Multinational phase 3 study of addition of ivosidenib to azacitidine for newly diagnosed IDH1-mutated AML

The combination of ivosidenib (an inhibitor of mutant isocitrate dehydrogenase 1) and azacitidine showed encouraging clinical activity in a phase 1b trial involving patients with newly diagnosed IDH1-mutated acute myeloid leukemia. The multinational phase 3 AGILE study evaluated addition of ivosidenib to azacitidine for IDH1-mutated AML in patients who were ineligible for intensive induction chemotherapy. The study showed that ivosidenib-azacitidine provided significant clinical benefit compared with placebo-azacitidine in this difficult-to-treat population (quick take video summary).