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New indication: Olutasidenib for relapsed or refractory acute myeloid leukemia with a susceptible IDH1 mutation

New indication: Olutasidenib for relapsed or refractory acute myeloid leukemia with a susceptible IDH1 mutation
Study:
  • Phase 1/2, multicenter, open-label
  • Treatment-naive and Relapsed or refractory AML; MDS with an IDH1 mutation
  • Olutasidenib monotherapy (n=32) vs. combination with Azacitidine (n=46)
Efficacy:
  • Relapsed or refractory AML: ORR 41% vs. 46%
  • For treatment-naïve AML: ORR 25% vs. 77%
Safety:
  • Grade 3: febrile neutropenia(22% vs. 28%); anemia (22% vs. 20%); pneumonia (16% vs. 9%)

Lancet Haematol. 2023 Jan;10(1): e46-e58.

Watts M J.et al. Olutasidenib alone or with azacitidine in IDH1-mutated acute myeloid leukaemia and myelodysplastic syndrome: phase 1 results of a phase 1/2 trial

https://doi.org/10.1016/S2352-3026(22)00292-7

Reviewed by Elvin CHALABİYEV, MD on Jan 30, 2023

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