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Syndax Announces Publication in the Journal of Clinical Oncology of Data from the Pivotal AUGMENT-101 Trial of Revumenib in Relapsed/Refractory KMT2Ar Acute Leukemia
– Pivotal AUGMENT-101 trial met its primary endpoint at interim analysis of patients with KMT2Ar AML and ALL (p-value = 0.0036) – – NDA filing for revumenib
About this update from Syndax Pharmaceuticals, Inc.
[{"type":"text","content":"– Pivotal AUGMENT-101 trial met its primary endpoint at interim analysis of patients with KMT2Ar AML and ALL (p-value = 0.0036) –\n– NDA filing for revumenib in R/R KMT2Ar acute leukemia is being reviewed under RTOR; PDUFA action date of December 26, 2024 –\nWALTHAM, Mass., Aug. 12, 2024 /PRNewswire/ -- Syndax Pharmaceuticals (Nasdaq: SNDX), a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today 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 (R/R) KMT2A-rearranged (KMT2Ar) acute myeloid leukemia (AML) and acute lymphoid leukemia (ALL) have been published in the Journal of Clinical Oncology. \n\n\"Publication of the pivotal AUGMENT-101 dataset in KMT2Ar acute leukemia allows for a broader dissemination of these important data and highlights revumenib's impressive and consistent clinical profile that has led to meaningful results for these advanced patients,\" said Neil Gallagher, M.D., Ph.D., President, Head of Research and Development at Syndax. \"These data serve as the foundation for the NDA filing that is currently being reviewed by the FDA under its RTOR program. As we approach the potential FDA approval of revumenib, we are actively preparing for a successful commercial launch to enable us to deliver this important medicine to patients in need.\"\n\"Despite an increased understanding of the mechanisms governing development of KMT2Ar acute leukemia, no available therapies adequately serve this population,\" said Ghayas C. Issa, M.D., Assistant Professor, Department of Leukemia, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center. \"The high rate of deep, MRD negative responses along with a safety profile that supports prolonged time on therapy and maintained remission post-stem cell transplant gives me confidence that revumenib could serve as a paradigm-changing treatment.\"\nThe FDA has granted Priority Review for the New Drug Application (NDA) 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 (RTOR) and has a Prescription Drug User Fee Act (PDUFA) target action date of December 26, 2024. \nIn March 2024, the ...