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THE ROCKstar STUDY

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The ROCKstar (KD025-213) study

Clinically meaningful responses with REZUROCK were seen across all patient types after failure of ≥2 prior lines of therapy1,2

 

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Clinically meaningful and statistically significant ORRa in a real-world demographic of patients1

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Clinically meaningful ORRs observed across key subgroups2

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Responses across all evaluated organs, including those with fibrotic manifestations2

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Most responses were seen between 4 and 8 weeks3

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FFSb rate at 6 and 12 months and OSc rate at 24 months2,3

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Exploratory analyses of LSSd summary score showed clinically meaningful improvements (≥7-point reduction) in patient-reported QOL1

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Reduction in use of CS and CNI therapies2,3

aProportion of patients who achieved CR or PR according to the 2014 NIH cGVHD Consensus Criteria.1

bFFS was defined as the absence of relapse, nonrelapse mortality or a need for additional systemic therapy.2

cOS was defined as the time from the first dose of REZUROCK to the date of death due to any cause.3

dThe 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.4

STATISTICALLY SIGNIFICANT ORRa FOLLOWING TREATMENT WITH REZUROCK 200 mg ONCE DAILY1,5,6

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

CR, n=4 (6%). PR, n=45 (69%).1

 

aProportion of patients who achieved CR or PR according to the 2014 NIH cGVHD Consensus Criteria.1

eBased on a final analysis by the FDA (n=65).

fStatistical significance was achieved if the lower bound of the 95% CI of ORR exceeded 30%.5

CLINICALLY MEANINGFUL ORRs OBSERVED ACROSS KEY SUBGROUPS IN THE 200 mg ONCE-DAILY ARM3

EARLY cGVHD DIAGNOSIS

89%

Defined as <28 months from initial diagnosis.

(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
 

PRIOR RUXOLITINIB THERAPY

65%

(n/N=13/20)

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, including the upper GI tract, esophagus, lower GI tract, mouth, joints/fascia, liver, skin, eyes and lungs, with REZUROCK 200 mg once daily in the modified intent-to-treat (mITT) population
bar graph of complete and partial responses (CR and PR) by organ system, including the upper GI tract, esophagus, lower GI tract, mouth, joints/fascia, liver, skin, eyes and lungs, with REZUROCK 200 mg once daily in the modified intent-to-treat (mITT) population

CR was observed in all evaluated organs, including those with fibrotic manifestations, such as the lungs, skin, joints/fascia and the GI system.2

Most responses were seen between 4 and 8 weeks3

CUMULATIVE RESPONSE RATES OVER TIME IN THE RESPONDER
POPULATION WITH REZUROCK 200 mg ONCE DAILY (n/N=49/66)3

graphic showing the time to response was as early as 4 weeks (n/N=5/49), 63% of responses were observed between weeks 4 and 8, 94% of responses were observed by week 24 and the median time to response was 1.8 months (95% CI, 1.0-1.9) graphic showing the time to response was as early as 4 weeks (n/N=5/49), 63% of responses were observed between weeks 4 and 8, 94% of responses were observed by week 24 and the median time to response was 1.8 months (95% CI, 1.0-1.9)

62%

OF THE RESPONDER POPULATIONe

did not experience death or new systemic therapy initation (95% CI, 46-74) for ≥12 months after response.1

eBased on a final analysis by the FDA (n=65).

FFSb,g WITH REZUROCK 200 mg ONCE DAILY IN THE mITT POPULATION2,3

Kaplan-Meier graph showing the FFS rate with two box insets showing that 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

Kaplan-Meier curve of estimated FFS.

bFFS was defined as the absence of relapse, nonrelapse mortality or a need for additional systemic therapy.2

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

OSc,g WITH REZUROCK 200 mg ONCE DAILY IN THE mITT POPULATION3

Kaplan-Meier graph showing the 2-year OS rate with a box inset showing that the OS rate was was 87% Kaplan-Meier graph showing the 2-year OS rate with a box inset showing that the OS rate was was 87%

Kaplan-Meier curve of estimated OS.

cOS was defined as the time from the first dose of REZUROCK to the date of death due to any cause.3

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

CLINICALLY MEANINGFUL IMPROVEMENTS IN PATIENT-REPORTED QOL1,h

(≥7-point reduction in LSSd summary score) with REZUROCK 200 mg once daily in the mITT population in an exploratory analysis

52%

OF PATIENTSe REPORTED IMPROVEMENTS IN QOL

(95% CI, 40-65)

(≥7-point reduction in LSSd summary score) with REZUROCK 200 mg once daily in the mITT population in an exploratory analysis

Both responders (61%) and nonresponders (25%) had improved QOL scores.7

dThe 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.4

eBased on a final analysis by the FDA (n=65).

hThrough cycle 7 day 1.1

52%

OF PATIENTSe REPORTED IMPROVEMENTS IN QOL

(95% CI, 40-65)

CLINICALLY MEANINGFUL IMPROVEMENTS IN PATIENT-REPORTED QOL1,h

(≥7-point reduction in LSSd summary score) with REZUROCK 200 mg once daily in the mITT population in an exploratory analysis

  • Both responders (61%) and nonresponders (25%) had improved QOL scores7

dThe 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.4

eBased on a final analysis by the FDA (n=65).

hThrough cycle 7 day 1.1

REDUCTION IN USE OF CS AND CNI THERAPIES IN THE 200-mg ONCE-DAILY ARM2,3,g

Patients who received CS therapy2,e

Doses were
reduced in

64%

of patients (n=42).

THE MEAN Dose
was reduced by

43%

in patients.

A mean CS dose reduction of 49% and 22% was observed in responders and nonresponders,i respectively.

Treatment was discontinued in

20%

of patients (n=13).

Patients who received CNI therapy3,e

Doses were
reduced in

42%

of patients (n=10).

Treatment was
discontinued in

17%

of patients (n=4).

eBased on a final analysis by the FDA (n=65).

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

iNonresponders were defined as patients with CR or PR in ≥1 organ, accompanied by progression in another organ (considered progression); outcomes that did not meet the criteria for CR, PR, progression or mixed response; or progression in ≥1 organ or site without a response in any other organ or site.5

TOLERABILITY IS KEY.8

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; QOL, quality of life; TTR, time to response.

References: 1. REZUROCK. Package insert. Kadmon Pharmaceuticals, LLC; 2021. 2. 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 3. Data on file 1. Kadmon Pharmaceuticals, LLC; 2021. 4. 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 5. Data on file 2. Kadmon Pharmaceuticals, LLC; 2019. 6. Data on file 3. Kadmon Pharmaceuticals, LLC; 2021. 7. Data on file 4. Kadmon Pharmaceuticals, LLC; 2021. 8. Broadening the definition of tolerability in cancer clinical trials to better measure the patient experience. Friends of Cancer Research. Published October 24, 2018. Accessed April 19, 2022. https://www.focr.org/sites/default/files/Comparative Tolerability Whitepaper_FINAL.pdf

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