*Two patients in each arm did not receive the study treatment and were not included.
†The dosage of leuprolide was 11.25 mg in Japan and Taiwan, per local guidelines, and is not recommended for this indication in the United States.
PSA=prostate-specific antigen; SC=subcutaneous.
‡This endpoint was analyzed for exploratory purposes without formal testing.
Key inclusion criteria1,2
Key exclusion criteria2,3
ECOG=Eastern Cooperative Oncology Group; GnRH=gonadotropin-releasing hormone.
§When applicable, post radical prostatectomy of >0.2 ng/mL or post radiotherapy, cryotherapy, or high-frequency ultrasound >2.0 ng/mL above the postinterventional nadir.
See Key Enrollment Criteria above for exclusion criteria about cardiovascular risk conditions.
||Biochemical relapse was defined by a rising PSA level.
¶ECOG performance status ranges from 0 to 5, with higher scores reflecting greater disability.
#One patient in the leuprolide group had a surgical vascular procedure on his leg and was given an ECOG score of 3 at screening because of the use of crutches. By the baseline Day 1 visit, the patient no longer used crutches, and his ECOG score had improved to 0.
**Patients with multiple risk factors were counted only once.
††Included current/past tobacco smoking, heavy alcohol use, and a BMI >30 kg/m2.
‡‡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.
§§Search criteria included "myocardial infarction" (broad standardized MedDRA query), "central nervous system hemorrhages and cerebrovascular conditions" (broad standardized MedDRA query).
MedDRA=Medical Dictionary for Regulatory Activities; SD=standard deviation.
aKaplan-Meier estimates within each group.
bThe testosterone suppression rate of the subgroup of patients receiving leuprolide 22.5 mg (n=264) was 88.0% (95% CI: 83.4-91.4).
Adapted with permission from the New England Journal of Medicine.
cKaplan-Meier estimates within each group.
dKaplan-Meier estimates within each group.
PSA results should be interpreted with caution because of the heterogeneity of the patient population studied. No evidence has shown that the rapidity of PSA decline is related to a clinical benefit.1
ORGOVYX testosterone recovery 90 days after discontinuation1,2,4
Adapted with permission from the New England Journal of Medicine.
eThis 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.
fKaplan-Meier estimates within each group.
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.
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%).
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.
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.
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