Important Safety
Information
Full Prescribing
Information
REZUROCK achieved clinically meaningful and statistically significant ORR with the FDA-approved dose of 200 mg once daily1
Clinically meaningful responses were achieved across all affected organs, even those with fibrotic manifestations2
CR, with the 200-mg once-daily dose, was achieved in all affected organ systems2
Clinically significant FFS and OS rates3
Clinically meaningful improvements (≥7-point reduction) in LSS summary score from baseline were observed, showing an increase in patient functioning and well-being1
CS reductions and discontinuations were observed in 64% and 20% of patients, respectively2
CNI reductions and discontinuations were observed in 42% and 17% of patients, respectively3
aProportion of patients who achieved CR or PR according to the 2014 NIH cGVHD Consensus Criteria.1
bThe final FDA interpretation of the ROCKstar study omitted 1 patient from the REZUROCK 200-mg once-daily arm. As a result, there are minor differences between the ROCKstar publication, where n=66, and the Prescribing Information, where n=65.
cStatistical significance was achieved if the lower bound of the 95% CI of ORR exceeded 30%.4
(n/N=32/36)
(n/N=35/46)
(n/N=24/33)
(n/N=21/30)
(n/N=9/12)
(n/N=16/22)
(n/N=13/20)
dEarly diagnosis was defined as <28 months from time of initial diagnosis to enrollment.3
Responses were observed across all affected organs, even those with fibrotic manifestations.2
ePrespecified secondary end point; not powered to show statistical significance.
fThe responder population in the 200-mg once-daily arm was n=49.3
gBased on a final analysis by the FDA (n=65).
ePrespecified secondary end point; not powered to show statistical significance.
hFFS was defined as the absence of relapse, nonrelapse mortality or a need for additional systemic therapy.2
ePrespecified secondary end point; not powered to show statistical significance.
iOS was defined as the time from the first dose of REZUROCK to the date of death due to any cause.3
ePrespecified secondary end point; not powered to show statistical significance.
jBased on a final analysis by the FDA (n=65).
kThe LSS is a 30-item, 7-subscale symptom scale and QOL measurement tool that evaluates the AEs of cGVHD in the categories of skin, vitality, lung, nutritional status, psychological functioning, eye and mouth.6
of patients.
in patients.
of patients.
of patients.
of patients.
ePrespecified secondary end point; not powered to show statistical significance.
AE, adverse event; cGVHD, chronic graft-versus-host disease; CNI, calcineurin inhibitor; CR, complete response; CS, corticosteroid; DOR, duration of response; FDA, US Food and Drug Administration; FFS, failure-free survival; GI, gastrointestinal; LSS, Lee Symptom Scale; mITT, modified intent-to-treat; MOA, mechanism of action; ORR, overall response rate; OS, overall survival; PR, partial response.
References: 1. REZUROCK. Package insert. Kadmon Pharmaceuticals, LLC; 2021. 2. Cutler CS, Lee SJ, Arai S, et al. Belumosudil for chronic graft-versus-host disease (cGVHD) after 2 or more prior lines of therapy: the ROCKstar study. Blood. 2021;blood.2021012021. doi:10.1182/blood.2021012021. 3. Data on file 1. Kadmon Pharmaceuticals, LLC; 2021. 4. Data on file 2. Kadmon Pharmaceuticals, LLC; 2019. 5. Data on file. Kadmon Pharmaceuticals, LLC; 2021. 6. Lee SJ, Nguyen TD, Onstad L, et al. Success of immunosuppressive treatments in patients with chronic graft-versus-host disease. Biol Blood Marrow Transplant. 2018;24(3):555-562. doi:10.1016/j.bbmt.2017.10.042 7. Broadening the definition of tolerability in cancer clinical trials to better measure the patient experience. Friends of Cancer Research. Published October 24, 2018. Accessed July 27, 2021. https://www.focr.org/sites/default/files/Comparative Tolerability Whitepaper_FINAL.pdf