AGILE — Ivosidenib Plus Azacitidine in Newly Diagnosed IDH1-Mutated Acute Myeloid Leukemia (AGILE)

Phase 3 · 2022 · Acute Myeloid Leukemia

Design

Randomized double-blind trial of ivosidenib plus azacitidine versus placebo plus azacitidine.

Population

Newly diagnosed IDH1-mutated acute myeloid leukemia in patients ineligible for intensive induction chemotherapy.

Primary Endpoint

event-free survival (EFS)

Key Result

Overall survival 24.0 vs 7.9 months (HR 0.44) and improved event-free survival with ivosidenib plus azacitidine.

Guideline Impact

NCCN-listed ivosidenib plus azacitidine for newly diagnosed IDH1-mutated AML in patients ineligible for intensive therapy