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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)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.

  1. Data on Sanofi file, mini-CVD, Final Draft_without naïve comparison section_clean, Phase 2 ROCKstar data cutoff September 2022.
  2. 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