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Information Full Prescribing
Information

REZUROCK (belumosudil) tablets logo REZUROCK (belumosudil) tablets logo

THE ROCKstar STUDY

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The ROCKstar (KD025-213) study

REZUROCK demonstrated significant efficacy in patients after failure of ≥2 prior lines of systemic therapy1

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REZUROCK achieved clinically meaningful and statistically significant ORR with the FDA-approved dose of 200 mg once daily1

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Clinically meaningful responses were achieved across all affected organs, even those with fibrotic manifestations2

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CR, with the 200-mg once-daily dose, was achieved in all affected organ systems2

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Clinically significant FFS and OS rates3

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Clinically meaningful improvements (≥7-point reduction) in LSS summary score from baseline were observed, showing an increase in patient functioning and well-being1

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CS reductions and discontinuations were observed in 64% and 20% of patients, respectively2

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CNI reductions and discontinuations were observed in 42% and 17% of patients, respectively3

STATISTICALLY SIGNIFICANT ORRa FOLLOWING TREATMENT WITH REZUROCK 200 mg ONCE DAILY1,4,5

bar graph of overall response rate (ORR), 75%, with REZUROCK 200 mg once daily bar graph of overall response rate (ORR), 75%, with REZUROCK 200 mg once daily

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

REZUROCK ALSO DEMONSTRATED CLINICALLY MEANINGFUL ORRs ACROSS KEY SUBGROUPS IN THE 200-mg ONCE-DAILY ARM3

EARLYd cGVHD DIAGNOSIS

89%

(n/N=32/36)

SEVERE cGVHD

76%

(n/N=35/46)

cGVHD INVOLVING ≥4 ORGANS

73%

(n/N=24/33)

>3 PRIOR LINES OF SYSTEMIC THERAPY

70%

(n/N=21/30)

REFRACTORY TO THEIR PRIOR LINE OF SYSTEMIC THERAPY

75%

(n/N=9/12)

PRIOR IBRUTINIB THERAPY

73%

(n/N=16/22)

PRIOR RUXOLITINIB THERAPY

65%

(n/N=13/20)

dEarly diagnosis was defined as <28 months from time of initial diagnosis to enrollment.3

RESPONSES BY ORGAN SYSTEM WITH REZUROCK 200 mg ONCE DAILY IN THE mITT POPULATION (N=66)3

bar graph of complete and partial responses (CR and PR) by organ system in modified intent-to-treat (mITT) responders, including the upper GI tract, esophagus, lower GI tract, mouth, joints/fascia, liver, skin, eyes and lungs
bar graph of complete and partial responses (CR and PR) by organ system in modified intent-to-treat (mITT) responders, including the upper GI tract, esophagus, lower GI tract, mouth, joints/fascia, liver, skin, eyes and lungs

CR was seen in all organs, including the lungs, skin, eyes and liver.2

Responses were observed across all affected organs, even those with fibrotic manifestations.2

Clinically significant responses across multiple measures2

graphic showing the time to response was as early as 4 weeks, 63% of responses were observed between weeks 4 and 8, 94% of responses were observed by week 24, approximately 61% of responders demonstrated a sustained response for 20 or more weeks, and there was no death or new systemic therapy initiation in 62% (95% CI, 46-74) of the responder population at 12 months graphic showing the time to response was as early as 4 weeks, 63% of responses were observed between weeks 4 and 8, 94% of responses were observed by week 24, approximately 61% of responders demonstrated a sustained response for 20 or more weeks, and there was no death or new systemic therapy initiation in 62% (95% CI, 46-74) of the responder population at 12 months

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).

FFS3,e,h

graph showing the FFS rate was 73% at 6 months and 57% at 12 months graph showing the FFS rate was 73% at 6 months and 57% at 12 months graph showing the FFS rate was 73% at 6 months and 57% at 12 months

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

OS3,e,i

graph showing the 2-year OS rate was 89% graph showing the 2-year OS rate was 89%

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

LSS SUMMARY score: RATE OF clinically meaningful improvement (≥7-point reduction)1

52%

OF PATIENTSj

(95 CI, 40-65)

Clinically meaningful improvements (≥7-point reduction) in LSSe,k summary score were observed from baseline, showing an increase in patient functioning and well-being.1

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

CS DOSE reductions and discontinuations2,e

Doses were
reduced in

64%

of patients.

THE MEAN Dose
was reduced by

43%

in patients.

A mean CS dose reduction of 49% was observed in responders.

Treatment was discontinued in

20%

of patients.

CNI DOSE reductions and discontinuations3,e

Doses were
reduced in

42%

of patients.

Treatment was
discontinued in

17%

of patients.

ePrespecified secondary end point; not powered to show statistical significance.

TOLERABILITY IS KEY

in allowing patients to realize the full benefit of therapy.7

SEE THE SAFETY PROFILE FOR REZUROCK

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