Syndax’s axatilimab shows safety and efficacy in graft-versus-host disease

Syndax 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 Annual Meeting December 9-12 in San Diego. The 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 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.