MP24-07 RELUGOLIX VS LEUPROLIDE EFFECTS ON CASTRATION RESISTANCE-FREE SURVIVAL FROM THE PHASE 3 HERO STUDY IN MEN WITH ADVANCED PROSTATE CANCER

You have accessJournal of UrologyProstate Cancer: Advanced (including Drug Therapy) II (MP24)1 Sep 2021MP24-07 RELUGOLIX VS LEUPROLIDE EFFECTS ON CASTRATION RESISTANCE-FREE SURVIVAL FROM THE PHASE 3 HERO STUDY IN MEN WITH ADVANCED PROSTATE CANCER Fred Saad, Daniel George, Michael Cookson, Saltzstein, Ronald Tutrone, Hideyuki Akaza, Alberto Bossi, Bruce Brown, Bryan Selby, Sophia Lu, Jackie Walling, Bertrand Tombal, and Neal Shore SaadFred Saad More articles by this author , GeorgeDaniel George CooksonMichael Cookson SaltzsteinDaniel Saltzstein TutroneRonald Tutrone AkazaHideyuki Akaza BossiAlberto Bossi BrownBruce Brown SelbyBryan Selby LuSophia Lu WallingJackie Walling TombalBertrand Tombal ShoreNeal View All Author Informationhttps://doi.org/10.1097/JU.0000000000002015.07AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Androgen deprivation therapy is a foundational for achieving castration levels men with advanced prostate cancer (aPC). Relugolix, an FDA-approved, oral GnRH receptor antagonist, demonstrated suppression testosterone castrate in 96.7% men, which was superior leuprolide (88.8%), 54% risk reduction major adverse cardiovascular events relative the phase study (NCT03085095). METHODS: The multinational randomized, open-label, parallel group evaluate safety efficacy relugolix aPC. Men were randomized 2:1 receive 120 mg orally once-daily after single loading dose 360 or 3-monthly injections 48 weeks. To further characterize profile relugolix, additional 101 assess secondary end point resistance-free survival (CRFS) during 48-weeks treatment metastatic cancer, clinically relevant indicator disease progression final analysis. CRFS defined as time from date first confirmed prostate-specific antigen (defined Prostate Cancer Clinical Trials Working Group 3) while castrated death due any reason, whichever occurs earlier. analysis conducted cohort well overall modified intention-to-treat (mITT) population. RESULTS: Overall, 1074 aPC (relugolix: n=717; leuprolide: n=357) 434 n=290; n=144) included (mITT population). Mean age 71 years, 29% over 75 years age. North South America (28.9% 6.4%), Europe (37.8%), Asia/rest world (26.9%). At entry, most common location metastasis bone only (53%). rates at week 74.3% (95% CI: 68.6%, 79.2%) 75.3% 66.7%, 81.9%) groups, respectively (hazard ratio: 1.03 [0.68, 1.57]; p=0.84). Results similar mITT No new findings identified. CONCLUSIONS: In study, assessed 48-week not significantly different than standard-of-care subgroup Source Funding: Myovant Sciences GmBH, collaboration Pfizer © 2021 American Urological Association Education Research, Inc.FiguresReferencesRelatedDetails Volume 206Issue Supplement 3September 2021Page: e414-e414 Advertisement Copyright & Permissions© Inc.MetricsAuthor Information Expand Loading ...