Globenewswire·2025-12-08 11:50Core Insights - Syndax Pharmaceuticals presented new data on Revuforj (revumenib) at the 67th ASH Annual Meeting, highlighting its efficacy and safety in treating acute leukemia, particularly in patients with NPM1m, KMT2Ar, and NUP98r mutations [1][2][3] Efficacy and Safety Data - The overall response rate (ORR) for revumenib was reported at 77% (10/13) in a retrospective review, with a complete remission (CR) rate of 31% (4/13) and 75% (9/12) achieving measurable residual disease (MRD) negativity [1][4][5] - In a Phase 2 SAVE trial, the ORR was 86% (18/21) and the CR rate was 76% (16/21), with 100% MRD negativity among responders [6][11] - Revumenib demonstrated a favorable safety profile, with only 24% (4/17) experiencing Grade 3 or 4 non-hematological adverse events, and low rates of dose reductions and discontinuations at 6% each [5][13] Clinical Trials and Future Directions - Syndax has initiated pivotal frontline trials for revumenib in patients unfit for intensive chemotherapy and in fit patients, aiming to expand clinical data supporting its use [2][23] - Multiple ongoing and planned trials are evaluating revumenib in combination with standard therapies for newly diagnosed patients with specific genetic mutations [22][23] Pediatric Applications - A retrospective review of revumenib as post-HSCT maintenance in children showed that all ten patients were alive at a median follow-up of 19 months, with a 90% relapse-free survival rate [7][8] Company Overview - Syndax Pharmaceuticals is focused on advancing innovative cancer therapies, with Revuforj being a first-in-class menin inhibitor approved for treating relapsed or refractory acute leukemia [22][40]