“Gilead Sciences has stopped its ENHANCE-2 study in acute myeloid leukemia (AML) with TP53 mutations. Based on an ad hoc analysis, and following review by an independent data monitoring committee, Gilead concluded that magrolimab is unlikely to demonstrate a survival benefit in AML with TP53 mutations compared to standard of care. There were no new safety signals identified and the safety profile was comparable between treatment arms. ENHANCE-2 is a randomized, open-label, Phase 3 trial to determine if magrolimab plus azacitidine improves overall survival, compared to physician’s choice of venetoclax plus azacitidine or intensive chemotherapy in previously untreated AML with TP53 mutations. Gilead is working with study investigators on appropriate next steps for patients enrolled in this study. This decision follows the previously announced partial clinical hold placed on the ENHANCE-2 study.”
