Kadmon Holdings claimed positive results from ongoing Phase 2 Clinical trial KD025-208 assessing updated optimistic results from an ongoing Phase 2 Clinical Trial KD025-208 evaluating KD025, its Rho-associated coiled-coil kinase 2 (ROCK2) inhibitor, in patients with chronic graft-versus-host disease (cGVHD).
Aleksandr Lazaryan, M.D., MPH, Ph.D., Assistant Professor of Medicine, Division of Hematology, Oncology and Transplantation, University of Minnesota and study investigator said “KD025 was also well tolerated, and many patients have been able to reduce or discontinue steroids and other immunosuppressants, thereby helping to avoid their adverse effects and improve patients’ quality of life.”
The data demonstrated Overall Response Rate (ORR) of 69%, as of a data cutoff date of January 3, 2018. Responses in Cohort 1 (KD025 200 mg QD; n=17) remained the same, showing an ORR of 65%. Responses were rapid, with approximately 70% of patients across Cohorts 1 and 2 achieving responses by the first assessment (after 8 weeks of treatment). Responses were observed across all affected organs, including in organs with fibrotic manifestations of the disease such as lungs, eyes, skin and joints. In responders with 4 or more organs involved, 6/13 (46%) showed responses in 4 or more organs. In addition, 64% of patients were able to reduce steroid dose, and four patients completely discontinued steroid use.