Syndax reports positive pivotal Phase 2 results for revumenib in R/R mNPM1 AML; CR/CRh 23%

Syndax Pharmaceuticals Inc

Primary endpoint met: CR/CRh rate 23% (15/64; 95% CI 14%–36%; p=0.0014) in efficacy-evaluable adult patients.
ORR 47% (30/64); 75% had prior venetoclax; 36% received ≥3 prior lines of therapy.
Safety profile consistent; 5% discontinued due to TRAEs. Grade ≥3 TRAEs: QTc prolongation 21%, anemia 14%, febrile neutropenia 13%, DS 13%, platelet count decreased 11%.
sNDA filing for R/R mNPM1 AML expected in 1H25; FDA decision on KMT2Ar acute leukemias expected in 4Q24.

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