TOPLINE:

Ivosidenib combined with azacitidine extended median overall survival to 29.3 months compared with 7.9 months for placebo plus azacitidine in newly diagnosed isocitrate dehydrogenase 1 (IDH1)-mutated acute myeloid leukemia (AML). The combination therapy also improved hematologic recovery and increased transfusion independence rate to 53.8% vs 17.1% with placebo.

METHODOLOGY:

A total of 148 patients with newly diagnosed IDH1-mutated AML who were unfit for intensive chemotherapy were randomized to receive either ivosidenib-azacitidine (n = 73) or placebo-azacitidine (n = 75).

Treatment consisted of 500 mg ivosidenib or placebo administered orally once daily, combined with subcutaneous or intravenous 75 mg/m² azacitidine for 7 days in 28-day cycles, with randomization stratified

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