SALT LAKE CITY – KD025, an orally available Rho-associated coiled-coil kinase 2–selective inhibitor, is demonstrating encouraging activity and safety in patients with steroid-dependent or refractory chronic graft-versus-host disease (cGVHD) in a phase 2a clinical trial.
Initial results from the ongoing open-label trial known as KD025-208 showed that 11 of 17 patients (65%) and 11 of 16 patients (69%) enrolled in 200-mg daily and 200-mg twice-daily dose cohorts, respectively, had a clinical response with no reported treatment-related serious adverse events at any evaluation time point, Aleksandr Lazaryan, MD, PhD, reported at the combined annual meetings of the Center for International Blood & Marrow Transplant Research and the American Society for Blood and Marrow Transplantation.
Although clinical response in this study was defined as complete response (CR) or partial response (PR), all patient responses were PRs, said Dr. Lazaryan of the University of Minnesota, Minneapolis.The median duration of treatment in the 200-mg daily group (cohort 1) was 37 weeks, and in the 200-mg twice-daily group (cohort 2) was 28 weeks. At last follow-up, eight patients remained active in each cohort, and these patients had a median treatment duration of 53 and 38 weeks, respectively, he said.