Kadmon fully enrolls KD025 trial for cGVHD
Kadmon Holdings announced that KD025-213, an open-label registration trial of KD025 for the treatment of chronic graft-versus-host disease, is fully enrolled. The study is being conducted at more than 30 clinical sites throughout the United States. The company expects to disclose outcomes from a planned interim analysis before year end. Data from this analysis are intended to serve as the basis for a pre-New Drug Application meeting with the U.S. FDA regarding KD025 in cGVHD. KD025-213 is an open-label registration trial of KD025 in adults and adolescents with cGVHD who have received at least two prior lines of systemic therapy. Patients were randomized to receive KD025 200 mg QD or 200 mg BID, enrolling 63 patients per arm. The primary endpoint is the Overall Response Rate, defined as the percentage of patients who achieve a complete or partial response at any time point during the study, per the 2014 National Institutes of Health overall response criteria. Based on FDA guidance, an ORR of greater than or equal to30% is considered clinically significant. The KD025-213 study protocol is based on FDA guidance received in a Type C meeting and was designed in consultation with leading cGVHD experts. The FDA has granted Breakthrough Therapy Designation to KD025 for the treatment of cGVHD following at least 2 prior systemic therapies. The FDA has also granted Orphan Drug Designation to KD025 for the treatment of cGVHD.