THE ROCKstar STUDY

man wearing headphones while playing the guitar
man wearing headphones while playing the guitar

REZUROCK was evaluated in the pivotal ROCKstar (KD025-213) study in a real-world demographic of patients with cGVHD1

The FDA approval of REZUROCK was based on the pivotal ROCKstar study.1

The ROCKstar study included a broad range of patients who were representative of the general cGVHD population.1

These patients had

  • Early-stage cGVHD as well as late-stage disease1
  • Diverse ages (≥12 years)1
  • NIH-defined moderate (27%) or severe (70%) cGVHD2
  • A wide range of organ involvement, including fibrotic manifestations1,2
  • A diverse treatment history2
  • Median of 3 prior lines of systemic therapy (30% had received ruxolitinib and 33% had received ibrutinib)

Study design for ROCKstar2

ROCKstar study criteria with REZUROCK treatment arms and end points, including overall response rate (ORR), safety, duration of response (DOR), Lee Symptom Scale (LSS) score, steroid doses, failure-free survival (FFS) and overall survival (OS) ROCKstar study criteria with REZUROCK treatment arms and end points, including overall response rate (ORR), safety, duration of response (DOR), Lee Symptom Scale (LSS) score, steroid doses, failure-free survival (FFS) and overall survival (OS)

Study design1,2

ROCKstar was a pivotal phase 2, open-label, randomized, multicenter study that evaluated the efficacy and safety of REZUROCK in patients with cGVHD.

aThe 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.

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

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

Select baseline characteristics2

The baseline demographics demonstrate the diversity of the patient population in the ROCKstar study. Many patients presented with challenging characteristics, including advanced or complex disease and having received multiple prior lines of systemic therapy.

baseline characteristics of patients, including median prior lines of systemic therapy, organ involvement, previous acute GVHD (aGVHD) and other characteristics
baseline characteristics of patients, including median prior lines of systemic therapy, organ involvement, previous acute GVHD (aGVHD) and other characteristics

aThe 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.

Most patients in the ROCKstar study had moderate or severe cGVHD based on the 2014 NIH cGVHD Consensus Criteria2

horizontal bar graph of REZUROCK 200-mg once-daily treatment arm, REZUROCK 200-mg twice-a-day (BID) treatment arm and total study participants
horizontal bar graph of REZUROCK 200-mg once-daily treatment arm, REZUROCK 200-mg twice-a-day (BID) treatment arm and total study participants

aThe 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.

chart of organ involvement, including the eyes, skin, mouth, joints/fascia, lungs, upper GI tract, esophagus, lower GI tract and liver
chart of organ involvement, including the eyes, skin, mouth, joints/fascia, lungs, upper GI tract, esophagus, lower GI tract and liver

aThe 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.

Efficacy was achieved

across a diverse range of patients.1

See the results

aGVHD, acute graft-versus-host disease; BID, twice a day; cGVHD, chronic graft-versus-host disease; CNI, calcineurin inhibitor; CS, corticosteroids; DOR, duration of response; ECP, extracorporeal photopheresis; FFS, failure-free survival; GI, gastrointestinal; HCT, hematopoietic cell transplant; LSS, Lee Symptom Scale; MOA, mechanism of action; NIH, National Institutes of Health; ORR, overall response rate; OS, overall survival; PPI, proton pump inhibitor; QOL, quality of life; TTR, time to 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. Kadmon Pharmaceuticals, LLC; 2021.

Indication

REZUROCKTM (belumosudil) is indicated for the treatment of adult and pediatric patients 12 years and older with chronic graft-versus-host disease (chronic GVHD) after failure of at least two prior lines of systemic therapy.

IMPORTANT SAFETY INFORMATION

Warnings and Precautions

Embryo-Fetal Toxicity: Based on findings in animals and its mechanism of action, REZUROCK can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential and males with female partners of reproductive potential to use effective contraception during treatment with REZUROCK and for at least one week after the last dose

Adverse Reactions

The most common (≥ 20%) adverse reactions, including laboratory abnormalities, were infections, asthenia, nausea, diarrhea, dyspnea, cough, edema, hemorrhage, abdominal pain, musculoskeletal pain, headache, phosphate decreased, gamma glutamyl transferase increased, lymphocytes decreased, and hypertension

Permanent discontinuation of REZUROCK due to adverse reactions occurred in 18% of patients. The adverse reactions which resulted in permanent discontinuation of REZUROCK in > 3% of patients included nausea (4%). Adverse reactions leading to dose interruption occurred in 29% of patients. The adverse reactions leading to dose interruption in ≥ 2% were infections (11%), diarrhea (4%), and asthenia, dyspnea, hemorrhage, hypotension, liver function test abnormal, nausea, pyrexia, edema, and renal failure with (2% each)

Monitor total bilirubin, aspartate aminotransferase (AST), and alanine aminotransferase (ALT) at least monthly

Drug Interactions

Strong CYP3A Inducers: Coadministration of REZUROCK with strong CYP3A inducers decreases belumosudil exposure, which may reduce the efficacy of REZUROCK. Increase the dosage of REZUROCK to 200 mg twice daily when coadministered with strong CYP3A inducers

Proton Pump Inhibitors: Coadministration of REZUROCK with proton pump inhibitors decreases belumosudil exposure, which may reduce the efficacy of REZUROCK. Increase the dosage of REZUROCK to 200 mg twice daily when coadministered with proton pump inhibitors

Use in Specific Populations

Pregnancy: Based on findings from animal studies and the mechanism of action, REZUROCK can cause fetal harm when administered to pregnant women. There are no available human data on REZUROCK use in pregnant women to evaluate for a drug-associated risk. Advise pregnant women and females of reproductive potential of the potential risk to the fetus

Lactation: There are no data available on the presence of belumosudil or its metabolites in human milk or the effects on the breastfed child, or milk production. Because of the potential for serious adverse reactions from belumosudil in the breastfed child, advise lactating women not to breastfeed during treatment with REZUROCK and for at least one week after the last dose

Pediatric Use: The safety and effectiveness of REZUROCK have been established in pediatric patients 12 years and older. The safety and effectiveness of REZUROCK in pediatric patients less than 12 years old have not been established

Geriatric Use: Of the 186 patients with chronic GVHD in clinical studies of REZUROCK, 26% were 65 years and older. No clinically meaningful differences in safety or effectiveness of REZUROCK were observed in comparison to younger patients

Renal and Hepatic Impairment: Treatment with REZUROCK has not been studied in patients with pre-existing severe renal or hepatic impairment. For patients with pre-existing severe renal or hepatic impairment, consider the risks and potential benefits before initiating treatment with REZUROCK

Please see full Prescribing Information for additional Important Safety Information.

You are encouraged to report side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call 1-800-FDA-1088. You may also contact Kadmon Pharmaceuticals, LLC, at 1-877-377-7862 to report side effects.

Indication

REZUROCKTM (belumosudil) is indicated for the treatment of adult and pediatric patients 12 years and older with chronic graft-versus-host disease (chronic GVHD) after failure of at least two prior lines of systemic therapy.

Important safety information Warnings and Precautions

Embryo-Fetal Toxicity: Based on findings in animals and its mechanism of action, REZUROCK can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential and males with female partners of reproductive potential to use effective contraception during treatment with REZUROCK and for at least one week after the last dose

Indication & Important safety information

REZUROCKTM (belumosudil) is indicated for the treatment of adult and pediatric patients 12 years and older with chronic graft-versus-host disease (chronic GVHD) after failure of at least two prior lines of systemic therapy.