REZUROCK® (belumosudil) Pivotal ROCKstar Study Efficacy Data

For US Health Care
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Information CONNECT WITH A REPRESENTATIVE

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 therapy^1,2

pink circle icon with a white check mark

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

Clinically meaningful ORRs observed across key subgroups²

Responses across all evaluated organs, including those with fibrotic manifestations²

Most responses were seen between 4 and 8 weeks³

FFS^b rate at 6 and 12 months and OS^c rate at 24 months^2,3

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

Reduction in use of CS and CNI therapies^2,3

^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 ORR^a FOLLOWING TREATMENT WITH REZUROCK 200 mg ONCE DAILY^1,5,6

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

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

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)

62^%

OF THE RESPONDER POPULATION^e

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).

FFS^b,g WITH REZUROCK 200 mg ONCE DAILY IN THE mITT POPULATION^2,3

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.

OS^c,gWITH 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 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 QOL^1,h

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

52^%

OF PATIENTS^e REPORTED IMPROVEMENTS IN QOL

(95% CI, 40-65)

(≥7-point reduction in LSS^d 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

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

^hThrough cycle 7 day 1.¹

52^%

OF PATIENTS^e REPORTED IMPROVEMENTS IN QOL

(95% CI, 40-65)

CLINICALLY MEANINGFUL IMPROVEMENTS IN PATIENT-REPORTED QOL^1,h

(≥7-point reduction in LSS^d 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

^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 ARM^2,3,g

Patients who received CS therapy^2,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 therapy^3,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; 2023. 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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THE ROCKstar STUDY

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

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

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

EARLY cGVHD DIAGNOSIS

89%

SEVERE cGVHD

76%

cGVHD INVOLVING ≥4 ORGANS

73%

>3 PRIOR LINES OF SYSTEMIC THERAPY

70%

REFRACTORY TO THEIR PRIOR LINE OF SYSTEMIC THERAPY

75%

PRIOR IBRUTINIB THERAPY

73%

PRIOR RUXOLITINIB THERAPY

PRIOR RUXOLITINIB THERAPY

65%

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

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

62%

OF THE RESPONDER POPULATIONe

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

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

CLINICALLY MEANINGFUL IMPROVEMENTS IN PATIENT-REPORTED QOL1,h

52%

OF PATIENTSe REPORTED IMPROVEMENTS IN QOL

(95% CI, 40-65)

52%

OF PATIENTSe REPORTED IMPROVEMENTS IN QOL

(95% CI, 40-65)

CLINICALLY MEANINGFUL IMPROVEMENTS IN PATIENT-REPORTED QOL1,h

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%

THE MEAN Dose was reduced by

43%

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

Treatment was discontinued in

20%

Patients who received CNI therapy3,e

Doses were reduced in

42%

Treatment was discontinued in

17%

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Please verify that you are a US health care professional

Clinically meaningful responses with REZUROCK were seen across all patient types after failure of ≥2 prior lines of therapy^1,2

STATISTICALLY SIGNIFICANT ORR^a FOLLOWING TREATMENT WITH REZUROCK 200 mg ONCE DAILY^1,5,6

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

89^%

76^%

73^%

70^%

75^%

73^%

65^%

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

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

62^%

OF THE RESPONDER POPULATION^e

FFS^b,g WITH REZUROCK 200 mg ONCE DAILY IN THE mITT POPULATION^2,3

OS^c,gWITH REZUROCK 200 mg ONCE DAILY IN THE mITT POPULATION³

CLINICALLY MEANINGFUL IMPROVEMENTS IN PATIENT-REPORTED QOL^1,h

52^%

OF PATIENTS^e REPORTED IMPROVEMENTS IN QOL

52^%

OF PATIENTS^e REPORTED IMPROVEMENTS IN QOL

CLINICALLY MEANINGFUL IMPROVEMENTS IN PATIENT-REPORTED QOL^1,h

REDUCTION IN USE OF CS AND CNI THERAPIES IN THE 200-mg ONCE-DAILY ARM^2,3,g

Patients who received CS therapy^2,e

Doses were
reduced in

64^%

THE MEAN Dose
was reduced by

43^%

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

20^%

Patients who received CNI therapy^3,e

Doses were
reduced in

42^%

Treatment was
discontinued in

17^%