OrgoVyx – pro
U.S. Food and Drug Administration approved Orgovyx (relugolix) for the treatment of adult patients with advanced prostate cancer. Which is better Lupron or Orgovyx?
In a large clinical trial, the drug, relugolix (Orgovyx), was shown to be more effective at reducing testosterone levels in men with advanced prostate cancer than another commonly used treatment, leuprolide (Lupron). However, a clinical advantage to it is not proven.
Orgovyx was approved based on data generated from the HERO trial. HERO was a randomized, open-label, parallel-group study evaluating relugolix against a leuprolide 3-month injection (Lupron) in men with advanced prostate cancer.
HERO demonstrated that Orgovyx was superior to Lupron in maintaining castration from day 29 up to week 48. Orgovyx also showed an almost a five-fold reduction in the risk of subsequent major cardiac events, a concern for men on Lupron.
However, the use of Oroglyx for second-line hormonal therapy had not been published.
Relugolix is increasingly being frequently used in combination with other medications for prostate cancer in patients both new to androgen-deprivation therapy and continuing androgen-deprivation therapy in a real-world study., but without sufficient published evidence, and I support denial. Suchs studies are just beginning to be reproted.
Orgovyx [package insert]. Brisbane, CA: Myovant Sciences, Inc.; December 2022.
NCCN Drugs & Biologics Compendium® Relugolix 2021. National Comprehensive Cancer Network, Inc. Accessed on August 6, 2021.
Shore ND, Saad F, Cookson MS, George DJ, Saltzstein DR, Tutrone R, Akaza H, Bossi A, van Veenhuyzen DF, Selby B, Fan X, Kang V, Walling J, Tombal B; HERO Study Investigators. Oral Relugolix for Androgen-Deprivation Therapy in Advanced Prostate Cancer. N Engl J Med. 2020 Jun 4;382(23):2187-2196.
McKay RR, Gandhi R, Yang E, Pruett J, Nwokeji E, Fallick M. Real-world combination therapy patterns in patients receiving leuprolide or relugolix for androgen deprivation therapy in 2021 (The REAL-ADT COMBO Study): Analysis from a US EMR database. Abstract presented at: 2023 ASCO GU Cancers Symposium; February 16-18, 2023; San Francisco, CA. Accessed February 17, 2023.
De La Cerda, J., Dunshee, C., Gervasi, L. et al. A Phase I Clinical Trial Evaluating the Safety and Dosing of Relugolix with Novel Hormonal Therapy for the Treatment of Advanced Prostate Cancer. Targ Oncol 18, 383–390 (2023).