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Campus
  1. Article
  2. Source: Campus Sanofi
  3. 1 Sept 2024
2 min

Study Summary

Author: Sanofi

Editorial Team

REZUROCK®▼(belumosudil)
Guitar man
Insulin Trurapi (Insulin aspart 100 units/mL)

This is intended for HCPs practising in Great Britain (England, Scotland, Wales) only.

Prescribing Information (GB 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 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 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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REZUROCK

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Safety Profile

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This is intended for HCPs practising Great Britain (England, Scotland, Wales) only​.

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