Clinical TrialJun 11, 2026, 07:04 AM
Syndax Revuforj Shows 97% CRc in Ph 1 AML, 88% ORR in Ph 2 R/R AML
AI Summary
Syndax Pharmaceuticals highlighted robust Revuforj (revumenib) data at the EHA 2026 Congress, showcasing strong activity across multiple acute leukemia subtypes and settings. Key findings included an 82% overall response rate in a real-world study, a 97% composite complete remission rate in a Phase 1 trial for newly diagnosed AML, and an 88% overall response rate in the Phase 2 SAVE trial for relapsed/refractory AML. These results underscore the potential for revumenib, an FDA-approved menin inhibitor, to significantly improve patient outcomes.
Key Highlights
- Real-world ROAR study showed 82% ORR and 64% CR/CRh rate in R/R NPM1m or KMT2Ar patients.
- Phase 1 trial of revumenib with intensive chemotherapy achieved 97% CRc and 86% MRD negativity in newly diagnosed AML.
- Post-hoc analysis of AUGMENT-101 trial showed an observed 1-year OS of 95% for patients resuming revumenib post-HSCT.
- Phase 1 trial and expanded access demonstrated 28% ORR in R/R NUP98r acute leukemia.
- Phase 2 SAVE trial reported 88% ORR, 68% MRD negativity, and 45% transplant rate in R/R AML patients.
- Revuforj is the first and only FDA-approved menin inhibitor for R/R AML with NPM1m or KMT2A translocation.
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