Study
| International, multicenter, randomized, open-label, phase 3 trial |
| Age ≥60 years, IDH2 gene mutated, de novo or secondary AML |
| Previously 2 or 3 prior AML- directed therapies |
| Enasidenib 100 mg/day orally (N:158) vs CCR (azacitidine N:69; LDAC N:37; IDAC N:33; or BSC:N:22) |
Efficacy
| mOS: 6.5 m vs 6.2 m (HR:0.86; 95% CI, 0.67-1.10; P = .23) |
| 1 year OS: 38% vs 26% (∆11%; 95% CI, 1%-22%) |
| mEFS:4.9 m vs 2.6 m (HR, 0.68; 95% CI, 0.52-0.91; P = .008) |
Safety
| All grades AE: 77% vs 61%, nausea: 22.3% vs 15.6%, blood bilirubin increased:19.7% vs 0.7%, thrombocytopenia:15.3% vs 10.6% |
| Grade ≥3 AEs 47% vs 35% |
| Serious AEs 22% vs 21%; febrile neutropenia, 2% vs 8% |
Blood. 2022 Jun 17;blood.2021014901.
http://doi.org/10.1182/blood.2021014901
Reviewed by Hasan Cagri Yildirim, MD on Sep 20, 2022
