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New Reference: Ivosidenib and Azacitidine in IDH1-Mutated Acute Myeloid Leukemia

New Reference: Ivosidenib and Azacitidine in IDH1-Mutated Acute Myeloid Leukemia
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 Apr 21;386(16):1519-1531.

Montesinos, Pau et al. “Ivosidenib and Azacitidine in IDH1-Mutated Acute Myeloid Leukemia.

https://doi.org/10.1056/nejmoa2117344

Reviewed by Hasan Çağrı Yıldırım, MD on May 30, 2022

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