MP29-02 EFFICACY AND SAFETY OF DAROLUTAMIDE IN COMBINATION WITH ANDROGEN-DEPRIVATION THERAPY AND DOCETAXEL IN THE NORTH AMERICAN POPULATION FROM ARASENS

Abstract

You have accessJournal of UrologyCME1 Apr 2023MP29-02 EFFICACY AND SAFETY OF DAROLUTAMIDE IN COMBINATION WITH ANDROGEN-DEPRIVATION THERAPY AND DOCETAXEL IN THE NORTH AMERICAN POPULATION FROM ARASENS Neal D. Shore, Bertrand Tombal, Maha Hussain, Fred Saad, Karim Fizazi, Cora N. Sternberg, E. David Crawford, Luke Nordquist, Ronald Tutrone, Laurence Belkoff, Shivani Kapur, Jay Jhaveri, Shankar Srinivasan, Heikki Joensuu, and Matthew R. Smith Neal D. ShoreNeal D. Shore More articles by this author , Bertrand TombalBertrand Tombal More articles by this author , Maha HussainMaha Hussain More articles by this author , Fred SaadFred Saad More articles by this author , Karim FizaziKarim Fizazi More articles by this author , Cora N. SternbergCora N. Sternberg More articles by this author , E. David CrawfordE. David Crawford More articles by this author , Luke NordquistLuke Nordquist More articles by this author , Ronald TutroneRonald Tutrone More articles by this author , Laurence BelkoffLaurence Belkoff More articles by this author , Shivani KapurShivani Kapur More articles by this author , Jay JhaveriJay Jhaveri More articles by this author , Shankar SrinivasanShankar Srinivasan More articles by this author , Heikki JoensuuHeikki Joensuu More articles by this author , and Matthew R. SmithMatthew R. Smith More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003257.02AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: In ARASENS (NCT02799602), darolutamide (DARO) + androgen-deprivation therapy (ADT) + docetaxel significantly reduced the risk of death by 32.5% (HR 0.68, 95% CI 0.57–0.80; P<0.0001) vs placebo (PBO) + ADT + docetaxel in patients (pts) with metastatic hormone-sensitive prostate cancer (mHSPC). DARO maintained quality of life, with similar control of disease-related physical symptoms and pain vs placebo, and had a favorable safety profile. We report clinical outcomes in North American (NA) pts in ARASENS. METHODS: This international, double-blind, phase 3 trial randomized pts 1:1 to DARO 600 mg twice daily or PBO in addition to ADT + docetaxel. The primary endpoint was overall survival (OS). Key secondary endpoints included time to castration-resistant prostate cancer (CRPC) and safety. RESULTS: Of 1305 pts analyzed, 244 (18.7%) were enrolled in North America (US/Canada 218/26; DARO/PBO 125/119) and of these, 36 (14.8%) were Black/African American (AA) pts. Baseline characteristics of the NA population were generally similar to those of the overall population, except for the proportion of pts with de novo metastatic disease (75.8% NA vs 86.1% overall). In NA pts, DARO + ADT + docetaxel was associated with OS benefit vs PBO + ADT + docetaxel (HR 0.59, 95% CI 0.39–0.89), with 4-year survival rates of 66% vs 50%, respectively. The DARO vs PBO group had longer time to CRPC (HR 0.32, 95% CI 0.21–0.48). The safety profile of DARO in NA pts was consistent with that of the overall population (grade 3/4 treatment-emergent adverse events [TEAEs] 61% NA vs 66% overall; serious TEAEs 44% NA vs 45% overall). The incidences of TEAEs associated with androgen receptor pathway inhibition for DARO vs PBO were generally consistent, particularly when adjusted for treatment exposure. The OS benefit and safety profile of DARO vs PBO was also seen in Black/AA pts, consistent with the overall population. CONCLUSIONS: In NA pts with mHSPC, addition of DARO to ADT + docetaxel led to a clinically meaningful reduction in risk of death by 41% and improved the key patient-relevant secondary endpoint of time to CRPC. Incidences of TEAEs were generally similar between treatment groups in NA pts and consistent with the overall population. Source of Funding: Bayer AG and Orion Pharma. © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e380 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Neal D. Shore More articles by this author Bertrand Tombal More articles by this author Maha Hussain More articles by this author Fred Saad More articles by this author Karim Fizazi More articles by this author Cora N. Sternberg More articles by this author E. David Crawford More articles by this author Luke Nordquist More articles by this author Ronald Tutrone More articles by this author Laurence Belkoff More articles by this author Shivani Kapur More articles by this author Jay Jhaveri More articles by this author Shankar Srinivasan More articles by this author Heikki Joensuu More articles by this author Matthew R. Smith More articles by this author Expand All Advertisement PDF downloadLoading ...