StemCell Therapy

06/12/2020 | 04:48pm EDT

Abstract #EP829:

Mutations in RAS pathway genes correlate with Type

of Failure to Azacitidine: Genomic Analysis at

Randomization onto the INSPIRE Trial

Koichi Takahashi, MD1, Anna Jonasova, MD, PhD2, Selina M. Luger, MD, FRCPC3, Aref Al-Kali,

MD4, David Valcrcel, MD5, Erica D. Warlick, MD6, Wieslaw W. Jedrzejczak, MD, PhD7, Mara

Dez-Campelo, MD, PhD8, Patrick S. Zbyszewski, MBA9, Christopher Cavanaugh9, Richard C.

Woodman, MD9& Steven M. Fruchtman, MD9, Guillermo Garcia-Manero, MD1

1University of Texas MD Anderson Cancer Center, Department of Leukemia, Houston, TX; 21st Medical Department - Hematology, General Hospital, Prague, Czech Republic; 3Abramson

Cancer Center, University of Pennsylvania, Philadelphia, PA; 4Division of Hematology, Mayo Clinic, Rochester, MN; 5Planta Baixa, Hospital Universitari Vall d'Hebron, Barcelona, Spain; 6Division of Hematology, Oncology and Transplantation, University of Minnesota, Minneapolis, MN; 7MTZ Clinical Research, Medical University of Warsaw, Warsaw, Poland; 8Hematology Department, Institute of Biomedical Research of Salamanca, University Hospital of Salamanca, Salamanca, Spain; 9Onconova Therapeutics, Inc., Newtown, PA; 1Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX

EHA May2020

Confidential

1

Introduction

EHA May2020

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Eligibility:

2:1

R

A

Rigosertib + best

N

supportive care

D

N = 240

O

Primary

M

Endpoint:

I

Overall

Z

Survival

A

Physician's Choice of

(288 Events)

T

Treatment + best

I

supportive care

O

N = 120

N

Primary Objective: To compare the overall survival (OS) of patients in the rigosertib group vs PC arm in all patients and a sub-group of patients with IPSS-R very high risk;

Exploratory Objective: Correlation of overall survival and clinical responses with mutational status;

EHA May2020

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3

Key Inclusion Criteria

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Methodology

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Table 1: Patient Demographics (N=190)

Number of patients (%)

Sex

Female

67

(35)

Male

121 (64)

Unknown

2

(1)

Race

Asian

22

(12)

Black

3

(2)

White

152 (80)

Other

6

(3)

Unknown

7

(4)

Age (yr)

Median

73

Range

54 - 82

ECOG performance Status

0

40

(21)

1

87

(46)

2

19

(10)

Read more from the original source:
MUTATIONS IN RAS PATHWAY GENES CORRELATE WITH TYPE OF FAILURE TO AZACITIDINE : GENOMIC ANALYSIS AT RANDOMIZATION ONTO THE INSPIRE TRIAL - SLIDE...

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