Belumosudil in cGVHD

Chronic GVHD (cGVHD) is a common complication following hematopoietic cell transplantation (HCT). In cGVHD, transplanted immune cells (graft) attack the patient’s cells (host), leading to inflammation and fibrosis in multiple tissues. Approximately 14,000 patients in the United States are living with cGVHD, and approximately 5,000 new patients are diagnosed with cGVHD per year[1].

Belumosudil has demonstrated clinical activity and generally was well tolerated in a Phase 2a trial in cGVHD (KD025-208). Enrollment is complete in ROCKstar (KD025-213), a pivotal clinical trial of belumosudil in adults and adolescents with cGVHD who have received at least two prior lines of systemic therapy. In November 2019, we announced that belumosudil met the primary endpoint at the planned interim analysis of ROCKstar.  The FDA has granted Breakthrough Therapy Designation to belumosudil for the treatment of cGVHD after at least two prior lines of systemic therapy. The FDA has also granted Orphan Drug Designation to belumosudil for the treatment of cGVHD. Belumosudil is being reviewed under the FDA’s Real-Time Oncology Review (RTOR) Pilot Program.

[1] Bachier, CR. et al. ASH Annual Meeting 2019, Abstract #2109. Epidemiology and Real-World Treatment of Chronic Graft-Versus-Host Disease Post Allogeneic Hematopoietic Cell Transplantation: A U.S. Claims Analysis.

cGVHD: Inflammation and Fibrosis in Multiple Organs

Anatomy Diagram