Syndax to present new data on revumenib in leukemia

Syndax (SNDX) announced that multiple abstracts evaluating revumenib, an oral small molecule menin inhibitor, have been accepted for oral presentation at the 66th American Society of Hematology Annual Meeting in San Diego, December 7-10. The oral presentations will highlight data evaluating the safety and efficacy of revumenib as monotherapy or in combination for the treatment of patients with acute leukemias. New monotherapy and combination data in acute leukemia include: 64% ORR in expanded dataset of patients with R/R KMT2Ar acute leukemia in Ph 2 AUGMENT-101 pivotal cohort; 88% ORR ) in SAVE trial testing revumenib, venetoclax and decitabine/cedazuridine combination in R/R AML. The FDA has granted Priority Review for the New Drug Application for revumenib for the treatment of adult and pediatric patients with relapsed or refractory KMT2A-rearranged acute leukemia. The NDA is has a PDUFA target action date of December 26. In March, the company completed enrollment in the final AUGMENT-101 pivotal trial cohort in patients with R/R mutant nucleophosmin acute myeloid leukemia. Topline data is expected in Q4 2024 and could support a supplemental NDA filing for revumenib in R/R mNPM1 AML in the first half of 2025.