Dr. Cutler on the Results of the ROCKstar Study 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 results of the ROCKstar study in chronic graft-versus-host disease (cGVHD).

The open-label, randomized, multicenter, phase 2 ROCKstar study evaluated the efficacy of belumosudil (KD025)​, an investigational oral selective rho-associated coiled-coil kinase 2 (ROCK2) inhibitor, given at 200 mg once or twice daily in patients with cGVHD who received 2 to 5 prior lines of therapy.

Patients were stratified based on number of prior lines of therapy ​and number of ​involved organs, says Cutler. Notably, 67% of patients had severe cGVHD, ​and 52% ​of patients had 4 or more organs involved. ​Additionally, 72% ​of patients received ​at least 3 prior lines of therapy, and 73% were refractory to their last line of therapy.

At a median follow up of 8 months, the overall response rate (ORR) was 73% among patients who received 200 mg of belumosudil once daily and 74% in the patients who received 200 mg of belumosudil twice daily. In the 29% of patients who previously received ruxolitinib (Jakafi), the ORR​s with 200 mg of belumosudil once and twice daily were 65% and 72%​, respectively. Moreover, in the 35% of patients who previously received ibrutinib (Imbruvica), the ORR​s with 200 mg of belumosudil once and twice daily were 73% and 71%​, respectively.