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Biologic subtypes of acute myeloid leukemia (AML) are defined by mutations in pathogenically relevant genes, including IDH1 (isocitrate dehydrogenase 1), which portends an adverse clinical outcome. Now, in a phase 3 multicenter, industry-sponsored trial, investigators evaluated the IDH1 inhibitor ivosidenib (IVO) in previously untreated patients with IDH1-mutated AML who were not eligible for intensive induction chemotherapy.
A total of 146 patients were randomized to receive azacitidine (AZA) intravenously or subcutaneously for 7 days of 28-day cycles plus either oral IVO (500 mg/day) or placebo. Treatment continued until progression or unacceptable toxicity. The primary end point was event-free survival (EFS), defined as absence of complet…