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
MAT-KW-2500349
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