Syndax revumenib meets primary endpoint in pivotal AUGMENT-101 trial; CR/CRh 23% (p=0.0036)

Syndax Pharmaceuticals Inc

Primary endpoint met with CR/CRh 23% (13/57) in pooled KMT2Ar acute leukemia; p=0.0036.
65% overall response rate in KMT2Ar AML; 50% of transplanted patients received post-transplant revumenib.
Median duration of CR/CRh 6.4 months; 46% still in remission as of July 24, 2023.
Favorable safety: only 6% discontinued due to TRAEs; no discontinuations for DS or QTc prolongation.
Company to submit NDA for revumenib to FDA by year-end; funded into 2025.

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