Compared with placebo and azacitidine, the combination of ivosidenib plus azacitidine prolongs event-free survival for patients with newly diagnosed IDH1-mutated acute myeloid leukemia (AML) who are ineligible for induction chemotherapy, according to a study published in the New England Journal of Medicine. Pau Montesinos, MD, PhD, and colleagues conducted a phase III trial of patients with newly diagnosed IDH1-mutated AML who were ineligible for intensive induction chemotherapy. Patients were randomly assigned to receive oral ivosidenib and subcutaneous or IV azacitidine or matched placebo and azacitidine. Event-free survival was significantly longer in the ivosidenib plus azacitidine group than in the placebo plus azacitidine group at a median follow-up of 12.4 months. The estimated probabilities that a patient would remain event-free at 12 months were 37% and 12% in the ivosidenib plus azacitidine and placebo plus azacitidine groups, respectively. Median overall survival times were 24.0 and 7.9 months in the ivosidenib plus azacitidine and the placebo plus azacitidine groups, respectively.
