Revumenib + Intensive Chemotherapy for Newly Diagnosed Acute Myeloid Leukemia Harboring Genetic Alterations in KMT2A, NPM1, or NUP98: Updated Phase 1 Results From SNDX-5613-0708

Ibrahim Aldoss, MD, reviews updated phase 1 results from the SNDX-5613-0708 study evaluating revumenib plus intensive chemotherapy in patients with newly diagnosed acute myeloid leukemia (AML) harboring KMT2A, NPM1, or NUP98 genetic alterations. As of November 30, 2025, 15 patients were treated at dose level 1 and 20 at dose level 2. The combination produced deep responses, with an overall response rate and composite complete remission rate of 97% and a complete remission rate with complete count recovery of 77%; most responders achieved measurable residual disease negativity. The safety profile was manageable and broadly consistent across both dose levels, with one dose-limiting toxicity of grade 3 QTcF prolongation and a low rate of differentiation syndrome. Time to neutrophil and platelet count recovery was comparable with intensive chemotherapy alone. These findings support continued evaluation of revumenib plus intensive chemotherapy at dose level 2 in the phase 3 REVEAL-ND trial.