- Article
- Source: Campus Sanofi
- 1 Sept 2024
Study Summary
ROCKstar study
Responses with REZUROCK were seen after failure of ≥2 prior lines of therapy1
Study design1: ROCKstar was a pivotal phase 2, open label, non-controlled, randomized, multicenter study that evaluated the efficacy and safety of REZUROCK in patients with cGvHD after receiving 2 to 5 prior lines of systemic therapy.
Treatment consisted of REZUROCK 200 mg and was administered continuously until clinically significant progression of cGvHD or unacceptable toxicity.
Primary end point1: Best ORR at any time, defined as the proportion of subjects who achieved CR or PR according to the 2014 NIH cGVHD Consensus Criteria.
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Clinically meaningful and statistically significant best ORR of 74% (n=66, 95% CI, 62-84)2 at 1 year was maintained after 3 years of treatment with REZUROCK (n=77, 95% CI, 63-83)3.
Responses across all evaluated organs, including those with fibrotic manifestations1,4.
Median time to response to the initiation of new systemic cGVHD therapy was 100.3 weeks (54.14-NA)2.
Over 3 years, 65% (n/N=50/76) reduced their CS dose and 27% (n/N=21/73) discontinued CS therapy3
ORR, overall response rate; CR, complete response; CS, corticosteroids; PR, partial response; FFS, failure free survival; OS, overall survival.
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1 Cutler C, Lee SJ, Arai S, et al; on behalf of the ROCKstar Study Investigators. Belumosudil for chronic graft-versus-host disease after 2 or more prior lines of therapy: the ROCKstar Study. Blood. 2021;138(22):2278-2289. doi:10.1182/blood.2021012021
2 Data on File. Sanofi. 2023.
3 Data on File. Sanofi. 2024.
4 Cutler C, Lee SJ, Arai S, et al; on behalf of the ROCKstar Study Investigators. Belumosudil for chronic graft-versus-host disease after 2 or more prior lines of therapy: the ROCKstar Study. Blood. 2021;138(22):2278-2289. doi:10.1182/blood.2021012021. Supplementary Appendix.
MAT-XU-2204906 (v8.0) Date of Preparation: February 2025