Ashland(US:ASH) Prnewswire·2024-11-05 14:00Core Insights - Syndax Pharmaceuticals announced that multiple abstracts evaluating Niktimvo™ (axatilimab-csfr) for chronic graft-versus-host disease (GVHD) will be presented at the 66th American Society of Hematology (ASH) Annual Meeting [1][3] Group 1: Clinical Trial Results - The pivotal Phase 2 AGAVE-201 trial of Niktimvo showed a 75% overall response rate (ORR) among patients receiving the approved dose of 0.3 mg/kg every two weeks [4] - An estimated 60% of patients who responded maintained their response at 12 months [4] - More than half of responders in the 0.3 mg/kg cohort had an overall clinical response by day 56 of treatment [5] Group 2: Mechanism of Action and Safety - Preclinical data will be presented detailing the anti-inflammatory and anti-fibrotic mechanisms of axatilimab in chronic GVHD [8] - The exposure-efficacy analysis indicated that lower axatilimab exposure increased the odds of response, while higher exposure was associated with increased treatment-emergent adverse events [7] Group 3: Upcoming Presentations - An oral presentation titled "Dynamics of Overall and Organ-Specific Responses to Axatilimab in Chronic Graft-Versus-Host Disease" will take place on December 7, 2024 [6] - A poster presentation on "Exposure-Response Relationships for Axatilimab" is scheduled for the same day [8] Group 4: Company Collaboration and Future Directions - Syndax is collaborating with Incyte to advance the clinical development of Niktimvo for chronic GVHD and other inflammatory diseases [3] - The company is also exploring the use of axatilimab in combination with other therapies for chronic GVHD and idiopathic pulmonary fibrosis [13]