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AUGMENT-101: Phase II results of revumenib in NPM1-mutated R/R AML
Results from the phase II portion of the AUGMENT-101 trial (NCT04065399) evaluating the efficacy and safety of revumenib, a potent selective menin inhibitor, with or without a CYP3A4 inhibitor, in 84 patients with NPM1-mutated (NPM1m) relapsed/refractory (R/R) acute myeloid leukemia (AML) were published by Arellano et al. in Blood.
Key data: Among the efficacy-evaluable patients (n = 64), the complete remission (CR) plus CR with partial hematologic recovery (CRh) rate was 23.4% (p = 0.0014), with a composite CR (CRc) rate of 29.7%. The overall response rate (ORR) was 46.9%, and the median duration of response (DoR) was 4.7 months. Grade ≥3 treatment-emergent adverse events (TEAEs) were reported in 91.7% of all patients, while Grade ≥3 QTcF prolongation occurred in 22.6%. Treatment-related discontinuations were reported in 4.8%.
Key learning: Revumenib demonstrated a clinically meaningful benefit and was well tolerated in patients with NPM1m R/R AML, suggesting its potential to significantly improve outcomes in this high-risk subgroup.
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