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New Protocol: Enasidenib in older patients with late-stage mutant-IDH2 relapsed/refractory AML

New Protocol: Enasidenib in older patients with late-stage mutant-IDH2 relapsed/refractory AML
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.

de Botton, Stéphane et al. “Enasidenib vs conventional care in mutant-IDH2 relapsed/refractory acute myeloidleukemia: a randomized, phase 3 trial.”

https://doi.org/10.1182/blood.2021014901

Reviewed by Hasan Çağrı Yıldırım, MD on Jul 06, 2022

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