Background: Relugolix is an oral GnRH receptor antagonist approved for men with advanced prostate cancer. Relugolix treatment has demonstrated an ability to lower testosterone to sustained castration levels in the phase 4 HERO study. Herein, we describe the results of a secondary endpoint of castration resistance-free survival (CRFS) during 48 weeks of treatment and profile patients with castration-resistant prostate cancer (CRPC). Methods: Subjects were 2:1 randomized to either relugolix 120 mg orally once daily (after a single 360 mg loading dose) or 3-monthly injections of leuprolide for 48 weeks. CRFS, defined as the time from the date of first dose to the date of confirmed prostate-specific antigen progression while castrated or death due to any reason was conducted in the metastatic disease population and the overall modified intention-to-treat (mITT) populations. Results: The CRFS analysis (mITT population) included 1074 men (relugolix: n = 717; leuprolide: n = 357) with advanced prostate cancer as well as 434 men (relugolix: n = 290; leuprolide: n = 144) with metastatic prostate cancer. In the metastatic disease populations, CRFS rates were 74.3% (95% CI: 68.6%, 79.2%) and 75.3% (95% CI: 66.7%, 81.9%) in the relugolix and leuprolide groups, respectively (hazard ratio: 1.03 [0.68, 1.57]; p = 0.84) at week 48. Results in the overall mITT population were similar to the metastatic population. No new safety findings were identified. Conclusions: In men with metastatic disease or in the overall population of the HERO study, CRFS assessed during the 48-week treatment with relugolix was not significantly different than standard-of-care leuprolide. Relugolix had similar efficacy for men with/without CRFS progression events.
Cancers. 2023 Oct 05*** epublish ***
Fred Saad, Daniel J George, Michael S Cookson, Daniel R Saltzstein, Ronald Tutrone, Alberto Bossi, Bruce Brown, Bryan Selby, Sophia Lu, Bertrand Tombal, Neal D Shore
University of Montreal Hospital Centre, Montreal, QC H2X 3E4, Canada., Duke Cancer Institute Center for Prostate and Urologic Cancers, Duke University, Durham, NC 27710, USA., Department of Urology, The University of Oklahoma Health Sciences Center, Oklahoma City, OK 73104, USA., Urology San Antonio, San Antonio, TX 78229, USA., Chesapeake Urology, Towson, MD 21204, USA., Department of Radiation Oncology, Gustave Roussy Cancer Institute, 94805 Villejuif, France., Myovant Sciences, Inc., Brisbane, CA 94005, USA., Institut de Recherche Clinique, Université Catholique de Louvain, B-1348 Brussels, Belgium., Carolina Urologic Research Center, Myrtle Beach, SC 29572, USA.