- Article
- Source: Campus Sanofi
- Jul 9, 2025
Rezurock Safety
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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)1
| 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
RWE2
| 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 (rate2) | 17 (13.5) | 67 (19.7) |
| Severe, n (rate2) | 30 (23.8) | 80 (23.5) |
| AE attributed to background cGVHD medication, n (rate2) | 12 (9.5) | 47 (13.8) |
| AE led to death, n (rate2) | 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.
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Data on Sanofi file, mini-CVD, Final Draft_without naïve comparison section_clean, Phase 2 ROCKstar data cutoff September 2022.
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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 Lazaryan2*, Mark van der Laan3,4, Catherine J. Lee5, Aaron C. Logan6, Susan Gruber3, Shaum Kabadi7, Irfan Khan7, Charlie Nicholls8, Lauren Rota7, Enkeleida Nikai9, Ekaterina Ponomareva10, Alexandra Koumas10, Edmund K. Waller1
MAT-KW-2500349