Pd01-03 Third Interim Analysis (Ia3) of the Darolutamide Observational (Darol) Study in Patients With Nonmetastatic Castration-Resistant Prostate Cancer (Nmcrpc)

You have accessJournal of UrologyProstate Cancer: Advanced (including Drug Therapy) I (PD01)1 May 2024PD01-03 THIRD INTERIM ANALYSIS (IA3) OF THE DAROLUTAMIDE OBSERVATIONAL (DAROL) STUDY IN PATIENTS WITH NONMETASTATIC CASTRATION-RESISTANT PROSTATE CANCER (NMCRPC) Geoffrey Gotto, Hiroyoshi Suzuki, Murilo Luz, Alberto Briganti, Evan Y. Yu, Christopher Pieczonka, Declan Murphy, Ryan Malone, Joelle Hamilton, Jonathan E. Chan, Paul Sieber, Robert W. Given, Patrick Adorjan, Mercedeh Ghadessi, Frank Verholen, and Andrew J. Armstrong Geoffrey GottoGeoffrey Gotto , Hiroyoshi SuzukiHiroyoshi Suzuki , Murilo LuzMurilo Luz , Alberto BrigantiAlberto Briganti , Evan Y. YuEvan Y. Yu , Christopher PieczonkaChristopher Pieczonka , Declan MurphyDeclan Murphy , Ryan MaloneRyan Malone , Joelle HamiltonJoelle Hamilton , Jonathan E. ChanJonathan E. Chan , Paul SieberPaul Sieber , Robert W. GivenRobert W. Given , Patrick AdorjanPatrick Adorjan , Mercedeh GhadessiMercedeh Ghadessi , Frank VerholenFrank Verholen , and Andrew J. ArmstrongAndrew J. Armstrong View All Author Informationhttps://doi.org/10.1097/01.JU.0001009540.33579.43.03AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: In ARAMIS (NCT02200614; phase 3), darolutamide (DARO) significantly improved metastasis-free survival (MFS) by ∼2 yrs and reduced the risk of death by 31% vs placebo in patients (pts) with nmCRPC, with a favorable tolerability profile. DAROL (NCT04122976) is assessing the real-world safety and effectiveness of DARO in pts with nmCRPC. We report results from the prespecified IA3. METHODS: DAROL is an ongoing, global, open-label, single-arm, non-interventional study in pts aged ≥18 yrs with nmCRPC for whom the decision to be treated with DARO was decided pre-enrollment. The primary endpoint is safety, including incidence and severity of treatment-emergent adverse events (TEAEs). Secondary endpoints include MFS, overall survival (OS), prostate-specific antigen (PSA) progression, and PSA response. Prespecified IA3 was conducted when 550 patients completed≥6 mo of treatment (data cut-off, July 17 2023). All treated pts were assessed for safety, and effectiveness was evaluated in pts who did not violate any eligibility criteria and had≥1 post-baseline (BL) assessment. RESULTS: Of 550 treated pts in IA3, 36%/35%/28%/2% were from Europe/North America/Asia Pacific/Latin America, respectively. Median age was 79 yrs (IQR 73–84); 48.5% had a Gleason score≥8; 80.7% had ECOG performance status 0/1. Median BL PSA was 4 ng/mL (IQR 2.3–9.3), with 18.7% of pts having PSA <2 ng/mL. Median PSA doubling time (PSADT) was 5.3 mo (IQR 3.1–8.9), and 175/394 pts (44.4%) with evaluable PSADT had PSADT≥6 mo. Median follow-up time was 16.5 mo (IQR 12.5–23.1), and median treatment duration was 14.9 mo (IQR 10.4–20.9). Incidences of TEAEs and DARO-related TEAEs were generally low (Table 1), consistent with results in ARAMIS. OS and MFS rates at 2 years were 87.6% (95% CI 82.3–91.4) and 78.3% (95% CI 72.7–83.0), respectively; overall PSA progression-free rate at 2 yrs was 85.3% (95% CI 79.5–89.5), and 79.4%, 76.0% and 53.8% pts had PSA30, PSA50, and PSA90 responses, respectively, at any time. CONCLUSIONS: In DAROL, MFS, OS, and PSA outcomes indicated effectiveness in the real-world setting, consistent with ARAMIS. Darolutamide showed no new safety signals in this study. Source of Funding: Bayer AG © 2024 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 211Issue 5SMay 2024Page: e63 Advertisement Copyright & Permissions© 2024 by American Urological Association Education and Research, Inc.Metrics Author Information Geoffrey Gotto More articles by this author Hiroyoshi Suzuki More articles by this author Murilo Luz More articles by this author Alberto Briganti More articles by this author Evan Y. Yu More articles by this author Christopher Pieczonka More articles by this author Declan Murphy More articles by this author Ryan Malone More articles by this author Joelle Hamilton More articles by this author Jonathan E. Chan More articles by this author Paul Sieber More articles by this author Robert W. Given More articles by this author Patrick Adorjan More articles by this author Mercedeh Ghadessi More articles by this author Frank Verholen More articles by this author Andrew J. Armstrong More articles by this author Expand All Advertisement PDF downloadLoading ...