of patients receiving KEYTRUDA, including Grade 2 (0.1%), 3 (0.1%), and 4 (

Immune-Mediated Skin Reactions

Immune-mediated rashes, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) (some cases with fatal outcome), exfoliative dermatitis, and bullous pemphigoid, can occur. Monitor patients for suspected severe skin reactions and based on the severity of the adverse reaction, withhold or permanently discontinue KEYTRUDA and administer corticosteroids. For signs or symptoms of SJS or TEN, withhold KEYTRUDA and refer the patient for specialized care for assessment and treatment. If SJS or TEN is confirmed, permanently discontinue KEYTRUDA.

Other Immune-Mediated Adverse Reactions

Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue in patients receiving KEYTRUDA and may also occur after discontinuation of treatment. For suspected immune-mediated adverse reactions, ensure adequate evaluation to confirm etiology or exclude other causes. Based on the severity of the adverse reaction, withhold KEYTRUDA and administer corticosteroids. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Based on limited data from clinical studies in patients whose immune-related adverse reactions could not be controlled with corticosteroid use, administration of other systemic immunosuppressants can be considered. Resume KEYTRUDA when the adverse reaction remains at Grade 1 or less following corticosteroid taper. Permanently discontinue KEYTRUDA for any Grade 3 immune-mediated adverse reaction that recurs and for any life-threatening immune-mediated adverse reaction.

The following clinically significant immune-mediated adverse reactions occurred in less than 1% (unless otherwise indicated) of 2799 patients: arthritis (1.5%), uveitis, myositis, Guillain-Barr syndrome, myasthenia gravis, vasculitis, pancreatitis, hemolytic anemia, sarcoidosis, and encephalitis. In addition, myelitis and myocarditis were reported in other clinical trials, including classical Hodgkin lymphoma, and post-marketing use.

Treatment with KEYTRUDA may increase the risk of rejection in solid organ transplant recipients. Consider the benefit of treatment vs the risk of possible organ rejection in these patients.

Infusion-Related Reactions

KEYTRUDA can cause severe or life-threatening infusion-related reactions, including hypersensitivity and anaphylaxis, which have been reported in 0.2% (6/2799) of patients. Monitor patients for signs and symptoms of infusion-related reactions. For Grade 3 or 4 reactions, stop infusion and permanently discontinue KEYTRUDA.

Complications of Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)

Fatal and other serious complications can occur in patients who receive allogeneic hematopoietic stem cell transplantation (HSCT) before or after being treated with a PD-1/PD-L1 blocking antibody. Transplant-related complications include hyperacute graft-versus-host disease (GVHD), acute GVHD, chronic GVHD, hepatic veno-occlusive disease (VOD) after reduced intensity conditioning, and steroid-requiring febrile syndrome (without an identified infectious cause). These complications may occur despite intervening therapy between PD-1/PD-L1 blockade and allogeneic HSCT. Follow patients closely for evidence of transplant-related complications and intervene promptly. Consider the benefit versus risk of treatment with a PD-1/PD-L1 blocking antibody prior to or after an allogeneic HSCT.

Increased Mortality in Patients With Multiple Myeloma

In trials in patients with multiple myeloma, the addition of KEYTRUDA to a thalidomide analogue plus dexamethasone resulted in increased mortality. Treatment of these patients with a PD-1 or PD-L1 blocking antibody in this combination is not recommended outside of controlled trials.

Embryofetal Toxicity

Based on its mechanism of action, KEYTRUDA can cause fetal harm when administered to a pregnant woman. Advise women of this potential risk. In females of reproductive potential, verify pregnancy status prior to initiating KEYTRUDA and advise them to use effective contraception during treatment and for 4 months after the last dose.

Adverse Reactions

In KEYNOTE-006, KEYTRUDA was discontinued due to adverse reactions in 9% of 555 patients with advanced melanoma; adverse reactions leading to permanent discontinuation in more than one patient were colitis (1.4%), autoimmune hepatitis (0.7%), allergic reaction (0.4%), polyneuropathy (0.4%), and cardiac failure (0.4%). The most common adverse reactions (20%) with KEYTRUDA were fatigue (28%), diarrhea (26%), rash (24%), and nausea (21%).

In KEYNOTE-002, KEYTRUDA was permanently discontinued due to adverse reactions in 12% of 357 patients with advanced melanoma; the most common (1%) were general physical health deterioration (1%), asthenia (1%), dyspnea (1%), pneumonitis (1%), and generalized edema (1%). The most common adverse reactions were fatigue (43%), pruritus (28%), rash (24%), constipation (22%), nausea (22%), diarrhea (20%), and decreased appetite (20%).

In KEYNOTE-054, KEYTRUDA was permanently discontinued due to adverse reactions in 14% of 509 patients; the most common (1%) were pneumonitis (1.4%), colitis (1.2%), and diarrhea (1%). Serious adverse reactions occurred in 25% of patients receiving KEYTRUDA. The most common adverse reaction (20%) with KEYTRUDA was diarrhea (28%).

In KEYNOTE-189, when KEYTRUDA was administered with pemetrexed and platinum chemotherapy in metastatic nonsquamous NSCLC, KEYTRUDA was discontinued due to adverse reactions in 20% of 405 patients. The most common adverse reactions resulting in permanent discontinuation of KEYTRUDA were pneumonitis (3%) and acute kidney injury (2%). The most common adverse reactions (20%) with KEYTRUDA were nausea (56%), fatigue (56%), constipation (35%), diarrhea (31%), decreased appetite (28%), rash (25%), vomiting (24%), cough (21%), dyspnea (21%), and pyrexia (20%).

In KEYNOTE-407, when KEYTRUDA was administered with carboplatin and either paclitaxel or paclitaxel protein-bound in metastatic squamous NSCLC, KEYTRUDA was discontinued due to adverse reactions in 15% of 101 patients. The most frequent serious adverse reactions reported in at least 2% of patients were febrile neutropenia, pneumonia, and urinary tract infection. Adverse reactions observed in KEYNOTE-407 were similar to those observed in KEYNOTE-189 with the exception that increased incidences of alopecia (47% vs 36%) and peripheral neuropathy (31% vs 25%) were observed in the KEYTRUDA and chemotherapy arm compared to the placebo and chemotherapy arm in KEYNOTE-407.

In KEYNOTE-042, KEYTRUDA was discontinued due to adverse reactions in 19% of 636 patients with advanced NSCLC; the most common were pneumonitis (3%), death due to unknown cause (1.6%), and pneumonia (1.4%). The most frequent serious adverse reactions reported in at least 2% of patients were pneumonia (7%), pneumonitis (3.9%), pulmonary embolism (2.4%), and pleural effusion (2.2%). The most common adverse reaction (20%) was fatigue (25%).

In KEYNOTE-010, KEYTRUDA monotherapy was discontinued due to adverse reactions in 8% of 682 patients with metastatic NSCLC; the most common was pneumonitis (1.8%). The most common adverse reactions (20%) were decreased appetite (25%), fatigue (25%), dyspnea (23%), and nausea (20%).

Adverse reactions occurring in patients with SCLC were similar to those occurring in patients with other solid tumors who received KEYTRUDA as a single agent.

In KEYNOTE-048, KEYTRUDA monotherapy was discontinued due to adverse events in 12% of 300 patients with HNSCC; the most common adverse reactions leading to permanent discontinuation were sepsis (1.7%) and pneumonia (1.3%). The most common adverse reactions (20%) were fatigue (33%), constipation (20%), and rash (20%).

In KEYNOTE-048, when KEYTRUDA was administered in combination with platinum (cisplatin or carboplatin) and FU chemotherapy, KEYTRUDA was discontinued due to adverse reactions in 16% of 276 patients with HNSCC. The most common adverse reactions resulting in permanent discontinuation of KEYTRUDA were pneumonia (2.5%), pneumonitis (1.8%), and septic shock (1.4%). The most common adverse reactions (20%) were nausea (51%), fatigue (49%), constipation (37%), vomiting (32%), mucosal inflammation (31%), diarrhea (29%), decreased appetite (29%), stomatitis (26%), and cough (22%).

In KEYNOTE-012, KEYTRUDA was discontinued due to adverse reactions in 17% of 192 patients with HNSCC. Serious adverse reactions occurred in 45% of patients. The most frequent serious adverse reactions reported in at least 2% of patients were pneumonia, dyspnea, confusional state, vomiting, pleural effusion, and respiratory failure. The most common adverse reactions (20%) were fatigue, decreased appetite, and dyspnea. Adverse reactions occurring in patients with HNSCC were generally similar to those occurring in patients with melanoma or NSCLC who received KEYTRUDA as a monotherapy, with the exception of increased incidences of facial edema and new or worsening hypothyroidism.

In KEYNOTE-204, KEYTRUDA was discontinued due to adverse reactions in 14% of 148 patients with cHL. Serious adverse reactions occurred in 30% of patients; those 1% included pneumonitis, pneumonia, pyrexia, myocarditis, acute kidney injury, febrile neutropenia, and sepsis. Three patients died from causes other than disease progression. The most common adverse reactions (20%) were upper respiratory tract infection (41%), musculoskeletal pain (32%), diarrhea (22%), and pyrexia, fatigue, and cough (20% each).

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Merck Announces KEYNOTE-598 Trial Evaluating KEYTRUDA in Combination With Ipilimumab Versus KEYTRUDA Monotherapy in Certain Patients With Metastatic...

KENILWORTH, N.J., & WOODCLIFF LAKE, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK):

KEYTRUDA (pembrolizumab) Plus LENVIMA (lenvatinib) Demonstrated Statistically Significant Improvement in Progression-Free Survival (PFS), Overall Survival (OS) and Objective Response Rate (ORR) Versus Sunitinib as First-Line Treatment for Patients With Advanced Renal Cell Carcinoma

LENVIMA Plus Everolimus Also Showed Statistically Significant Improvement in PFS and ORR Endpoints Versus Sunitinib

Results of Investigational Phase 3 KEYNOTE-581/CLEAR Trial (Study 307) to be Presented at Upcoming Medical Meeting

Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Eisai today announced new investigational data demonstrating positive top-line results from the pivotal Phase 3 KEYNOTE-581/CLEAR trial (Study 307). In the trial, the combinations of KEYTRUDA, Mercks anti-PD-1 therapy, plus LENVIMA, the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai, and LENVIMA plus everolimus were evaluated versus sunitinib for the first-line treatment of patients with advanced renal cell carcinoma (RCC). KEYTRUDA plus LENVIMA met the trials primary endpoint of progression-free survival (PFS) and its key secondary endpoints of overall survival (OS) and objective response rate (ORR), demonstrating a statistically significant and clinically meaningful improvement in PFS, OS and ORR versus sunitinib in the intention-to-treat (ITT) study population. LENVIMA plus everolimus also met the trials primary endpoint of PFS and a key secondary endpoint of ORR, demonstrating a statistically significant and clinically meaningful improvement in PFS and ORR versus sunitinib in the ITT study population. The ITT population included patients across all Memorial Sloan Kettering Cancer Center (MSKCC) risk groups (favorable, intermediate and poor). The safety profiles of both KEYTRUDA plus LENVIMA and LENVIMA plus everolimus were consistent with previously reported studies. Merck and Eisai will discuss these data with regulatory authorities worldwide, with the intent to submit marketing authorization applications based on these results, which will be presented at an upcoming medical meeting.

The results for KEYTRUDA plus LENVIMA versus sunitinib, which showed a statistically significant improvement in progression-free survival, overall survival and objective response rate, build on the growing scientific evidence that supports the investigation of KEYTRUDA-based combinations for the first-line treatment of advanced renal cell carcinoma, said Dr. Gregory Lubiniecki, Associate Vice President, Oncology Clinical Research, Merck Research Laboratories. Merck and Eisai are committed to working together to continue to explore the potential of the KEYTRUDA plus LENVIMA combination, particularly in areas of great unmet need such as renal cell carcinoma.

The results from KEYNOTE-581/CLEAR (Study 307) support the potential use of KEYTRUDA plus LENVIMA for the first-line treatment of advanced RCC. These data also support the potential first-line use of LENVIMA plus everolimus, which is already approved in advanced RCC following prior antiangiogenic therapy, said Dr. Takashi Owa, Vice President, Chief Medicine Creation and Chief Discovery Officer, Oncology Business Group at Eisai. These findings energize our efforts as we continue to advance our understanding and address the unmet needs of patients with difficult-to-treat cancers.

Merck and Eisai are continuing to study the KEYTRUDA plus LENVIMA combination through the LEAP (LEnvatinib And Pembrolizumab) clinical program across 19 trials in 13 different tumor types (endometrial carcinoma, hepatocellular carcinoma, melanoma, non-small cell lung cancer, RCC, squamous cell carcinoma of the head and neck, urothelial cancer, biliary tract cancer, colorectal cancer, gastric cancer, glioblastoma, ovarian cancer and triple-negative breast cancer).

About KEYNOTE-581/CLEAR (Study 307)

KEYNOTE-581/CLEAR (Study 307) is a multi-center, randomized, open-label, Phase 3 trial (ClinicalTrials.gov, NCT02811861) evaluating LENVIMA in combination with KEYTRUDA or in combination with everolimus versus sunitinib for the first-line treatment of patients with advanced RCC. The primary endpoint is PFS by independent review per RECIST v1.1 criteria. Key secondary endpoints include OS, ORR and safety. The study enrolled approximately 1,050 patients who were randomized to one of three treatment arms to receive:

About Renal Cell Carcinoma (RCC)

Worldwide, it is estimated there were more than 403,000 new cases of kidney cancer diagnosed and more than 175,000 deaths from the disease in 2018. In the U.S. alone, it is estimated there will be nearly 74,000 new cases of kidney cancer diagnosed and almost 15,000 deaths from the disease in 2020. Renal cell carcinoma is by far the most common type of kidney cancer; about nine out of 10 kidney cancers are RCCs. Renal cell carcinoma is about twice as common in men as in women. Most cases of RCC are discovered incidentally during imaging tests for other abdominal diseases. Approximately 30% of patients with RCC will have metastatic disease at diagnosis, and as many as 40% will develop metastases after primary surgical treatment for localized RCC. Survival is highly dependent on the stage at diagnosis, and with a five-year survival rate of 12% for metastatic disease, the prognosis for these patients is poor.

About KEYTRUDA (pembrolizumab) Injection, 100 mg

KEYTRUDA is an anti-PD-1 therapy that works by increasing the ability of the bodys immune system to help detect and fight tumor cells. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.

Merck has the industrys largest immuno-oncology clinical research program. There are currently more than 1,200 trials studying KEYTRUDA across a wide variety of cancers and treatment settings. The KEYTRUDA clinical program seeks to understand the role of KEYTRUDA across cancers and the factors that may predict a patient's likelihood of benefitting from treatment with KEYTRUDA, including exploring several different biomarkers.

Selected KEYTRUDA (pembrolizumab) Indications

Melanoma

KEYTRUDA is indicated for the treatment of patients with unresectable or metastatic melanoma.

KEYTRUDA is indicated for the adjuvant treatment of patients with melanoma with involvement of lymph node(s) following complete resection.

Non-Small Cell Lung Cancer

KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.

KEYTRUDA, in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, is indicated for the first-line treatment of patients with metastatic squamous NSCLC.

KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with NSCLC expressing PD-L1 [tumor proportion score (TPS) 1%] as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations, and is stage III where patients are not candidates for surgical resection or definitive chemoradiation, or metastatic.

KEYTRUDA, as a single agent, is indicated for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS 1%) as determined by an FDA-approved test, with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA.

Small Cell Lung Cancer

KEYTRUDA is indicated for the treatment of patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy and at least 1 other prior line of therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Head and Neck Squamous Cell Cancer

KEYTRUDA, in combination with platinum and fluorouracil (FU), is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent head and neck squamous cell carcinoma (HNSCC).

KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 [combined positive score (CPS) 1] as determined by an FDA-approved test.

KEYTRUDA, as a single agent, is indicated for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with disease progression on or after platinum-containing chemotherapy.

Classical Hodgkin Lymphoma

KEYTRUDA is indicated for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL).

KEYTRUDA is indicated for the treatment of pediatric patients with refractory cHL, or cHL that has relapsed after 2 or more lines of therapy.

Primary Mediastinal Large B-Cell Lymphoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or who have relapsed after 2 or more prior lines of therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. KEYTRUDA is not recommended for treatment of patients with PMBCL who require urgent cytoreductive therapy.

Urothelial Carcinoma

KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who are not eligible for cisplatin-containing chemotherapy and whose tumors express PD-L1 [combined positive score (CPS) 10], as determined by an FDA-approved test, or in patients who are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

KEYTRUDA is indicated for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy.

Microsatellite Instability-High or Mismatch Repair Deficient Cancer

KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR)

This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. The safety and effectiveness of KEYTRUDA in pediatric patients with MSI-H central nervous system cancers have not been established.

Microsatellite Instability-High or Mismatch Repair Deficient Colorectal Cancer

KEYTRUDA is indicated for the first-line treatment of patients with unresectable or metastatic MSI-H or dMMR colorectal cancer (CRC).

Gastric Cancer

KEYTRUDA is indicated for the treatment of patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS 1) as determined by an FDA-approved test, with disease progression on or after two or more prior lines of therapy including fluoropyrimidine- and platinum-containing chemotherapy and if appropriate, HER2/neu-targeted therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Esophageal Cancer

KEYTRUDA is indicated for the treatment of patients with recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus whose tumors express PD-L1 (CPS 10) as determined by an FDA-approved test, with disease progression after one or more prior lines of systemic therapy.

Cervical Cancer

KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS 1) as determined by an FDA-approved test. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Hepatocellular Carcinoma

KEYTRUDA is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Merkel Cell Carcinoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC). This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Renal Cell Carcinoma

KEYTRUDA, in combination with axitinib, is indicated for the first-line treatment of patients with advanced renal cell carcinoma (RCC).

Endometrial Carcinoma

KEYTRUDA, in combination with LENVIMA, is indicated for the treatment of patients with advanced endometrial carcinoma that is not MSI-H or dMMR, who have disease progression following prior systemic therapy and are not candidates for curative surgery or radiation. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trial.

Tumor Mutational Burden-High

KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [10 mutations/megabase (mut/Mb)] solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. The safety and effectiveness of KEYTRUDA in pediatric patients with TMB-H central nervous system cancers have not been established.

Cutaneous Squamous Cell Carcinoma

KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) that is not curable by surgery or radiation.

Selected Important Safety Information for KEYTRUDA (pembrolizumab)

Immune-Mediated Pneumonitis

KEYTRUDA can cause immune-mediated pneumonitis, including fatal cases. Pneumonitis occurred in 3.4% (94/2799) of patients with various cancers receiving KEYTRUDA, including Grade 1 (0.8%), 2 (1.3%), 3 (0.9%), 4 (0.3%), and 5 (0.1%). Pneumonitis occurred in 8.2% (65/790) of NSCLC patients receiving KEYTRUDA as a single agent, including Grades 3-4 in 3.2% of patients, and occurred more frequently in patients with a history of prior thoracic radiation (17%) compared to those without (7.7%). Pneumonitis occurred in 6% (18/300) of HNSCC patients receiving KEYTRUDA as a single agent, including Grades 3-5 in 1.6% of patients, and occurred in 5.4% (15/276) of patients receiving KEYTRUDA in combination with platinum and FU as first-line therapy for advanced disease, including Grades 3-5 in 1.5% of patients.

Monitor patients for signs and symptoms of pneumonitis. Evaluate suspected pneumonitis with radiographic imaging. Administer corticosteroids for Grade 2 or greater pneumonitis. Withhold KEYTRUDA for Grade 2; permanently discontinue KEYTRUDA for Grade 3 or 4 or recurrent Grade 2 pneumonitis.

Immune-Mediated Colitis

KEYTRUDA can cause immune-mediated colitis. Colitis occurred in 1.7% (48/2799) of patients receiving KEYTRUDA, including Grade 2 (0.4%), 3 (1.1%), and 4 (<0.1%). Monitor patients for signs and symptoms of colitis. Administer corticosteroids for Grade 2 or greater colitis. Withhold KEYTRUDA for Grade 2 or 3; permanently discontinue KEYTRUDA for Grade 4 colitis.

Immune-Mediated Hepatitis (KEYTRUDA) and Hepatotoxicity (KEYTRUDA in Combination With Axitinib)

Immune-Mediated Hepatitis

KEYTRUDA can cause immune-mediated hepatitis. Hepatitis occurred in 0.7% (19/2799) of patients receiving KEYTRUDA, including Grade 2 (0.1%), 3 (0.4%), and 4 (<0.1%). Monitor patients for changes in liver function. Administer corticosteroids for Grade 2 or greater hepatitis and, based on severity of liver enzyme elevations, withhold or discontinue KEYTRUDA.

Hepatotoxicity in Combination With Axitinib

KEYTRUDA in combination with axitinib can cause hepatic toxicity with higher than expected frequencies of Grades 3 and 4 ALT and AST elevations compared to KEYTRUDA alone. With the combination of KEYTRUDA and axitinib, Grades 3 and 4 increased ALT (20%) and increased AST (13%) were seen. Monitor liver enzymes before initiation of and periodically throughout treatment. Consider more frequent monitoring of liver enzymes as compared to when the drugs are administered as single agents. For elevated liver enzymes, interrupt KEYTRUDA and axitinib, and consider administering corticosteroids as needed.

Immune-Mediated Endocrinopathies

KEYTRUDA can cause adrenal insufficiency (primary and secondary), hypophysitis, thyroid disorders, and type 1 diabetes mellitus. Adrenal insufficiency occurred in 0.8% (22/2799) of patients, including Grade 2 (0.3%), 3 (0.3%), and 4 (<0.1%). Hypophysitis occurred in 0.6% (17/2799) of patients, including Grade 2 (0.2%), 3 (0.3%), and 4 (<0.1%). Hypothyroidism occurred in 8.5% (237/2799) of patients, including Grade 2 (6.2%) and 3 (0.1%). The incidence of new or worsening hypothyroidism was higher in 1185 patients with HNSCC (16%) receiving KEYTRUDA, as a single agent or in combination with platinum and FU, including Grade 3 (0.3%) hypothyroidism. Hyperthyroidism occurred in 3.4% (96/2799) of patients, including Grade 2 (0.8%) and 3 (0.1%), and thyroiditis occurred in 0.6% (16/2799) of patients, including Grade 2 (0.3%). Type 1 diabetes mellitus, including diabetic ketoacidosis, occurred in 0.2% (6/2799) of patients.

Monitor patients for signs and symptoms of adrenal insufficiency, hypophysitis (including hypopituitarism), thyroid function (prior to and periodically during treatment), and hyperglycemia. For adrenal insufficiency or hypophysitis, administer corticosteroids and hormone replacement as clinically indicated. Withhold KEYTRUDA for Grade 2 adrenal insufficiency or hypophysitis and withhold or discontinue KEYTRUDA for Grade 3 or Grade 4 adrenal insufficiency or hypophysitis. Administer hormone replacement for hypothyroidism and manage hyperthyroidism with thionamides and beta-blockers as appropriate. Withhold or discontinue KEYTRUDA for Grade 3 or 4 hyperthyroidism. Administer insulin for type 1 diabetes, and withhold KEYTRUDA and administer antihyperglycemics in patients with severe hyperglycemia.

Immune-Mediated Nephritis and Renal Dysfunction

KEYTRUDA can cause immune-mediated nephritis. Nephritis occurred in 0.3% (9/2799) of patients receiving KEYTRUDA, including Grade 2 (0.1%), 3 (0.1%), and 4 (<0.1%) nephritis. Nephritis occurred in 1.7% (7/405) of patients receiving KEYTRUDA in combination with pemetrexed and platinum chemotherapy. Monitor patients for changes in renal function. Administer corticosteroids for Grade 2 or greater nephritis. Withhold KEYTRUDA for Grade 2; permanently discontinue for Grade 3 or 4 nephritis.

Immune-Mediated Skin Reactions

Immune-mediated rashes, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) (some cases with fatal outcome), exfoliative dermatitis, and bullous pemphigoid, can occur. Monitor patients for suspected severe skin reactions and based on the severity of the adverse reaction, withhold or permanently discontinue KEYTRUDA and administer corticosteroids. For signs or symptoms of SJS or TEN, withhold KEYTRUDA and refer the patient for specialized care for assessment and treatment. If SJS or TEN is confirmed, permanently discontinue KEYTRUDA.

Other Immune-Mediated Adverse Reactions

Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue in patients receiving KEYTRUDA and may also occur after discontinuation of treatment. For suspected immune-mediated adverse reactions, ensure adequate evaluation to confirm etiology or exclude other causes. Based on the severity of the adverse reaction, withhold KEYTRUDA and administer corticosteroids. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Based on limited data from clinical studies in patients whose immune-related adverse reactions could not be controlled with corticosteroid use, administration of other systemic immunosuppressants can be considered. Resume KEYTRUDA when the adverse reaction remains at Grade 1 or less following corticosteroid taper. Permanently discontinue KEYTRUDA for any Grade 3 immune-mediated adverse reaction that recurs and for any life-threatening immune-mediated adverse reaction.

The following clinically significant immune-mediated adverse reactions occurred in less than 1% (unless otherwise indicated) of 2799 patients: arthritis (1.5%), uveitis, myositis, Guillain-Barr syndrome, myasthenia gravis, vasculitis, pancreatitis, hemolytic anemia, sarcoidosis, and encephalitis. In addition, myelitis and myocarditis were reported in other clinical trials, including classical Hodgkin lymphoma, and postmarketing use.

Treatment with KEYTRUDA may increase the risk of rejection in solid organ transplant recipients. Consider the benefit of treatment vs the risk of possible organ rejection in these patients.

Infusion-Related Reactions

KEYTRUDA can cause severe or life-threatening infusion-related reactions, including hypersensitivity and anaphylaxis, which have been reported in 0.2% (6/2799) of patients. Monitor patients for signs and symptoms of infusion-related reactions. For Grade 3 or 4 reactions, stop infusion and permanently discontinue KEYTRUDA.

Complications of Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)

Immune-mediated complications, including fatal events, occurred in patients who underwent allogeneic HSCT after treatment with KEYTRUDA. Of 23 patients with cHL who proceeded to allogeneic HSCT after KEYTRUDA, 6 (26%) developed graft-versus-host disease (GVHD) (1 fatal case) and 2 (9%) developed severe hepatic veno-occlusive disease (VOD) after reduced-intensity conditioning (1 fatal case). Cases of fatal hyperacute GVHD after allogeneic HSCT have also been reported in patients with lymphoma who received a PD-1 receptorblocking antibody before transplantation. Follow patients closely for early evidence of transplant-related complications such as hyperacute graft-versus-host disease (GVHD), Grade 3 to 4 acute GVHD, steroid-requiring febrile syndrome, hepatic veno-occlusive disease (VOD), and other immune-mediated adverse reactions.

In patients with a history of allogeneic HSCT, acute GVHD (including fatal GVHD) has been reported after treatment with KEYTRUDA. Patients who experienced GVHD after their transplant procedure may be at increased risk for GVHD after KEYTRUDA. Consider the benefit of KEYTRUDA vs the risk of GVHD in these patients.

Increased Mortality in Patients With Multiple Myeloma

In trials in patients with multiple myeloma, the addition of KEYTRUDA to a thalidomide analogue plus dexamethasone resulted in increased mortality. Treatment of these patients with a PD-1 or PD-L1 blocking antibody in this combination is not recommended outside of controlled trials.

Embryofetal Toxicity

Based on its mechanism of action, KEYTRUDA can cause fetal harm when administered to a pregnant woman. Advise women of this potential risk. In females of reproductive potential, verify pregnancy status prior to initiating KEYTRUDA and advise them to use effective contraception during treatment and for 4 months after the last dose.

Adverse Reactions

In KEYNOTE-006, KEYTRUDA was discontinued due to adverse reactions in 9% of 555 patients with advanced melanoma; adverse reactions leading to permanent discontinuation in more than one patient were colitis (1.4%), autoimmune hepatitis (0.7%), allergic reaction (0.4%), polyneuropathy (0.4%), and cardiac failure (0.4%). The most common adverse reactions (20%) with KEYTRUDA were fatigue (28%), diarrhea (26%), rash (24%), and nausea (21%).

In KEYNOTE-002, KEYTRUDA was permanently discontinued due to adverse reactions in 12% of 357 patients with advanced melanoma; the most common (1%) were general physical health deterioration (1%), asthenia (1%), dyspnea (1%), pneumonitis (1%), and generalized edema (1%). The most common adverse reactions were fatigue (43%), pruritus (28%), rash (24%), constipation (22%), nausea (22%), diarrhea (20%), and decreased appetite (20%).

In KEYNOTE-054, KEYTRUDA was permanently discontinued due to adverse reactions in 14% of 509 patients; the most common (1%) were pneumonitis (1.4%), colitis (1.2%), and diarrhea (1%). Serious adverse reactions occurred in 25% of patients receiving KEYTRUDA. The most common adverse reaction (20%) with KEYTRUDA was diarrhea (28%).

In KEYNOTE-189, when KEYTRUDA was administered with pemetrexed and platinum chemotherapy in metastatic nonsquamous NSCLC, KEYTRUDA was discontinued due to adverse reactions in 20% of 405 patients. The most common adverse reactions resulting in permanent discontinuation of KEYTRUDA were pneumonitis (3%) and acute kidney injury (2%). The most common adverse reactions (20%) with KEYTRUDA were nausea (56%), fatigue (56%), constipation (35%), diarrhea (31%), decreased appetite (28%), rash (25%), vomiting (24%), cough (21%), dyspnea (21%), and pyrexia (20%).

In KEYNOTE-407, when KEYTRUDA was administered with carboplatin and either paclitaxel or paclitaxel protein-bound in metastatic squamous NSCLC, KEYTRUDA was discontinued due to adverse reactions in 15% of 101 patients. The most frequent serious adverse reactions reported in at least 2% of patients were febrile neutropenia, pneumonia, and urinary tract infection. Adverse reactions observed in KEYNOTE-407 were similar to those observed in KEYNOTE-189 with the exception that increased incidences of alopecia (47% vs 36%) and peripheral neuropathy (31% vs 25%) were observed in the KEYTRUDA and chemotherapy arm compared to the placebo and chemotherapy arm in KEYNOTE-407.

In KEYNOTE-042, KEYTRUDA was discontinued due to adverse reactions in 19% of 636 patients with advanced NSCLC; the most common were pneumonitis (3%), death due to unknown cause (1.6%), and pneumonia (1.4%). The most frequent serious adverse reactions reported in at least 2% of patients were pneumonia (7%), pneumonitis (3.9%), pulmonary embolism (2.4%), and pleural effusion (2.2%). The most common adverse reaction (20%) was fatigue (25%).

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KEYTRUDA (pembrolizumab) Plus LENVIMA (lenvatinib) Demonstrated Statistically Significant Improvement in Progression-Free Survival (PFS), Overall...