Gilead Sciences, Inc., discontinued the phase III ENHANCE study, which was evaluating magrolimab plus azacitidine as firstline treatments in higher-risk myelodysplastic syndromes (MDS). The manufacturer discontinued the study because of futility based on planned analysis and consequently recommended discontinuing magrolimab treatment in patients with MDS.
ENHANCE is a randomized, double-blind study that enrolled more than 500 patients. Participants were randomized to receive either magrolimab plus azacitidine or azacitidine alone. Complete response and overall survival were the primary endpoints of the study, while secondary endpoints included transfusion independence, duration of response, progression-free survival, time to progression to acute myeloid leukemia (AML), and more.
Magrolimab, an anti-CD47 immunotherapy, is also being evaluated as treatment for AML in two additional trials, ENHANCE-2 and ENHANCE-3. The trials are evaluating the treatment in AML with TP53 mutations and in firstline, unfit AML, respectively.
“The health and well-being of patients are our top priorities, and while this is disappointing news, it confirms the challenges of treating [higher-risk MDS] where no new class of treatments has been approved in nearly 20 years,” said Merdad Parsey, MD, PhD, chief medical officer of Gilead Sciences.
Source: Gilead Sciences, Inc., July 21, 2023.