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Incyte and Syndax Announce New England Journal of Medicine Publication of Data from Pivotal AGAVE-201 Trial of Niktimvo™ (axatilimab-csfr) in Chronic Graft-Versus-Host Disease
– Trial met its primary endpoint across all dose cohorts with 74% of patients at the 0.3 mg/kg every 2 weeks dose achieving a complete or partial response
About this update from Syndax Pharmaceuticals, Inc.
[{"type":"text","content":"– Trial met its primary endpoint across all dose cohorts with 74% of patients at the 0.3 mg/kg every 2 weeks dose achieving a complete or partial response within the first six months of treatment –\n– Niktimvo approved by U.S. FDA for the treatment of chronic graft-versus-host disease after failure of at least two prior lines of systemic therapy in adult and pediatric patients weighing at least 40 kg –\n– Niktimvo added to latest NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for the treatment of chronic GVHD –\nWILMINGTON, Del. and WALTHAM, Mass., Sept. 18, 2024 /PRNewswire/ -- Incyte (Nasdaq:INCY) and Syndax Pharmaceuticals (Nasdaq:SNDX) today announced that results from the pivotal Phase 2 AGAVE-201 trial of Niktimvo™ (axatilimab-csfr), an anti-CSF-1R antibody, in adult and pediatric patients with recurrent/refractory active chronic graft-versus-host disease (GVHD) who had received at least two prior lines of systemic therapy were published in The New England Journal of Medicine.1 The publication, entitled \"Axatilimab in Recurrent or Refractory Chronic Graft-Versus-Host Disease\" can be found online here. \n\n\"Niktimvo is the first FDA approved treatment that targets the disease-modifying macrophages involved in both the fibrotic and inflammatory processes driving chronic GVHD,\" said Pablo J. Cagnoni, M.D., President and Head of Research and Development, Incyte. \"Following the launch of this new medicine, clinicians will be able to offer patients an agent that targets a distinct pathway and has demonstrated broad and durable responses in patients with chronic GVHD who progressed after at least two prior lines of therapy.\"\n\"The publication of the pivotal AGAVE-201 data in The New England Journal of Medicine underscores the importance of this dataset and the practice-changing potential of Niktimvo,\" said Neil Gallagher, M.D., Ph.D., President, Head of Research and Development at Syndax. \"Together with the Incyte team, we look forward to delivering this important new medicine to patients with chronic GVHD and exploring its potential application in earlier lines of chronic GVHD treatment and other diseases.\"\nThe AGAVE-201 pivotal trial enrolled 241 patients with recurrent or refractory chronic GVHD who had received two or more prior systemic therapies, with 74% having previously received ruxolitinib, ...