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Examine the key secondary end points of the pivotal ROCKstar study


Clinically significant FFS and OS rates, CS and CNI dose reductions



Having trouble viewing this email? View in your browser.   Below is Important
Information From One of Our Sponsors. For patients with cGVHD aged ≥12 years
after failure of at least 2 prior lines of systemic therapy1 For patients with
cGVHD aged ≥12 years after failure of at least 2 prior lines of systemic
therapy1

Belumosudil (REZUROCK™) has been added to the NCCN Clinical Practice Guidelines
in Oncology (NCCN Guidelines®) as a category 2A systemic option for
steroid-refractory cGVHD.4,c

 

REZUROCK achieved clinically significant FFS rates in patients with cGVHD2  
Clinically meaningful OS rates were observed with REZUROCK
in patients with cGVHD2          

REZUROCK achieved clinically
significant FFS rates in
patients with cGVHD2     Clinically meaningful OS rates
were observed with REZUROCK
in patients with cGVHD2    

REZUROCK reduced dependence on CS and CNI therapies for both responders and
nonresponders.3,b  

 

CS dose reductions and discontinuations3   •  CS doses were reduced in 64% of
patients (n=42) in the 200-mg once-daily arm   •  The mean percentage change in
CS dose reduction was 43% in the mITT population who received REZUROCK 200 mg
once daily     –  The mean percentage change in CS dose reduction was 49% in the
responder population who received REZUROCK 200 mg once daily   •  CS therapy was
discontinued in 20% of patients (n=13) in the 200-mg once-daily arm

     

CNI dose reductions and discontinuations2   •  CNI doses were reduced in 42% of
patients (n=10) in the 200-mg once-daily arm   •  CNI therapy was discontinued
in 17% of patients (n=4) in the 200-mg once-daily arm

   

  Kadmon is committed to helping and supporting patients, and their caregivers,
throughout their treatment journey. Learn about the Kadmon ASSIST patient
support services.  

  BID, twice a day; cGVHD, chronic graft-versus-host disease; CNI, calcineurin
inhibitor; CR, complete response; CS, corticosteroid; DOR, duration of response;
FFS, failure-free survival; LSS, Lee Symptom Scale; mITT, modified
intent-to-treat; NCCN, National Comprehensive Cancer Network®; NIH, National
Institutes of Health; OS, overall survival; PR, partial response; TTR, time to
response.  

a Study design: ROCKstar was a pivotal phase 2, open-label, randomized,
multicenter study that evaluated the efficacy and safety of REZUROCK in patients
with cGVHD after receiving 2 to 5 prior lines of systemic therapy. Treatment
consisted of REZUROCK 200 mg once daily (n=66) or REZUROCK 200 mg BID (n=66),
stratified according to cGVHD severity and prior ibrutinib treatment. REZUROCK
was administered continuously until clinically significant progression of cGVHD
or unacceptable toxicity. Primary end point: ORR (proportion of patients who
achieved CR or PR), according to the 2014 NIH cGVHD Consensus Criteria. Key
secondary end points: safety, DOR, TTR, LSS score, change in CS/CNI dose, FFS
and OS.3 b Prespecified secondary end point; not powered to show statistical
significance. c NCCN makes no warranties of any kind whatsoever regarding their
content, use or application and disclaims any responsibility for their
application or use in any way. d FFS was defined as the absence of relapse,
nonrelapse mortality or a need for additional systemic therapy.3 e OS was
defined as the time from the first dose of REZUROCK to the date of death due to
any cause.2

 

References: 1. REZUROCK. Package insert. Kadmon Pharmaceuticals, LLC; 2021. 2.
Data on file. Kadmon Pharmaceuticals, LLC; 2021. 3. 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 4. Referenced with permission from the NCCN
Clinical Practice Guidelines in Oncology (NCCN Guidelines® ) for Hematopoietic
Cell Transplantation (HCT): Pre-Transplant Recipient Evaluation and Management
of Graft-Versus-Host Disease. V.4.2021. © National Comprehensive Cancer Network,
Inc. 2021. All rights reserved. Accessed September 17, 2021. To view the most
recent and complete version of the guideline, go online to NCCN.org

 

INDICATION

REZUROCK™ (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.

 

 

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New York, New York 10016
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450 East 29th Street
New York, New York 10016
All Rights Reserved.
KAD25000261     10/21    

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