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Early Trial Results on Adding Sabatolimab to Standard Therapy for Patients With AML

By: Joshua D. Madera, MS
Posted: Wednesday, August 3, 2022

For patients with newly diagnosed acute myeloid leukemia (AML), the addition of the anti-TIM3 monoclonal antibody sabatolimab to the standard treatment regimen of venetoclax plus azacitidine appears to be both safe and tolerable, according to a presentation given at the European Hematology Association (EHA) 2022 Congress (Abstract P582). This combination treatment was comparable and efficacious at doses of 400 mg and 800 mg, thus supporting the initiation of sabatolimab therapy at 800 mg in the expansion cohort of the phase II STIMULUS-AML1 study, explained Amer M. Zeidan, MBBS, MHS, of Yale University and Yale Cancer Center, New Haven, and colleagues.

A total of 18 patients with newly diagnosed AML who were unfit for intensive chemotherapy were recruited for this study. Patients were stratified to receive either 400 mg (n = 5) or 800 mg (n = 13) of sabatolimab every 4 weeks plus 400 mg of venetoclax daily and 75 mg/m2 of azacitidine on 7 days of a 28-day cycle.

The study findings revealed that nine patients have continued to receive ongoing treatment. Patients discontinued treatment due to progressive disease (n = 3), treatment-related adverse events (n = 3), planned stem cell transplantation (n = 2), and physician decision (n = 1). Additionally, the most common treatment-related adverse events included febrile neutropenia (50%), neutropenia (39%), constipation (39%), thrombocytopenia (33%), and anemia (33%). Furthermore, dose interruption occurred for six patients receiving sabatolimab and 14 patients receiving venetoclax, and dose reduction occurred for five patients receiving venetoclax. Moreover, one dose-limiting toxicity (asymptomatic myocarditis) was reported in a patient from cohort 2.

Disclosure: The authors reported no conflicts of interest.


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