Who may be right for ORGOVYX?

In the HERO clinical trial, ORGOVYX was studied in a range of patients with advanced prostate cancer, each with their own clinical disease presentation, lifestyle, and history.1 These four hypothetical examples are representative of patients enrolled in the HERO study. Please see study design for more information.

Explore four hypothetical patient profiles based on characteristics of patients studied in HERO.

Fred is a 68-year-old man who was diagnosed with locally advanced prostate cancer 14 months ago and has recently become biochemically recurrent.

Fred is representative of the characteristics of patients studied in the ORGOVYX arm at baseline in the HERO trial:

  • 49.7% of patients had evidence of biochemical or clinical relapse after local primary intervention with curative intent2*
  • 71.4% of patients were ≤75 years of age2
Initial Clinical Evaluation (14 Months Ago)

Stage: T3a, N0, M0

Gleason score: 7 (3+4)

PSA: 8 ng/mL

ECOG PS: 0

mpMRI: Evidence of extraprostatic extension

Treatment History (12 Months Ago)
  • Radical prostatectomy (PSA <0.1 ng/mL post surgery)
  • Negative surgical margins
  • Pelvic lymph node dissection showed no lymph node involvement
  • No history of ADT
Current Clinical Evaluation

PSA: 0.4 ng/mL

PSMA PET: Negative

Lifestyle
  • Works as a consultant for an engineering company and frequently travels on short notice
  • Enjoys going to the movies with his wife, working in their garden, and actively participating in his church activities on the weekends
  • Based on his discussions with other members of his prostate cancer support group, is curious about the long-term impacts of ADT therapy

Hypothetical patient profiles are based on characteristics of patients studied at baseline in the HERO trial. This is neither intended to be medical advice nor a substitute for professional medical judgment.

*Biochemical relapse was defined by a rising PSA level.2

ADT=androgen deprivation therapy; ECOG PS=Eastern Cooperative Oncology Group performance status; M=metastasis; mpMRI=multiparametric magnetic resonance imaging; N=node; PSMA PET=prostate-specific membrane antigen positron emission tomography; PSA=prostate-specific antigen; T=tumor.

James is a 64-year-old man with locally advanced prostate cancer.

James is representative of the characteristics of patients studied in the ORGOVYX arm at baseline in the HERO trial:

  • 27.7% of patients had advanced localized disease not suitable for primary surgical intervention with curative intent2
  • 71.4% of patients were ≤75 years of age2
  • 78.5% of patients had cardiovascular or cerebrovascular risk factors2†
  • 13.5% of patients had a history of major cardiovascular events2‡
Initial Clinical Evaluation (4 weeks ago)

Stage: cT3b, N0, M0

Gleason score: 8 (4+4)

PSA: 11.3 ng/mL

ECOG PS: 0

Bone scan: Negative

PSMA PET: Shows seminal vesicle invasion.

Referred for treatment consideration after preventive screening results indicated elevated PSA.

Treatment History
  • None
Comorbidities
  • Myocardial infarction 1 year ago
  • Hypertension
  • Hyperlipidemia
Lifestyle
  • Works as a software analyst
  • Lives on a farm where he also breeds horses
  • Spends his free time hiking with his dogs, caring for his horses, and visiting the city on weekends
  • Takes many oral medications in the morning at breakfast (aspirin 81 mg daily, clopidogrel 75 mg daily, atorvastatin 80 mg daily, metoprolol succinate 100 mg daily, ezetimibe 10 mg daily)

Hypothetical patient profiles are based on characteristics of patients studied at baseline in the HERO trial. This is neither intended to be medical advice nor a substitute for professional medical judgment.

†Cardiovascular or cerebrovascular risk factors included hypertension; dyslipidemia; diabetes; a history of myocardial infarction or cardiovascular disease; a history of stroke, transient ischemic attack, or cerebral hemorrhage; peripheral arterial disease; atrial fibrillation and other arrhythmias; heart valve disease; chronic obstructive pulmonary disease; chronic kidney disease; chronic liver disease; carotid artery stenosis or occlusion; venous thromboembolic events; and heart failure.2
‡Search criteria included “myocardial infarction” (broad standardized MedDRA query) and “central nervous system hemorrhages and cerebrovascular conditions” (broad standardized MedDRA query).2

cT=clinical tumor; ECOG PS=Eastern Cooperative Oncology Group performance status; M=metastasis; MedDRA=Medical Dictionary for Regulatory Activities; N=node; PSA=prostate-specific antigen; PSMA PET=prostate-specific membrane antigen positron emission tomography.

David is a 77-year-old man recently diagnosed with de novo metastatic prostate cancer.

David is representative of the characteristics of patients studied in the ORGOVYX arm at baseline in the HERO trial:

  • 22.7% of patients had newly diagnosed androgen-sensitive metastatic disease2
  • 67.8% of patients had lifestyle risk factors for cardiovascular disease2§
  • 78.5% of patients had cardiovascular or cerebrovascular risk factors2||
Initial Clinical Evaluation (2 Weeks Ago)

Stage: T3, N1, M1

Gleason score: 9 (4+5)

PSA: 298 ng/mL

ECOG PS: 1

PSMA PET: Enlarged pelvic lymph nodes, multiple bone metastases (lesions in 5 sites)

Treatment History
  • None
Comorbidities
  • High symptom burden: lower back pain with occasional numbness in left toes, urinary retention
  • Osteoporosis
  • Obesity (body mass index: 42.0 kg/m²)
  • Hypertension
  • Hyperlipidemia
Lifestyle
  • Retired security guard with a lower income
  • Lives in a rural setting 3 hours from the nearest care center
  • Lives with son and daughter-in-law
  • Prefers oral medications

Hypothetical patient profiles are based on characteristics of patients studied at baseline in the HERO trial. This is neither intended to be medical advice nor a substitute for professional medical judgment.

§Lifestyle risk factors included current/past tobacco smoker, heavy alcohol use, and body mass index of >30 kg/m2.2
||Cardiovascular or cerebrovascular risk factors included hypertension; dyslipidemia; diabetes; a history of myocardial infarction or cardiovascular disease; a history of stroke, transient ischemic attack, or cerebral hemorrhage; peripheral arterial disease; atrial fibrillation and other arrhythmias; heart valve disease; chronic obstructive pulmonary disease; chronic kidney disease; chronic liver disease; carotid artery stenosis or occlusion; venous thromboembolic events; and heart failure.2

ECOG PS=Eastern Cooperative Oncology Group performance status; M=metastasis; N=node; PSA=prostate-specific antigen; PSMA PET=prostate-specific membrane antigen positron emission tomography; T=tumor.

Stan is a 78-year-old man with recurrent metastatic prostate cancer that was first diagnosed 8 years ago as locally advanced disease.

Stan is representative of the characteristics of patients studied in the ORGOVYX arm at baseline in the HERO trial:

  • 49.7% of patients had evidence of biochemical or clinical relapse after local primary intervention with curative intent2¶
  • 78.5% of patients had cardiovascular or cerebrovascular risk factors2#
  • 13.5% of patients had a history of major cardiovascular events2**
Initial Clinical Evaluation (14 months ago)

Stage: T3a, N1, M0

Gleason score: 8 (4+4)

PSA: 5 ng/mL

ECOG PS: 0

Treatment History

8 years ago

  • Initial treatment with radical prostatectomy and adjuvant EBRT
  • PSA <0.1 ng/mL post surgery

5 years ago

  • Biochemical recurrence (PSA 0.3 ng/mL)
  • Treated with salvage ADT for 16 months
Current Clinical Evaluation

PSA: 1.5 ng/mL

PSA DT: 4 months

PSMA PET: 2 pelvic lymph node lesions and development of vertebral bone metastasis

Comorbidities
  • Myocardial infarction 3 years ago
  • Bone pain, back/lumbar pain, type 2 diabetes, hypertension, hyperlipidemia
Lifestyle
  • Retired from corporate law
  • Enjoys spending time with his partner
  • Remains mobile despite experiencing back and bone pain, which raised concerns that his cancer may have recurred
  • Takes oral medications, including aspirin 81 mg daily, rosuvastatin 20 mg daily, metoprolol succinate 100 mg daily and losartan 100 mg daily

Hypothetical patient profiles are based on characteristics of patients studied at baseline in the HERO trial. This is neither intended to be medical advice nor a substitute for professional medical judgment.

Biochemical relapse was defined by a rising PSA level.2
#Cardiovascular or cerebrovascular risk factors included hypertension; dyslipidemia; diabetes; a history of myocardial infarction or cardiovascular disease; a history of stroke, transient ischemic attack, or cerebral hemorrhage; peripheral arterial disease; atrial fibrillation and other arrhythmias; heart valve disease; chronic obstructive pulmonary disease; chronic kidney disease; chronic liver disease; carotid artery stenosis or occlusion; venous thromboembolic events; and heart failure.2
**Search criteria included “myocardial infarction” (broad standardized MedDRA query) and “central nervous system hemorrhages and cerebrovascular conditions” (broad standardized MedDRA query).2

ADT=androgen deprivation therapy; EBRT=external beam radiation therapy; ECOG PS=Eastern Cooperative Oncology Group performance status; M=metastasis; MedDRA=Medical Dictionary for Regulatory Activities; N=node; PSA=prostate-specific antigen; PSA DT=PSA doubling time; PSMA PET=prostate-specific membrane antigen positron emission tomography; T=tumor.

Hypothetical patient profiles are based on characteristics of patients studied at baseline in the HERO trial. This is neither intended to be medical advice nor a substitute for professional medical judgment.

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IMPORTANT SAFETY INFORMATION

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 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 an oral P-gp inhibitor increases relugolix exposure, 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 and separate dosing by at least 6 hours. Monitor patients for increased adverse reactions. Treatment with ORGOVYX may be interrupted for up to 2 weeks if a short course of treatment with a P-gp inhibitor is required. Resume ORGOVYX after the P-gp inhibitor is discontinued. If treatment with ORGOVYX is interrupted for greater than 7 days, restart ORGOVYX with a 360 mg loading dose on the first day and continue with 120 mg once daily.

Co-administration of ORGOVYX with a combined P-gp and strong CYP3A inducer decreases relugolix exposure, 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.

Please see full Prescribing Information for ORGOVYX.

INDICATION

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

References: 1. ORGOVYX (relugolix). Prescribing information. Sumitomo Pharma America, Inc.; 2025. 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. doi:10.1056/NEJMoa2004325