Kadmon's KD025 met primary endpoint in interim pivotal trial analysis of KD025
Kadmon Holding announced positive topline results from the planned interim analysis of ROCKstar KD025-213, the fully enrolled pivotal trial evaluating KD025 in patients with chronic graft-versus-host disease, or cGVHD, who have received at least two prior lines of systemic therapy. The trial met the primary endpoint of Overall Response Rate at the interim analysis, which was conducted as scheduled two months after completion of enrollment. KD025 has been well tolerated and adverse events have been consistent with those expected in the patient population. While the ORR endpoint was met at the interim analysis, the primary analysis of the KD025-213 study will occur in the first quarter of 2020, six months after completion of enrollment. This analysis will include updated safety data and efficacy data, including ORRs and secondary endpoints, such as duration of response, changes in corticosteroid dose and changes in quality of life. Kadmon plans to submit results from the KD025-213 study for presentation at an upcoming scientific meeting.