SOHO 2021: Early Results With Magrolimab Plus Azacitidine in AML
Posted: Monday, September 13, 2021
During the 2021 Society of Hematologic Oncology (SOHO) Annual Meeting, David Sallman, MD, of the H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, and colleagues presented their early research findings on the combination of the first-in-class anti-CD47 antibody magrolimab with azacitidine in patients with acute myeloid leukemia (AML; Abstract AML-196). According to the researchers, this treatment combination appeared to be well tolerated and effective in patients with and without mutations of TP53, and a phase III trial has been planned.
This open-label, phase Ib study enrolled 52 patients with treatment-naive AML who were unfit to receive intensive chemotherapy. Participants were administered a priming/intrapatient dose-escalation regimen of magrolimab as well as azacitidine. Of the total population, 65% of patients had TP53 mutations, and 64% had poor-risk cytogenetics.
Overall, magrolimab plus azacitidine demonstrated a similar safety profile as that of azacitidine alone. Approximately 15% of individuals experienced treatment-related adverse events, such as anemia (31%), neutropenia (19%), fatigue (19%), blood bilirubin increase (19%), thrombocytopenia (17%), and nausea (15%). Of note, no immune-related adverse events were observed, and on-target anemia was found to be short-lived and reversible.
The time to response was 2.04 months, with an objective response, complete response, and complete response with incomplete blood cell count recovery observed in 22, 15, and 4 of 34 evaluable patients, respectively; 11 patients achieved stable disease, 1 had a partial response, and 1 experienced disease progression. The majority (71%) of participants with TP53 mutations (n = 21) achieved an objective response, followed by complete response (48%), stable disease (24%), and complete response with incomplete blood cell count recovery (19%). At a median follow-up of 4 and 12 months, respectively, the median overall survival for individuals with and without TP53 mutations was 12.9 and 18.9 months, respectively.
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