Syndax’s revumenib meets primary results in AML trial

Syndax (SNDX) announced positive topline results from the relapsed or refractory mutant NPM1 – mNPM1 – acute myeloid leukemia, or AML, cohort in the pivotal Phase 2 portion of the AUGMENT-101 trial of revumenib, an oral, small molecule menin inhibitor. The primary endpoint was met with a complete remission, or CR, plus CR with partial hematological recovery rate of 23% among the efficacy evaluable adults with R/R mNPM1 AML in the Phase 2 portion of the AUGMENT-101 trial. Among the patients who achieved CR/CRh, 12 patients had a CR and three had a CRh. The observed median duration of CR/CRh responses was 4.7 months at data cutoff with three patients remaining in response. Overall response rate was 47%. 17% of patients who achieved an overall response underwent hematopoietic stem cell transplant following treatment with revumenib, with three resuming revumenib therapy post-transplant. The safety profile observed with revumenib in this population was consistent with previously reported data. Treatment-related adverse events leading to treatment discontinuations were 5%. Grade 3 treatment-related DS was observed in 11% of patients while 2% experienced Grade 4 DS and no patients experienced Grade 5.