Gilead pulls Phase III study of magrolimab plus azacitidine in higher-risk MDS

22 July 2023

Late Friday, US biotech major Gilead Sciences (Nasdaq: GILD) announced that the Phase III ENHANCE study in higher-risk myelodysplastic syndromes (MDS) has been discontinued due to futility based on a planned analysis.

The company noted that the safety data seen in this study is consistent with the known magrolimab profile and adverse events that are typical in this patient population. Gilead recommends discontinuing treatment with magrolimab in patients with MDS.

Gilead describes magrolimab as a potential first-in-class, anti-CD47 immunotherapy with a clinical development program spanning 10 potential indications including ongoing trials in solid tumors and two pivotal trials: ENHANCE-2 study in acute myeloid leukemia (AML) with TP53 mutations and ENHANCE-3 in first-line, unfit AML.

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