Gilead halts phase 3 AML trial

Sept. 28, 2023

Gilead Sciences announced this week its plans to halt its ENHANCE-2 study evaluating its investigational CD47 inhibitor in acute myeloid leukemia (AML) with TP53 mutations. 

The decision followed an ad hoc analysis and review by an independent data monitoring committee, leading Gilead to determine that magrolimab is unlikely to provide a survival benefit compared to standard care for AML with TP53 mutations.

The trial evaluated the impact of magrolimab plus azacitidine, a type of chemo therapy, on overall survival in untreated AML with TP53 mutations, compared to venetoclax plus azacitidine or intensive chemotherapy.

Magrolimab, developed by Forty-Seven, was designed to target the CD47 antigen on human cell surfaces. In 2020, Gilead acquired Forty-Seven in a $4.9 billion transaction, further advancing the development of the drug.

Development for magrolimab has not been a smooth ride for Gilead. Last month, the drugmaker revealed that the FDA had put the ENHANCE-2 study on partial hold — for the second time. In January 2022, development of magrolimab in combination with azacitidine was halted for patients with AML and myelodysplastic syndrome due to investigator-reported unexpected adverse events.