LBA02-07 HERO PHASE 3 TRIAL: RESULTS COMPARING RELUGOLIX, AN ORAL GNRH RECEPTOR ANTAGONIST, VS LEUPROLIDE ACETATE FOR ADVANCED PROSTATE CANCER

You have accessJournal of UrologyLate-Breaking Abstracts (LBA2)1 Apr 2020LBA02-07 HERO PHASE 3 TRIAL: RESULTS COMPARING RELUGOLIX, AN ORAL GNRH RECEPTOR ANTAGONIST, VS LEUPROLIDE ACETATE FOR ADVANCED PROSTATE CANCER Neal Shore*, Fred Saad, Michael Cookson, David J. George, Daniel R. Saltzstein, Ronald Tutrone, Hideyuki Akaza, Alberto Bossi, David van Veenhuyzen, Bryan Selby, Xiaolin Fan, Vicky Kang, Jackie Walling, and Bertrand Tombal Neal Shore*Neal Shore* More articles by this author , Fred SaadFred Saad More articles by this author , Michael CooksonMichael Cookson More articles by this author , David J. GeorgeDavid J. George More articles by this author , Daniel R. SaltzsteinDaniel R. Saltzstein More articles by this author , Ronald TutroneRonald Tutrone More articles by this author , Hideyuki AkazaHideyuki Akaza More articles by this author , Alberto BossiAlberto Bossi More articles by this author , David van VeenhuyzenDavid van Veenhuyzen More articles by this author , Bryan SelbyBryan Selby More articles by this author , Xiaolin FanXiaolin Fan More articles by this author , Vicky KangVicky Kang More articles by this author , Jackie WallingJackie Walling More articles by this author , and Bertrand TombalBertrand Tombal More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000000958.07AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract Introduction: LHRH agonists are the mainstay for medical castration in advanced prostate cancer, however, they cause an initial testosterone (T) surge with a delayed onset of castration and require depot injection. Relugolix is the first oral GnRH receptor antagonist, which was previously shown to rapidly suppress T levels. The HERO trial compared the safety and efficacy of relugolix with leuprolide acetate in advanced prostate cancer patients. Methods: HERO is a 48-week, global, pivotal phase 3 trial that randomized 934 patients with androgen-sensitive advanced prostate cancer in a 2:1 ratio to receive relugolix 120 mg orally QD after a single loading dose of 360 mg or leuprolide acetate 3-month depot injection. The primary endpoint was to achieve and maintain serum T suppression to castrate levels (< 50 ng/dL) through 48 weeks. Key secondary endpoints included castration rates at Day 4, profound castration (< 20 ng/dL) rates at Days 4 and 15, PSA response rate at Day 15 and FSH levels at Week 25. Testosterone recovery was evaluated in a subset of 184 patients. Results: A total of 96.7% (95% CI: 94.9%, 97.9%) of men on relugolix achieved and maintained castration through 48 weeks compared to 88.8% on leuprolide. The difference of 7.9% (95% CI: 4.1%, 11.8%) demonstrated non-inferiority (margin -10%) and superiority (P < 0.0001) of relugolix to leuprolide. All key secondary efficacy endpoints tested demonstrated superiority over leuprolide (P < 0.0001). In the testosterone recovery subset, median T levels were 270.76 ng/dL in the relugolix compared to 12.26 ng/dL in the leuprolide group 90 days after discontinuation of therapy. In a prespecified analysis, the incidence of major adverse cardiovascular events (MACE) was lower in the relugolix group than in the leuprolide group (2.9% vs. 6.2%, respectively); otherwise the safety and tolerability profiles were generally similar. Conclusions: Relugolix achieved castration as early as Day 4 and demonstrated superiority over leuprolide in sustained T suppression through 48 weeks, faster T recovery after discontinuation and a 50% reduction in MACE. Relugolix has the potential to become a new standard for T suppression for patients with advanced prostate cancer. Source Of Funding: Myovant Sciences Inc. © 2020 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 203Issue Supplement 4April 2020Page: e1117-e1117 Advertisement Copyright & Permissions© 2020 by American Urological Association Education and Research, Inc.MetricsAuthor Information Neal Shore* More articles by this author Fred Saad More articles by this author Michael Cookson More articles by this author David J. George More articles by this author Daniel R. Saltzstein More articles by this author Ronald Tutrone More articles by this author Hideyuki Akaza More articles by this author Alberto Bossi More articles by this author David van Veenhuyzen More articles by this author Bryan Selby More articles by this author Xiaolin Fan More articles by this author Vicky Kang More articles by this author Jackie Walling More articles by this author Bertrand Tombal More articles by this author Expand All Advertisement PDF downloadLoading ...