Study
| Double-blind, randomized, placebo-controlled, phase 3 trial |
| Newly diagnosed IDH1-mutated acute myeloid leukemia |
| Ineligible for intensive induction chemotherapy |
| Oral ivosidenib and azacitidine (N:72) or placebo and azacitidine (N:74) |
Efficacy
| HR for EFS 0.33; [0.16-0.69, P:0.002] |
| 12 months EFS: 37% vs 12% |
| Median OS: 24.0 vs 7.9 months |
Safety
| Grade >= 3 AEs: febrile neutropenia (28% vs. 34%), neutropenia (27% vs. 16%) |
| Any grade bleeding 41% vs 29% |
N Engl J Med 2022; 386:1519-1531
Ivosidenib and Azacitidine in IDH1-Mutated Acute Myeloid Leukemia
http://doi.org/10.1056/NEJMoa2117344
Reviewed by Hasan Cagri Yildirim, MD on May 20, 2022
