MP11-14 TREATMENT DURATION AND LONG-TERM SAFETY AND TOLERABILITY WITH DAROLUTAMIDE IN NONMETASTATIC CASTRATION-RESISTANT PROSTATE CANCER (nmCRPC): ARAMIS ROLLOVER STUDY

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You have accessJournal of UrologyCME1 Apr 2023MP11-14 TREATMENT DURATION AND LONG-TERM SAFETY AND TOLERABILITY WITH DAROLUTAMIDE IN NONMETASTATIC CASTRATION-RESISTANT PROSTATE CANCER (nmCRPC): ARAMIS ROLLOVER STUDY Neal D. Shore, Murilo Luz, Albertas Ulys, Jorge Ortiz, Shankar Srinivasan, Etah Kurland, and Karim Fizazi Neal D. ShoreNeal D. Shore More articles by this author , Murilo LuzMurilo Luz More articles by this author , Albertas UlysAlbertas Ulys More articles by this author , Jorge OrtizJorge Ortiz More articles by this author , Shankar SrinivasanShankar Srinivasan More articles by this author , Etah KurlandEtah Kurland More articles by this author , and Karim FizaziKarim Fizazi More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003226.14AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: In patients (pts) with nmCRPC, darolutamide (DARO) significantly improved metastasis-free survival by ∼2 years and reduced the risk of death by 31% vs placebo, with a favorable safety profile (ARAMIS study; NCT02200614). We report the long-term safety and tolerability of DARO in the ARAMIS Rollover Study (ROS; NCT04464226). METHODS: In ARAMIS, 954 pts received double-blind (DB) DARO 600 mg orally twice daily, of whom 591 pts continued on open-label (OL) DARO following the primary analysis. On completion of ARAMIS, 294 pts with no evidence of metastases and benefitting clinically from DARO entered the ROS. DARO treatment duration and safety are described for the 954 pts over the DB, DB+OL, and DB+OL+ROS periods. RESULTS: At data cut-off of Jan 31, 2022, the median (range) duration of DARO treatment was DB 1.5 years (0.0–4.0), DB+OL 2.1 years (0.0–4.9), and DB+OL+ROS 2.8 years (0.0–6.8). Of the 954 randomized pts, 32.3% received DARO treatment for ≥2–<4 years, 17.3% for ≥4–<5 years, and 12.8% for ≥5 years. As expected, cumulative incidences of treatment-emergent adverse events (TEAEs) increased slightly with longer observation time. For the DB, DB+OL, and DB+OL+ROS periods, respectively, TEAE incidences were: any grade 85.7%, 89.8%, 91.5%; grade 3/4 26.3%, 31.8%, 35.5%; serious 26.1%, 32.1%, 38.5%; and leading to treatment discontinuation 8.9%, 10.5%, 12.9%. Increases in incidences of TEAEs commonly associated with androgen receptor inhibition across the DB, DB+OL, and DB+OL+ROS periods were mostly minimal (Figure 1). During the first 24 months of DARO treatment, incidences of most of these TEAEs were low and ≤2% different vs placebo, except for fatigue. Onset of these TEAEs by time intervals across all study phases (DB, DB+OL, DB+OL+ROS) will be presented. CONCLUSIONS: Approximately 30% of pts with nmCRPC remained on DARO for ≥4 years, suggesting long-term clinical benefit. Most adverse events (AEs) occurred in the first 2 years of treatment, with small increments over time. The favorable safety profile of DARO was maintained with long-term exposure. No new safety concerns were observed in the ROS. Source of Funding: Bayer AG and Orion Pharma © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e129 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Neal D. Shore More articles by this author Murilo Luz More articles by this author Albertas Ulys More articles by this author Jorge Ortiz More articles by this author Shankar Srinivasan More articles by this author Etah Kurland More articles by this author Karim Fizazi More articles by this author Expand All Advertisement PDF downloadLoading ...