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Syndax Announces Completion of Enrollment in AUGMENT-101 Pivotal Trial Cohort of Patients with Relapsed/Refractory mNPM1 Acute Myeloid Leukemia
– Topline data expected in 4Q24 could support sNDA filing in 1H25 – – Revumenib has the potential to address $2 billion mNPM1 and KMT2Ar R/R acute leukemia
About this update from Syndax Pharmaceuticals, Inc.
[{"type":"text","content":"– Topline data expected in 4Q24 could support sNDA filing in 1H25 –\n– Revumenib has the potential to address $2 billion mNPM1 and KMT2Ar R/R acute leukemia U.S. market opportunity –\nWALTHAM, Mass., March 28, 2024 /PRNewswire/ -- Syndax Pharmaceuticals (Nasdaq: SNDX), a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today announced completion of enrollment in the AUGMENT-101 pivotal trial cohort of patients with relapsed/refractory (R/R) mutant nucleophosmin (mNPM1) acute myeloid leukemia (AML). Topline data is expected in the fourth quarter of 2024 and could support a supplemental New Drug Application (sNDA) filing for revumenib in R/R mNPM1 AML in the first half of 2025.\n\n\"We are thrilled to announce that we are one step closer to potentially expanding the therapeutic reach of revumenib in genetically defined acute leukemias,\" said Neil Gallagher, M.D., Ph.D., President, Head of Research and Development at Syndax. \"We look forward to reporting topline data for this pivotal cohort in the fourth quarter of this year, which will follow closely behind a potential first approval of KMT2A acute leukemia in the third quarter.\"\nMichael A. Metzger, Chief Executive Officer, added, \"With revumenib and axatilimab, two first-and best-in-class drugs, expected to launch in 2024 and the potential to expand beyond first approvals and into additional indications, Syndax is well positioned to deliver on its mission to improve the lives of cancer patients and create meaningful long-term value for shareholders.\"\nSixty-four (64) adult and up to 20 pediatric patients with mNPM1 AML have been enrolled into the pivotal portion of AUGMENT-101, a pivotal trial designed to evaluate the safety, tolerability, pharmacokinetics, and efficacy of orally administered revumenib. The primary endpoint for the trial is efficacy as measured by complete remission (CR) or a CR with partial hematological recovery (CRh) rate (CR + CRh) per protocol, with secondary endpoints including duration of response (DOR) and overall survival (OS).\nA new drug application (NDA) is under review by the U.S. Food and Drug Administration (FDA) for revumenib in R/R KMT2Ar acute leukemia with a Prescription Drug User Fee Act (PDUFA) action date of September 26, 2024. The NDA submission is supported by positive data from the AUGM...