The Food and Drug Administration has approved a new drug for men with advanced prostate cancer. The approval is for a first in kind hormone therapy (ADT) taken orally (by mouth) instead of the regular Lupron type injections we have been using.
The drug (pill) is called relugolix (trade name – Orgovyx, pronounced Or-Go Vix). For our technical readers, Orgovyx is the first oral gonadotropin-releasing hormone (GnRH) receptor antagonist approved by the FDA for men with advanced prostate cancer.
The efficacy of Orgovyx was demonstrated in the HERO Trial (NCT03085095). HERO was a randomized, open label trial in men with either a prostate cancer recurrence following the failure of radiation or surgery or in men with newly diagnosed castration-sensitive advanced prostate cancer requiring at least one year of androgen deprivation therapy (ADT).
The trial included 934 randomized men (2:1) to receive Orgovyx 360 mg oral loading dose on the first day, followed by daily oral doses of 120 mg, or leuprolide acetate 22.5 mg (Lupron) injection subcutaneously every 3 months for 48 weeks.
The primary endpoint or the main efficacy measure was the ability of Orgovyx to achieve medical castration, defined as achieving and maintaining serum testosterone suppression to castrate levels (< 50 ng/dL) and continuing through 48 weeks of treatment. The actual rate that Orgovyx achieved this measure during the HERO Trial was 96.7% (95% CI: 94.9%, 97.9%), which was superior to the Lupron control, which only achieved an 88.8% castration rate.
The adverse side effects experienced by the men who were given Orgovyx were similar to those we see in men who take Lupron.
The most common adverse reactions (≥ 10%) in men receiving Orgovyx were hot flush (54%), musculoskeletal pain (30%), fatigue (26%), constipation (12%), and diarrhea (12%).
The most common laboratory abnormalities (≥ 15%) in men receiving ORGOVYX were glucose increased (44%), triglycerides increased (35%), hemoglobin decreased (28%), alanine aminotransferase increased (27%), and aspartate aminotransferase increased (18%).
Besides achieving and maintaining adequate levels of castration, Orgovyx was also superior to Lupron because it cut the incidence of serious heart events compared to Lupron.
Cancer ABCs is excited about this approval, especially during the pandemic, because it will allow men to treat their prostate cancer with ADT without increasing their exposure to hospitals and doctors' offices. We are also pleased that Orgovyx seems to be superior to Lupron in achieving and maintaining levels of castration while also having less serious heart issues.
Despite our enthusiasm, we must caution any man who moves from Lupron to Orgovyx that they must be diligent about taking the medication every day. We are not familiar with any data that shows how quickly testosterone might recover if the medication is missed or stopped.
We also want to point out that men who are using a strong CYP3A inducer like Apalutamide (Nubequa), Enzalutamide (Xtandi), and possibly moderate CYP3A inducers like Dexamethasone, estradiol or St. John's Wort need to discuss the dosing and the timing of taking Orgovyx with their doctor and their pharmacist.
An unknown is a cost for Orgovyx and the reimbursement rate.
The recommended relugolix dose is a loading dose of 360 mg on the first day, followed by a daily oral dose of 120 mg at approximately the same time with or without food.
View full prescribing information for ORGOVYX.
