Summary

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• This summary is based on the review of two randomized controlled trial(s). ^[1-2]
• Overall Response Rate (ORR): Belumosudil showed a high ORR across studies, with one study reporting an ORR of 73.3% (95% CI (95% CI, 65-87): 54.1-87.7%) and another reporting ORRs of 74% (95% CI, 62-84) for 200 mg daily and 77% (95% CI, 65-87) for 200 mg twice daily, with all responders achieving partial responses.
• Duration of Response (DOR) and Symptom Reduction: The median DOR was not reached in one study, while another reported a median DOR of 54 weeks. Additionally, 50% of patients in one study achieved significant symptom reduction, and 59%-62% of patients in another study saw meaningful improvements in symptoms with different dosing regimens of belumosudil.
• Time to Response (TTR) and Corticosteroid Reduction: The median TTR in one study was 4.3 weeks. Corticosteroid dose reductions were observed in 56.7% of patients, further supporting the drug’s effectiveness in reducing the need for additional immunosuppressive therapy.
• Treatment-Emergent Adverse Events (TEAEs): In one study, 36.7% of patients experienced grade ≥ 3 TEAEs, with pneumonia being the most common severe event (16.7%). In another study, 12% of subjects discontinued belumosudil due to possible drug-related adverse events.
• General Safety Profile: TEAEs reported in both studies were consistent with expectations for patients with chronic graft-versus-host disease (cGVHD) receiving corticosteroids and immunosuppressants. Most adverse events were mild to moderate in severity.
• The population in one study consisted of chronic graft-versus-host disease (cGVHD) patients in China who had been treated with at least one line of systemic therapy, showing a high ORR and meaningful symptom reduction. Another study included subjects with cGVHD who had received 2 to 5 prior lines of therapy, with high response rates observed across all subgroups, though specific subgroups were not detailed.