Efficacy and safety of belumosudil for heavily pretreated cGvHD: Update from the German-Austrian MAP

During the 52nd Annual Meeting of the European Society for Blood and Marrow Transplantation, March 22–25, 2026, Madrid, ES, Udo Holtick presented updated findings from a retrospective, multicenter analysis of adults with chronic graft-versus-host disease (cGvHD) who received belumosudil within a German and Austrian managed-access program (MAP; N = 144). The cohort had received a median of four prior lines of therapy (LoT), including ruxolitinib if not contraindicated, and 93% of patients were refractory to the previous treatment line. At belumosudil initiation, 72% of patients presented with severe cGvHD and had a median of three National Institutes of Health (NIH)-defined organ manifestations.

Key data: The best objective response rate (ORR) was 60% (complete remission [CR], 6%; partial remission [PR], 54%), with ORRs of 37%, 55%, 56%, and 56% at 1, 3, 6, and 12 months, respectively. At 6 months, 35% of patients discontinued steroid treatment and 33% reduced steroid dose by a median of 50%. Median time to response was 3.1 months. The 6- and 12‑month failure-free survival (FFS) rates were 81.9% and 68.0%, respectively, and corresponding overall survival (OS) rates were 96.9% and 90.7%. Grade 3/4 treatment-emergent adverse events (TEAEs), as defined by Common Terminology Criteria for Adverse Events (CTCAE), were mainly infectious events (n = 34), most commonly respiratory infection/pneumonia (n = 20).

Key learning: This German and Austrian real-world experience supports belumosudil as an efficacious and well-tolerated treatment option in patients with heavily pretreated cGvHD.