Belumosudil in Japanese patients with cGvHD: Results from a phase III trial

Results from a phase III trial of belumosudil as a second or subsequent line of therapy in Japanese patients aged ≥12 years with steroid-dependent/resistant chronic graft-versus-host disease (cGvHD) were presented during the European Hematology Association (EHA) 2024 Hybrid Congress by Onishi.¹ This analysis evaluated the safety and efficacy of belumosudil at 48 weeks after the last patient enrolment.¹

The best overall response rates at 24 weeks (primary efficacy endpoint) and 48 weeks after last patient enrolment were both 85.7%.

The median duration of response was 68.1 weeks, and the median failure-free survival and overall survival were not reached.

No new safety concerns were observed, and there were no drug-related discontinuations or deaths.

The high response rates and tolerable safety profile demonstrated in this trial support the use of belumosudil as a second or subsequent line of therapy in the treatment of Japanese patients aged ≥12 years with steroid-dependent/resistant cGvHD.