ASH 2021 | ENHANCE-2: Phase III study of magrolimab plus azacitidine in untreated TP53-mutant AML

TP53 mutations are found in 10-15% of newly diagnosed acute myeloid leukemia (AML) cases and are associated with a poor prognosis. Currently, treatments for this patient population represent an unmet clinical need. Naval Daver, MD, University of Texas MD Anderson Cancer Center, Houston, TX, discusses the rationale and design of ENHANCE-2 (NCT04778397), a Phase III study comparing the efficacy, safety, and tolerability of magrolimab plus azacitidine versus physician’s choice of venetoclax plus azacitidine or intensive chemotherapy in 346 previously untreated patients with TP53-mutant AML. In this study, patients treated with magrolimab and azacitidine or venetoclax and azacitidine will remain on treatment until disease progression, relapse, loss of clinical benefit, high toxicity or stem cell transplant (SCT). The primary endpoint is overall survival (OS), with a key secondary endpoint of complete response rate. This interview took place at the 63rd ASH Annual Meeting and Exposition congress in Atlanta, GA.