ASH 2021 | Phase Ib/II study of magrolimab in combination with azacitidine and venetoclax in patients with AML

Despite high initial response rates to azacitidine plus venetoclax, the majority of patients with acute myeloid leukemia (AML) treated with this combination relapse and outcomes in relapsed/refractory (R/R) patients are poor. Naval Daver, MD, University of Texas MD Anderson Cancer Center, Houston, TX, presents the preliminary results of a Phase Ib/II trial (NCT04435691) evaluating the addition of magrolimab to azacitidine and venetoclax in patients with R/R AML, based on promising results from pre-clinical studies showing that this combination prolonged survival in AML patient-derived xenografts. After the recommended Phase II dose (RP2D) was determined in the Phase Ib study, the Phase II study enrolled 38 patients that were divided into three cohorts: a frontline cohort, a R/R venetoclax-naïve AML cohort and a R/R venetoclax-exposed AML cohort. The complete remission (CR)/CR with incomplete hematologic recovery (CRi) rate in newly diagnosed patients was 94%, with the majority having an adverse ELN risk. In the R/R venetoclax-naïve and venetoclax-exposed AML cohorts, the CR/CRi rates were 63% and 27% respectively. Although this novel treatment combination was considered safe, anemia should be monitored carefully. The trial is ongoing. This interview took place at the 63rd ASH Annual Meeting and Exposition congress in Atlanta, GA.