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Gilead calls off phase 3 ENHANCE study of magrolimab in higher-risk myelodysplastic

Gilead recently called off its phase 3 ENHANCE study, which was looking at the combination of magrolimab and azacitidine in patients with higher-risk myelodysplastic syndrome. Based on an interim analysis, the experiment was terminated due to futility. In nearly 500 individuals with untreated MDS at intermediate, high, or very high risk, the randomized study compared magrolimab plus azacitidine versus placebo plus azacitidine. Patients were given magrolimab in conjunction with azacitidine, commencing with priming doses and progressing to weekly and then biweekly dosages. The primary goals of the trial were complete remission and overall survival, with secondary endpoints including response duration, progression-free survival, and transformation to acute myeloid leukemia. While the safety data was consistent with magrolimab’s established safety profile, the preliminary analysis concluded that the combination was unsafe.

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