- Article
- Source: Campus Sanofi
- 23 Oct 2023
Study Summary
This is intended for HCPs practising in Great Britain (England, Scotland, Wales) only.
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 (n=66) 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.
Clinically meaningful and statistically significant ORR of 74% (95% CI, 62-84)1
Responses across all evaluated organs, including those with fibrotic manifestations1,4
Median time to response was 4.4 weeks (3.7-40.6)3
FFSa rate at 6 (73%) and 12 (57%) months and estimated OSb (84%) rate at 24 months1,2
aFFS was defined as the absence of relapse, nonrelapse mortality or a need for additional systemic therapy.1
bOS was defined as the time from the first dose of REZUROCK to the date of death due to any cause.2
ORR, overall response rate; CR, complete response; PR, partial response; FFS, failure free survival; OS, overall survival.
References
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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
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Data on File. Sanofi
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REZUROCK. Summary of Product Characteristics
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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 (v6.0) Date of Preparation: October 2023