Syndax presents Revuforj clinical data across acute leukemia subtypes
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Syndax Pharmaceuticals (NASDAQ: SNDX) presented clinical data for Revuforj (revumenib) across multiple acute leukemia subtypes at the European Hematology Association 2026 Congress. The company submitted 12 abstracts focused on the FDA-approved menin inhibitor.
A real-world study called ROAR showed an 82% overall response rate and 64% complete remission rate among 11 patients with relapsed/refractory NPM1 mutated or KMT2A-rearranged acute leukemia treated with revumenib monotherapy or combinations.
In a Phase 1 trial combining revumenib with intensive chemotherapy for newly diagnosed patients, 97% achieved composite complete remission and 86% showed measurable residual disease negativity among responders. The trial included 35 patients with NPM1 mutated or KMT2A-rearranged acute myeloid leukemia.
A post-hoc analysis from the AUGMENT-101 trial examined 19 patients who resumed revumenib after hematopoietic stem cell transplant. The analysis showed a 95% observed one-year overall survival rate.
The Phase 2 SAVE trial tested revumenib combined with venetoclax and decitabine/cedazuridine in relapsed/refractory patients. Among 42 patients with NPM1 mutated, KMT2A-rearranged, or NUP98-rearranged acute myeloid leukemia, the combination achieved an 88% overall response rate and 45% transplant rate.
For patients with NUP98-rearranged acute leukemia, a subtype with poor prognosis, revumenib showed a 28% overall response rate among 25 heavily pretreated patients in Phase 1 trials and expanded access programs.
"The breadth of data presented at EHA highlights physicians' enthusiasm for revumenib," said Nick Botwood, Head of Research & Development and Chief Medical Officer at Syndax, according to the company's press release.
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