StemCell Therapy

16 Abstracts, Including Three Oral Presentations, Highlight Breadth of Companys Innovation in Immuno-Oncology for Patients with Blood Cancers

Kite Data Highlight Yescarta Long-Term Efficacy in Relapsed/Refractory Large B-Cell Lymphoma, its Potential as An Earlier Line of Therapy in DLBCL, as well as Results in Other Cancers, and One-Year Follow-up Results for Tecartus in Relapsed Mantle Cell Lymphoma

Magrolimab Demonstrates Continued Response Rates in Updated Results of Phase 1b Study of Acute Myeloid Leukemia Patients, Including Those with TP53 Mutation

Gilead Sciences, Inc. (Nasdaq: GILD) and Kite, a Gilead Company, today announced that 16 abstracts, including three oral presentations from the companies combined immuno-oncology research and development programs, have been accepted for presentation at the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition. The meeting, which is being held virtually on December 5-8, 2020, will feature presentations on Yescarta (axicabtagene ciloleucel), Tecartus (brexucabtagene autoleucel, KTE-X19) and other ongoing research from Kites chimeric antigen receptor (CAR) T cell therapy development program, as well as magrolimab, Gileads first-in-class, investigational anti-CD47 monoclonal antibody.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201105005130/en/

The evidence supporting our innovation in hematologic malignancies continues to grow, providing assurance of the lasting and positive impact our diverse oncology pipeline could achieve over time, said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences. We continue to see broad potential across our oncology portfolio anchored by Kite in cell therapy and Gileads anti-CD47 monoclonal antibody to transform care for patients with hard-to-treat blood cancers.

New Long-Term Efficacy Data and the Potential of CAR T Therapy for More Patients

Building on three-year data presented at ASH 2019, overall survival results at four years from the pivotal ZUMA-1 trial of Yescarta in patients with refractory large B-cell lymphoma will be presented (Abstract #1187). Additionally, new data include one-year follow-up results from the ZUMA-2 study evaluating KTE-X19 in relapsed or refractory mantle cell lymphoma (Abstract #1120), as well as several studies evaluating the potential of Yescarta in new indications include an interim analysis of ZUMA-12 in first-line large B-cell lymphoma among patients with high-risk features (Abstract #405) and the ZUMA-5 primary analysis in relapsed or refractory indolent non-Hodgkin lymphoma (NHL), including follicular lymphoma (FL) and marginal zone lymphoma (MZL; Abstract #700).

Data from the ZUMA-5 primary analysis form the basis for the supplemental Biologics License Application (sBLA) for Yescarta currently under review by the U.S. Food & Drug Administration (FDA). Yescarta has previously been granted a Breakthrough Therapy Designation by the FDA for relapsed or refractory FL or MZL after at least two prior therapies and has been granted a Priority Review with a target action date, under the Prescription Drug User Fee Act (PDUFA), of March 5, 2021.

Our data at ASH build on the established strengths of our CAR T franchise, including practice-changing potential in new cancers, said Ken Takeshita, MD, Kites Global Head of Clinical Development. As we become the first company to present four-year CAR T data from a pivotal study in large B-cell lymphoma and continue to expand our leadership in cell therapy across different hematologic malignancies and into earlier lines of therapy, we remain committed to bringing the benefits of cell therapies to as many patients as possible.

Harnessing Potential First-in-Class Anti-CD47 Antibody in Difficult-to-Treat Malignancies

Researchers will give an oral presentation of updated results from the Phase 1b study of magrolimab in patients with previously-untreated acute myeloid leukemia (AML) who cannot undergo treatment with intensive chemotherapy, including patients with TP53 -mutant AML (Abstract #330). The FDA recently assigned Breakthrough Designation to magrolimab, in combination with azacitidine for the treatment of adult patients with newly-diagnosed MDS including intermediate-, high-, or very high-risk tumor types to expedite the development and regulatory review of this investigational treatment. Magrolimab also received PRIME Designation for treatment of MDS from the European Medicines Agency (EMA).

Dates and times for all accepted abstracts are as follows:

Area of Focus, Presentation Number and Date/Time

Abstract Title

Oral Presentations

Acute Myeloid Leukemia

Abstract #330

Sunday, Dec 6

(12:30pm ET / 9:30am PT)

The First-in-Class Anti-CD47 Antibody Magrolimab Combined with Azacitidine Is Well-Tolerated and Effective in AML Patients: Phase 1b Results

Large B-cell Lymphoma

Abstract #405

Sunday, Dec 6

(4:15pm ET / 1:15pm PT)

Interim Analysis of ZUMA-12: A Phase 2 Study of Axicabtagene Ciloleucel (Axi-Cel) as First-Line Therapy in Patients (Pts) with High-Risk Large B Cell Lymphoma (LBCL)

Non-Hodgkin Lymphoma Abstract #700

Monday, Dec 7

(4:30pm ET / 1:30pm PT)

Primary Analysis of ZUMA-5: A Phase 2 Study of Axicabtagene Ciloleucel (Axi-Cel) in Patients With Relapsed/Refractory (R/R) Indolent Non-Hodgkin Lymphoma (iNHL)

Poster Presentations

Follicular Lymphoma

Abstract #1145

Saturday, Dec 5

(10:00am ET / 7:00am PT)

Safety Profile of Idelalisib in Patients with Refractory Follicular Lymphoma: Interim Analysis of a Noninterventional Study

Large B-cell Lymphoma Abstract #1187

Saturday, Dec 5

(10:00am ET / 7:00am PT)

Long-Term Survival and Gradual Recovery of B Cells in Patients With Refractory Large B Cell Lymphoma Treated With Axicabtagene Ciloleucel (Axi-Cel)

Large B-cell Lymphoma Abstract #2100

Sunday, Dec 6

(10:00am ET / 7:00am PT)

Outcomes of Patients (Pts) in ZUMA-9, A Multicenter, Open-Label Study of Axicabtagene Ciloleucel (Axi-Cel) in Relapsed/Refractory Large B Cell Lymphoma (R/R LBCL) for Expanded Access and Commercial Out-of-Specification (OOS) Product

Large B-cell Lymphoma

Abstract #1224

Saturday, Dec 5

(10:00am ET / 7:00am PT)

The First Retrospective Commercial Claims-Based Analysis of CAR T Treated Patients With Relapsed or Refractory Large B-Cell Lymphoma (R/R LBCL)

Large B-cell Lymphoma

Abstract #2500

Sunday, Dec 6

(10:00am ET / 7:00am PT)

Cost and Healthcare Utilization in Relapsed/Refractory Diffuse Large B-Cell Lymphoma: A Real-World Analysis of Medicare Beneficiaries Receiving Chimeric Antigen Receptor T-Cell Vs. Autologous and Allogeneic Hematopoietic Stem Cell Transplants

Large B-cell Lymphoma

Abstract #2548

Sunday, Dec 6

(10:00am ET / 7:00am PT)

Burden of Illness and Outcomes in the 2nd Line Treatment of Large B-Cell Lymphoma: A Real-World Comparison of Medicare Beneficiaries with and without Stem Cell Transplants

Large B-cell Lymphoma

Abstract #1646

Saturday, Dec 5

(10:00am ET / 7:00am PT)

Lines of Therapy in Patients with Relapsed or Refractory Large B-Cell Lymphoma and Stem Cell Transplant-Intended Treatment

Mantle Cell Lymphoma

Abstract #1120

Saturday, Dec 5

(10:00am ET / 7:00am PT)

One-Year Follow-Up of ZUMA-2, the Multicenter, Registrational Study of KTE-X19 in Patients With Relapsed/Refractory Mantle Cell Lymphoma

Mantle Cell Lymphoma

Abstract #1126

Saturday, Dec 5

(10:00am ET / 7:00am PT)

Pharmacological Profile and Clinical Outcomes of KTE-X19 by Prior Bruton Tyrosine Kinase Inhibitors (BTKi) Exposure or Mantle Cell Lymphoma (MCL) Morphology in Patients With Relapsed/Refractory (R/R) MCL in the ZUMA-2 Trial

Non-Hodgkin Lymphoma

Abstract #2036

Sunday, Dec 6

(10:00am ET / 7:00am PT)

Retreatment With Axicabtagene Ciloleucel (Axi-Cel) in Patients With Relapsed/Refractory Indolent Non-Hodgkin Lymphoma in ZUMA-5

Trials-In-Progress

Acute Lymphoblastic Leukemia & Non-Hodgkin Lymphoma

Abstract #1896

Sunday, Dec 6

(10:00am ET / 7:00am PT)

ZUMA-4: A Phase 1/2 Multicenter Study of KTE-X19 in Pediatric and Adolescent Patients With Relapsed/Refractory B Cell Acute Lymphoblastic Leukemia or Non-Hodgkin Lymphoma

Large B-cell Lymphoma

Abstract #2103

Sunday, Dec 6

(10:00am ET / 7:00am PT)

ZUMA-19: A Phase 1/2 Multicenter Study of Lenzilumab Use with Axicabtagene Ciloleucel (Axi-Cel) in Patients (Pts) With Relapsed or Refractory Large B Cell Lymphoma (R/R LBCL)

Online Publication

Follicular Lymphoma

Efficacy Outcomes of Treatments for Double Relapsed/Refractory Follicular Lymphoma (R/R FL): A Systematic Literature Review

For more information, including a complete list of abstract titles at the meeting, please visit: https://ash.confex.com/ash/2020/webprogram/start.html .

Yescarta was the first CAR T cell therapy to be approved by the FDA for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, and high grade B-cell lymphoma and DLBCL arising from FL. Yescarta is not indicated for the treatment of patients with primary central nervous system lymphoma. In July, Tecartus became the first CAR T cell therapy to receive accelerated approval from the FDA for the treatment of relapsed or refractory mantle cell lymphoma, based on overall response rate and durability of response. Continued approval for this indication may be contingent upon additional data from a confirmatory trial. The U.S. Prescribing Information for Yescarta and Tecartus each have BOXED WARNINGS for the risks of CRS and neurologic toxicities, and Yescarta and Tecartus are each approved with a risk evaluation and mitigation strategy (REMS) due to these risks; see below for Important Safety Information.

The uses of Yescarta in relapsed or refractory FL or MZL or as a first-line treatment for patients with large B-cell lymphoma and high-risk genetics are investigational and not approved anywhere globally. Its efficacy and safety have not been established for these indications.

Magrolimab is investigational and not approved anywhere globally. Its efficacy and safety have not been established. More information about clinical trials with magrolimab is available at http://www.clinicaltrials.gov .

ABOUT MAGROLIMAB

Magrolimab is a first-in-class, investigational monoclonal antibody against CD47 and macrophage checkpoint inhibitor that is designed to interfere with recognition of CD47 by the SIRP receptor on macrophages, thus blocking the dont eat me signal used by cancer cells to avoid being ingested by macrophages. Magrolimab is being developed in several hematologic and solid tumor malignancies, including MDS. Magrolimab has been granted Fast Track Designation for the treatment of MDS, AML, DLBCL and FL. Magrolimab has also been granted Orphan Drug Designation by the FDA and EMA for treatment of MDS and AML.

About Yescarta

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Gilead and Kite to Share Latest Scientific Advances in Hematologic Malignancies at ASH 2020 - Investing News Network

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