Trial Evaluating Magrolimab Plus Azacitidine in Higher-Risk MDS Discontinued

Gilead has decided to discontinue the phase 3 ENHANCE study evaluating magrolimab plus azacitidine for the first-line treatment for patients with higher-risk myelodysplastic syndromes (MDS).

Magrolimab is an investigational monoclonal antibody that binds to CD47 and blocks the inhibitory CD47-signal regulatory protein (SIRPα) interaction. This enhances the ability of macrophages and other phagocytes to identify and destroy cancer cells.

The randomized, double-blind ENHANCE study (ClinicalTrials.gov Identifier: NCT04313881) included 520 patients 18 years of age and older with higher-risk MDS. Patients were randomly assigned to receive either magrolimab plus azacitidine or placebo plus azacitidine.

The coprimary endpoints were overall survival and complete remission rate, defined as the proportion of patients who reach morphologic complete remission based on investigator-assessed International Working Group 2006 MDS criteria prior to initiation of any new MDS therapy including stem cell therapy.

A decision was made to end the trial due to futility based on a planned analysis. “The health and well-being of patients are our top priorities and while this is disappointing news it confirms the challenges of treating HR-MDS, where no new class of treatments have been approved in nearly 20 years,” said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences.

The Company is investigating magrolimab across 10 potential indications, including 2 trials for the treatment of acute myeloid leukemia (ClinicalTrials.gov Identifier: ENHANCE-2 [NCT04778397] and ENHANCE-3 [NCT05079230]).

This article originally appeared on MPR