Rezurock Safety

Long term data on Rezurock demonstrates efficacy without compromising safety, establishing it as a well-tolerated 3L therapy for patients with cGVHD1 | ![]() |

Clinical Trial (ROCKstar 36-month follow-up)2
Category | Patients, n (%) (n=152*) |
Any AE | 151 (99) |
Grade ≥3 AEs | 94 (62) |
Drug-related AEs | 109 (72) |
Drug related SAEs, n(%) | 12 (8) |
On study death | 28 (18) |
AE leading to deaths | 10 (7) |
*152 patients include 77 patients on belumosudil 200 mg QD treatment and 75 patients on belumosudil 200 mg BID treatment
RWE3

Category | belumosudil LOT-episodes (n=113) | BAT LOT-episodes (n=245) |
Patients, n (ratea) | Patients, n (ratea) | |
Any AE | 52 (41.2) | 175 (51.3) |
Moderate, n (rate3) | 17 (13.5) | 67 (19.7) |
Severe, n (rate3) | 30 (23.8) | 80 (23.5) |
AE attributed to background cGVHD medication, n (rate3) | 12 (9.5) | 47 (13.8) |
AE led to death, n (rate3) | 5 (16) | 11 (16) |
a: Rate is the incidence rate per 100 episode-years (rate = count / ( total exposure time in years / 100))
Abbreviations
3L: Third line; AE: Adverse event; QoL: Quality of life; RWE: Real-world evidence; n: Sample size; LOT: Line of therapy; BAT: Best available therapies; cGVHD: Chronic graft-versus-host disease.
- Cutler, C. S., Lee, S. J., Arai, S., Rotta, M., Zoghi, B., Lazaryan, A., et al. (2024). Belumosudil for chronic graft-versus-host disease after 2 or more prior lines of therapy: Long-term follow-up from the ROCKstar trial. Bone Marrow Transplantation, 60, 439–446. https://doi.org/10.1038/s41409-024-02507-9
- Data on Sanofi file, mini-CVD, Final Draft_without naïve comparison section_clean, Phase 2 ROCKstar data cutoff September 2022.
- Data on Sanofi file, RockReal CSR, July 18 2024 / EBMT 2025 presentation Efficacy and Safety of Belumosudil as Compared with Best Available Therapy for the Treatment of cGVHD in the US - Kevin Hall1*, Dr. Aleksandr Lazaryan3*, Mark van der Laan4,5, Catherine J. Lee6, Aaron C. Logan7, Susan Gruber4, Shaum Kabadi8, Irfan Khan8, Charlie Nicholls9, Lauren Rota8, Enkeleida Nikai10, Ekaterina Ponomareva11, Alexandra Koumas11, Edmund K. Waller2