- Article
- Source: Campus Sanofi
- 23 Oct 2023
Study Summary
![Guitar man](https://pro.campus.sanofi/.imaging/mte/portal/3840/dam/Portal/UK/Articles/Transplant/guitar-man.png/jcr:content/guitar-man.jpg)
![Insulin Trurapi (Insulin aspart 100 units/mL)](https://pro.campus.sanofi/.imaging/mte/portal/3840/dam/Portal/UK/Articles/Rezurock-hero.png/jcr:content/Rezurock%20hero.png)
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.
![](https://pro.campus.sanofi/dam/jcr:115963bb-06f8-4c6a-a8ad-5361cfd0a300/check.2022-11-03-12-25-13%20(1).png)
Clinically meaningful and statistically significant ORR of 74% (95% CI, 62-84)1
![](https://pro.campus.sanofi/dam/jcr:115963bb-06f8-4c6a-a8ad-5361cfd0a300/check.2022-11-03-12-25-13%20(1).png)
Responses across all evaluated organs, including those with fibrotic manifestations1,4
![](https://pro.campus.sanofi/dam/jcr:115963bb-06f8-4c6a-a8ad-5361cfd0a300/check.2022-11-03-12-25-13%20(1).png)
Median time to response was 4.4 weeks (3.7-40.6)3
![](https://pro.campus.sanofi/dam/jcr:115963bb-06f8-4c6a-a8ad-5361cfd0a300/check.2022-11-03-12-25-13%20(1).png)
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.
REZUROCK
Get the latest updates about REZUROCK.
This is intended for HCPs practising in Great Britain (England, Scotland, Wales) only.
![](https://pro.campus.sanofi/.imaging/mte/portal/3840/dam/Portal/UK/Articles/updated-Rezurock-Black-Traingle.jpg0/jcr:content/updated%20Rezurock%20Black%20Traingle.jpg)
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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