ORGOVYX Is the Only Oral Once-a-Day GnRH Receptor Antagonist for Advanced Prostate Cancer1,2

DIVE INTO ORGOVYX

PROVEN
EFFICACY1
ESTABLISHED
SAFETY1
NATIONWIDE
COVERAGE
Testosterone
can be
controlled
Throughout
the dive
PRIMARY ENDPOINT

SUSTAINED
TESTOSTERONE SUPPRESSION TO <50 ng/dL.1

96.7%

(95% CI: 94.9-97.9) of men achieved and maintained testosterone suppression to <50 ng/dL from Day 29 through Week 48 with ORGOVYX (n=622)1

88.8% (95% CI: 84.6-91.8)* of men treated with leuprolide achieved and maintained testosterone suppression to <50 ng/dL from Day 29 through Week 481

See the efficacy data
HERO STUDY DESIGN

THE HERO STUDY was a multinational, randomized, open-label, phase 3 trial in 930 men with advanced prostate cancer. Key inclusion criteria included men with advanced prostate cancer defined as biochemical prostate-specific antigen (PSA) or clinical relapse following local primary intervention with curative intent, newly diagnosed castration-sensitive metastatic disease, or advanced localized disease unlikely to be cured by local primary intervention, requiring at least 1 year of androgen deprivation therapy (ADT), ECOG 0/1. Patients were randomized 2:1 to receive ORGOVYX (360 mg on the first day followed by daily doses of 120 mg orally [n=622]) or leuprolide acetate (22.5 mg injection) for 48 weeks.1,2

*The castration rate of the subgroup of patients receiving 22.5 mg leuprolide (n=264) was 88.0% (95% CI: 83.4%-91.4%).1 11.25 mg in Japan and Taiwan per local guidelines subcutaneously every 3 months [n=308]. 11.25 mg is a dosage regimen that is not recommended for advanced prostate cancer (APC) in the United States.1

Please see additional information about ORGOVYX throughout this website.

SECONDARY ENDPOINT

RAPID
TESTOSTERONE SUPPRESSION1

56%

of men treated with ORGOVYX achieved testosterone suppression to <50 ng/dL on Day 41‡

0% of men treated with leuprolide had testosterone levels <50 ng/dL on Day 41

Learn about this endpoint
SECONDARY ENDPOINT

PROFOUND
TESTOSTERONE SUPPRESSION
DEFINED AS TESTOSTERONE CONCENTRATIONS <20 ng/dL1

78%

of men treated with ORGOVYX achieved profound testosterone suppression to <20 ng/dL on Day 15

1% of men treated with leuprolide had testosterone levels <20 ng/dL on Day 15

Review suppression levels
EXPLORATORY ANALYSIS

RECOVERY
OF TESTOSTERONE LEVELS 90 DAYS
AFTER DISCONTINUATION1-3

  • In a substudy of 184 men who completed 48 weeks of treatment, 55% of 137 men treated with ORGOVYX and 3% of 47 men treated with leuprolide had their testosterone return to above the lower limit of normal range (>280 ng/dL) or baseline values 90 days after treatment discontinuation1-3‡
    • This endpoint was analyzed for exploratory purposes without formal testing. The data from the leuprolide arm were not included in the US Prescribing Information for ORGOVYX
See the exploratory analysis
Kaplan-Meier estimates within each group. 1,3
Safety profile icon
SAFETY PROFILE
OF ORGOVYX WAS ALSO EVALUATED1

The most common adverse events during treatment
with ORGOVYX (≥10%) in the study were hot flush,
musculoskeletal pain, fatigue, constipation, and diarrhea

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ORGOVYX NATIONAL COVERAGE
99%of Medicare patients are covered for ORGOVYX*
94% of commercial patients are covered for ORGOVYX*
SEE FORMULARY COVERAGE
IN YOUR AREA

*This coverage information is provided for informational purposes only; individual plans vary, and this may not include all plans. Sumitomo Pharma America and Pfizer make no representation or guarantee concerning coverage or reimbursement for ORGOVYX; please check with individual payers for plan-specific coverage and reimbursement information and requirements. Nothing herein may be construed as an endorsement, approval, recommendation, representation, or warranty of any kind by any plan or insurer referenced. This information is subject to change without notice. Data on file. Formulary data are provided by MMIT, LLC, as of February, 2023. Transaction data are provided by SHS database as of January, 2023.

IMPORTANT SAFETY INFORMATION & INDICATION
Contraindication

ORGOVYX is contraindicated in patients with severe hypersensitivity to relugolix or to any of the product components.

Warnings and Precautions

QT/QTc Interval Prolongation: Androgen deprivation therapy, such as ORGOVYX may prolong the QT/QTc interval. Providers should consider whether the benefits of androgen deprivation therapy outweigh the potential risks in patients with congenital long QT syndrome, congestive heart failure, or frequent electrolyte abnormalities and in patients taking drugs known to prolong the QT interval. Electrolyte abnormalities should be corrected. Consider periodic monitoring of electrocardiograms and electrolytes.

Hypersensitivity: Angioedema was reported in 0.2% of patients treated with ORGOVYX in HERO. Hypersensitivity reactions, including pharyngeal edema and other serious cases of angioedema, have been reported in post-marketing with ORGOVYX. Advise patients who experience any symptoms of hypersensitivity to temporarily discontinue ORGOVYX and promptly seek medical care. Discontinue ORGOVYX for severe hypersensitivity reactions and manage as clinically indicated.

Embryo-Fetal Toxicity: The safety and efficacy of ORGOVYX have not been established in females. Based on findings in animals and mechanism of action, ORGOVYX can cause fetal harm and loss of pregnancy when administered to a pregnant female. Advise males with female partners of reproductive potential to use effective contraception during treatment and for 2 weeks after the last dose of ORGOVYX.

Laboratory Testing: Therapy with ORGOVYX results in suppression of the pituitary gonadal system. Results of diagnostic tests of the pituitary gonadotropic and gonadal functions conducted during and after ORGOVYX may be affected. The therapeutic effect of ORGOVYX should be monitored by measuring serum concentrations of prostate-specific antigen (PSA) periodically. If PSA increases, serum concentrations of testosterone should be measured.

Adverse Reactions

Serious adverse reactions occurred in 12% of patients receiving ORGOVYX. Serious adverse reactions in ≥0.5% of patients included myocardial infarction (0.8%), acute kidney injury (0.6%), arrhythmia (0.6%), hemorrhage (0.6%), and urinary tract infection (0.5%). Fatal adverse reactions occurred in 0.8% of patients receiving ORGOVYX including metastatic lung cancer (0.3%), myocardial infarction (0.3%), and acute kidney injury (0.2%). Fatal and non-fatal myocardial infarction and stroke were reported in 2.7% of patients receiving ORGOVYX.

Most common adverse reactions (≥10%) and laboratory abnormalities (≥15%) in patients receiving ORGOVYX were hot flush (54%), glucose increased (44%), triglycerides increased (35%), musculoskeletal pain (30%), hemoglobin decreased (28%), alanine aminotransferase increased (27%), fatigue (26%), aspartate aminotransferase increased (18%), constipation (12%), and diarrhea (12%).

Drug Interactions

Co-administration of ORGOVYX with a P-gp inhibitor increases the area under the curve (AUC) and maximum concentration (Cmax) of ORGOVYX, which may increase the risk of adverse reactions associated with ORGOVYX. Avoid co-administration of ORGOVYX with oral P-gp inhibitors. If co-administration is unavoidable, take ORGOVYX first, separate dosing by at least 6 hours, and monitor patients more frequently for adverse reactions. Treatment with ORGOVYX may be interrupted for up to 2 weeks for a short course of treatment with certain P-gp inhibitors. If treatment with ORGOVYX is interrupted for more than 7 days, resume administration of ORGOVYX with a 360 mg loading dose on the first day, followed by 120 mg once daily.

Co-administration of ORGOVYX with a combined P-gp and strong CYP3A inducer decreases the AUC and Cmax of ORGOVYX, which may reduce the effects of ORGOVYX. Avoid co-administration of ORGOVYX with combined P-gp and strong CYP3A inducers. If co-administration is unavoidable, increase the ORGOVYX dose to 240 mg once daily. After discontinuation of the combined P-gp and strong CYP3A inducer, resume the recommended ORGOVYX dose of 120 mg once daily.

INDICATION

ORGOVYX® (relugolix) is a gonadotropin-releasing hormone (GnRH) receptor antagonist indicated for the treatment of adult patients with advanced prostate cancer.

Please see full Prescribing Information for ORGOVYX.

References:
  1. ORGOVYX (relugolix) [prescribing information]. Brisbane, CA: Sumitomo Pharma America, Inc.; 2023.
  2. Shore ND, Saad F, Cookson MS, et al. Oral relugolix for androgen-deprivation therapy in advanced prostate cancer. N Engl J Med. 2020;382(23):2187-2196 and supplementary material, available online.
  3. Data on file. Sumitomo Pharma America, Inc.