Kadmon initiates Phase 2 KD025 trial in cGVHD
Kadmon Holdings announced that the first patient has been dosed in a pivotal clinical trial of KD025 in chronic graft-versus-host disease. The study will evaluate the efficacy and safety of KD025, Kadmon's ROCK2 inhibitor, in adults with cGVHD who have received at least two prior lines of systemic therapy. The trial is designed to support a filing for U.S. regulatory approval of KD025. ROCKstar is a Phase 2 open-label trial in which patients will be randomized to receive KD025 200 mg QD or KD025 200 mg BID, enrolling 63 patients per arm. Either KD025 dose may be considered by the U.S. Food and Drug Administration for the registrational dose. The primary endpoint is the Overall Response Rate (ORR), defined as the percentage of patients who meet the 2014 National Institutes of Health Consensus Conference overall response criteria of complete or partial response. The ROCKstar study protocol is based on FDA guidance received in a Type C meeting and was designed in consultation with leading cGVHD experts.