Abstract
INTRODUCTION: This phase 2 study evaluated magrolimab+venetoclax (VEN)+azacitidine (AZA) in untreated, unfit acute myeloid leukaemia (AML) and magrolimab+mitoxantrone+etoposide+cytarabine in relapsed/refractory (R/R) AML. METHODS: Endpoints included complete remission rate (CRR), overall response rate (ORR), overall survival (OS) and safety. RESULTS: Eighteen and 36 patients were enrolled into the unfit and R/R AML arms, respectively. CRR was 38.9% and 25.0%, ORR was 66.7% and 38.9%, and median OS was 15.3 and 10.5 months in the unfit AML and R/R AML arms, respectively. No dose-limiting toxicities or magrolimab-related deaths occurred. CONCLUSION: Magrolimab was safely combined with existing AML therapies with no new safety signals. CLINICAL TRIAL REGISTRATION: This trail was registered at www.clinicaltrials.gov as NCT04778410.