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Syndax Announces Results from the Pivotal AGAVE-201 Trial of Axatilimab in Chronic Graft-Versus-Host Disease to Be Featured in Plenary Session at the 65th ASH Annual Meeting
– Results support axatilimab's promising safety and efficacy profile, and reinforce its potential as a first-in-class CSF-1R monoclonal antibody in chronic
About this update from Syndax Pharmaceuticals, Inc.
[{"type":"text","content":"– Results support axatilimab's promising safety and efficacy profile, and reinforce its potential as a first-in-class CSF-1R monoclonal antibody in chronic graft-versus-host disease –\n– Syndax and Incyte intend to file a Biologics License Application (BLA) by year-end 2023 –\nWALTHAM, Mass., Nov. 2, 2023 /PRNewswire/ -- Syndax Pharmaceuticals (Nasdaq: SNDX), a clinical-stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today announced that results from the pivotal AGAVE-201 trial of axatilimab, an anti-CSF-1R antibody, in adult and pediatric patients with chronic graft-versus-host disease (cGVHD), will be featured during the Plenary Scientific Session at the 65th American Society of Hematology (ASH) Annual Meeting being held December 9-12, 2023, in San Diego, California.\n\n\"Inclusion of AGAVE-201 in this year's ASH plenary session further supports our belief that axatilimab has the potential to serve as a highly differentiated therapeutic option for patients with chronic GVHD,\" said Michael A. Metzger, Chief Executive Officer. \"We believe axatilimab's best-in-category profile and unique mechanism of action positions it as an important addition to the chronic GVHD treatment armamentarium, if approved. We look forward to sharing the full dataset next month.\" \nThe Company and its partner, Incyte, previously announced positive topline data from the pivotal AGAVE-201 trial of axatilimab in patients with cGVHD following two or more prior lines of therapy. All three dose cohorts, 0.3 mg/kg every two weeks, 1.0 mg/kg every two weeks, and 3.0 mg/kg every four weeks, met the primary endpoint. The overall response rate within the first six months of treatment at the 0.3 mg/kg dose was 74%, and 60% of these patients were still responding at one year. Furthermore, axatilimab was generally well tolerated, and the most common adverse events were consistent with on-target effects and prior trials. Syndax and Incyte expect to submit a BLA filing by year-end 2023.\nAbstract Number: 1Title: Safety and Efficacy of Axatilimab at 3 Different Doses in Patients with Chronic Graft-Versus-Host Disease (AGAVE-201)Presenter: Daniel Wolff, M.D.Session Name: Plenary Scientific SessionSession Date: Sunday, December 10, 2023Session Time: 2:00 – 4:00 PM PTPresentation Time: 2:00 PM PT\nAxatilimab Preclinical Data\nIn a...