Dr. Cutler on the Toxicity Profile of Belumosudil in cGVHD

Corey S. Cutler, MD, MPH, FRCPC, medical director, Adult Stem Cell Transplantation Program, director of Clinical Research, Stem Cell Transplantation, director, Stem Cell Transplantation Survivorship Program, institute physician, Dana-Farber Cancer Institute, and associate professor of medicine, Harvard Medical School, discusses the toxicity profile of belumosudil (KD025) in patients with chronic graft-versus-host disease (cGVHD).

Data from the ongoing phase 2 ROCKstar trial (NCT03640481), which were presented virtually during the 47th Annual Meeting of the EBMT, demonstrated an overall response rate of 73% with once-daily belumosudil vs 77% with twice-daily belumosudil in patients with cGVHD. 

Regarding safety, the adverse effects with belumosudil were consistent with those expected in patients with cGVHD receiving corticosteroids and other immunosuppressants, says Cutler. Overall, grade 3 or greater toxicities were infrequent and included pneumonia, hypertension, and hyperglycemia, Cutler explains. Eight patients died while on study because of aspiration pneumonia, hemoptysis, multiple organ dysfunction syndrome/septic shock, relapse acute myeloid leukemia, cardiac arrest, infection, and respiratory failure. However, few patients had to discontinue treatment because of toxicity, Cutler says.

Despite the incidence of relapse AML, these findings do not suggest that belumosudil is immunosuppressive enough to cause a high rate of relapse among patients treated, concludes Cutler.