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