Real-world outcomes with belumosudil for treatment-refractory cGvHD: A Spanish multicenter experience

Results from a retrospective, Spanish multicenter study, evaluating real-world outcomes with belumosudil in patients with treatment-refractory chronic graft-versus-host disease (cGvHD) after ≥2 prior lines of therapy (LoT; N = 86), were recently published in Transplantation and Cellular Therapy by Bailén et al. Response rates, durability, and safety were evaluated. 

Key data: At belumosudil initiation, patients had received a median of four prior LoT and 91% had severe cGvHD. In response-evaluable patients (n = 72), the overall response rate (ORR) was 64% (complete response [CR], 7%; partial response [PR], 57%). Median time to response (TTR) was 3 months (range, 3–12) and median duration of response (DoR) was 12.8 months (95% confidence interval [CI], 10–15.6). The estimated median failure-free survival (FFS) was 18.9 months (95% CI, 16.7–21.2). At a median follow-up of 9 months, 20% of patients discontinued treatment, predominantly due to cGvHD progression, lack of efficacy (47%), or suspected adverse events (AEs; 24%).

Key learning: This Spanish real-world experience confirms the durable efficacy and manageable safety profile of belumosudil in heavily pretreated patients with predominantly severe cGvHD, supporting its use as third-line or subsequent therapy in this population.