Syndax reports positive pivotal data for revumenib and axatilimab; BLAs/NDAs expected by year-end 2023

Syndax Pharmaceuticals Inc

Axatilimab AGAVE-201 trial met primary endpoint: 74% ORR at 0.3 mg/kg every two weeks in refractory chronic GVHD; BLA submission planned by year-end 2023.
Revumenib AUGMENT-101 pivotal trial met primary endpoint: CR/CRh rate 23% in R/R KMT2Ar acute leukemia; NDA submission planned by year-end 2023.
Combination data showed 100% CRc with revumenib + venetoclax/azacitidine in newly diagnosed mNPM1 or KMT2Ar AML (BEAT AML trial).
SAVE AML trial all-oral combination achieved 78% CRc in R/R AML; AUGMENT-102 pediatric trial achieved 33% CRc with fludarabine-cytarabine.
Median OS for revumenib monotherapy in AUGMENT-101 was 8.0 months; 68% of CRc responders achieved MRD negativity.

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