* ENHANCE-2
Research type
Research Study
Full title
A Phase 3, Randomized, Open-Label Study Evaluating the Safety and Efficacy of Magrolimab in Combination with Azacitidine versus Physician’s Choice of Venetoclax in Combination with Azacitidine or Intensive Chemotherapy in Previously Untreated Patients with TP53 Mutant Acute Myeloid Leukemia
IRAS ID
297376
Contact name
Paresh Vyas
Contact email
Sponsor organisation
Gilead Sciences, Inc.
Eudract number
2020-003949-11
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
IND Number, 147229
Duration of Study in the UK
4 years, 0 months, 8 days
Research summary
Summary of Research
Acute Myeloid Leukemia (AML) is a rare type of blood cancer, with around 3,100 people diagnosed with it each year in the UK. Approximatively 10 to 15% of AML patients have certain changes in their TP53 gene, also called mutations. These patients have a very poor prognosis and no therapies have yet been approved for this patient group.This is a randomised open-label study evaluating an experimental drug named magrolimab. Magrolimab is an antibody designed to target and block a protein present on cancer cells called CD47. Blocking CD47 with magrolimab may enable the body’s immune system to find and destroy the cancer cells.
The purpose of this study is to compare the effects of magrolimab in combination with a drug called azacitidine, to those of commonly used treatments (venetoclax in combination with azacitidine or chemotherapy with daunorubicin or idarubicin in combination with cytarabine) to find out which is better for treating patients with AML who have mutations in the TP53 gene and who never received treatment for AML.
Approximately 346 participants from about 140 locations worldwide (including the United States, Canada, Europe, Hong Kong and Australia) will be randomised to this study. Participants will be in the study for about 15 months or longer, and may be required to visit the hospital between around 24 and 140 times in this period, depending on the treatment they are assigned to.
Summary of Results
This is a summary of the main results from this study. The individual results of each participant might be different and are not in this summary.
How long did participants live for after joining the study, in the group of participants appropriate for non-intensive therapy?
Researchers wanted to find out how long participants lived (overall survival time), after joining the study.The results are presented for the non-intensive therapy groups, Group 1 (magrolimab plus azacitidine) versus Group 2 (venetoclax plus azacitidine). Overall survival time was measured as the length of time the participants joined the study until the death of the participant due to any reason. This was measured for each participant and the median number of months the participants lived for was calculated for all participants in each group. Median is defined as the middle value of a list of values ordered from smallest to largest. In this analysis,
the median survival time was calculated using a statistical model. It uses the ‘already occurred deaths’ and the ‘participants at risk’ to find the survival chance of participants. The results showed that the participants who took magrolimab plus azacitidine had lesser survival time than participants who took venetoclax plus azacitidine.
Researchers did not see any benefit of magrolimab plus azacitidine treatment in participants with AML with TP53 mutation.The Sponsor closed the study earlier than planned as the treatment of magrolimab plus azacitidine did not work as expected.
REC name
South Central - Hampshire A Research Ethics Committee
REC reference
22/SC/0347
Date of REC Opinion
23 Aug 2021
REC opinion
Further Information Favourable Opinion