ORGOVYX Is the Only Oral Once-a-Day GnRH Receptor Antagonist for Advanced Prostate Cancer1,2
THANKS TO YOU,
TESTOSTERONE CAN
BE CONTROLLED
THROUGHOUT
THE DIVE.
PRIMARY ENDPOINT
SUSTAINED
TESTOSTERONE SUPPRESSION TO <50 ng/dL1
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
(n=308) achieved and maintained testosterone suppression to <50 ng/dL from Day 29 through Week 481

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
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 excluded if they had received previous systemic cytotoxic treatment for prostate cancer, a previous GnRH analog or other form of ADT >18 months total duration, or experienced significant cardiac conditions within 6 months before study entry.1-3

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 [or 11.25 mg* in Japan and Taiwan per local guidelines]) subcutaneously every 3 months (n=308) 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 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 4
    • 0% of men treated with leuprolide had testosterone levels <50 ng/dL on Day 41
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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
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EXPLORATORY ANALYSIS
RECOVERY
OF TESTOSTERONE LEVELS 90 DAYS
AFTER DISCONTINUATION1,2,4
  • 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 discontinuation1,2,4,‡
    • 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
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Kaplan-Meier estimates within each group.1
IN THE HERO STUDY
SAFETY
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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88% of patients§ are covered nationwide
99% of Medicare patients are covered for ORGOVYX
SEE FORMULARY COVERAGE
IN YOUR AREA

§Patients includes Commercial, Medicare, and Medicaid. Formulary data are provided by MMIT, LLC, as of August, 2022.

Sources: Formulary data are provided by MMIT, LLC, as of August, 2022. Transaction data are provided by SHS database as of August, 2022. May not include all plans. Data on File. This data does not include generics. 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.

IMPORTANT SAFETY INFORMATION & INDICATION

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.

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 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: Myovant Sciences, Inc.; 2020.
  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. Shore ND, Saad F, Cookson MS, et al. HERO phase 3 trial: results comparing relugolix, an oral GnRH receptor antagonist, versus leuprolide acetate for advanced prostate cancer. Presented at: American Society of Clinical Oncology Virtual Scientific Program; May 29-June 2, 2020; virtual. Abstract 5602.
  4. Data on file. Myovant Sciences, Inc.