Posted: Wednesday, September 7, 2022
The search for a safe and tolerable treatment regimen for patients with TP53-mutant acute myeloid leukemia (AML) remains an important area of clinical research, according to a presentation given at the European Hematology Association (EHA) 2022 Congress (Abstract P551). Use of the antibody-blocking CD47 agent magrolimab with azacitidine has demonstrated activity in AML unresponsive to intensive chemotherapy and may prove to be an effective treatment in the management of this patient population, according to Naval G. Daver, MD, of The University of Texas MD Anderson Cancer Center, Houston, and colleagues.
This open-label, phase III study aims to compare two different treatment regimens in 346 patients with previously untreated TP53-mutant AML. Patients will be randomly assigned to receive either magrolimab plus azacitidine or physician’s choice of venetoclax plus azacitidine or “7+3” chemotherapy. Intravenous (IV) magrolimab will be administered at 1 mg/kg on days 1 and 4, 15 mg/kg on day 8, and 30 mg/kg on days 11 and 15 during the first 18-day cycle. Subsequently, patients will receive weekly 30-mg/kg doses for a total of five doses, followed by every other week after the fifth dose. Treatment with venetoclax plus azacitidine will adhere to labeled indications. Patients who are assigned to receive 7+3 chemotherapy will receive 100 or 200 mg/m2 of cytarabine on days 1 through 7 and one to two induction cycles with IV idarubicin or daunorubicin on days 1 through 3.
The study goal is for all patients to remain on treatment until loss of clinical benefit, unacceptable toxicities, disease progression, relapse, or stem cell transplantation. The main endpoints of this study are overall survival in patients receiving nonintensive therapy and overall survival in all patients.
Disclosure: The study authors reported no conflicts of interest.