Syndax reports data from Phase 2 portion of AUGMENT-101 trial of revumenib

Syndax Pharmaceuticals announced that data from the pivotal Phase 2 portion of the AUGMENT-101 trial of revumenib, a first-in-class menin inhibitor, in adult and pediatric patients with relapsed/refractory, or R/R, KMT2A-rearranged, or KMT2Ar, acute myeloid leukemia, or AML, and acute lymphoid leukemia, or ALL, have been published in the Journal of Clinical Oncology. The FDA has granted Priority Review for the New Drug Application for revumenib for the treatment of adult and pediatric R/R KMT2Ar acute leukemia. The NDA is being reviewed under the FDA’s Real-Time Oncology Review Program and has a Prescription Drug User Fee Act target action date of December 26. In March 2024, the Company announced the completion of enrollment in the final AUGMENT-101 pivotal trial cohort in patients with R/R mutant nucleophosmin AML. Topline data is expected in the Q4 and could support a supplemental NDA filing for revumenib in R/R mNPM1 AML in the first half of 2025. The publication entitled “Menin Inhibition With Revumenib for KMT2A-Rearranged Relapsed or Refractory Acute Leukemia ” includes positive data from a total of 94 acute leukemia patients with KMT2Ar in the pivotal trial as of the July 2023 data cutoff, 57 of whom had central confirmation of their KMT2Ar status, sufficient follow-up and were in the efficacy analysis. The AUGMENT-101 trial met its primary endpoint at the protocol-defined interim analysis with a complete remission, or CR, or a CR with partial hematological recovery, or CRh, rate of 23% among the 57 efficacy evaluable patients in the KMT2Ar acute leukemia population. The CR + CRh rate was 23% in adult patients and 23% in pediatric patients.