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%).111.25 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.