P2-04 EFFICACY OF [ ¹⁷⁷ Lu]Lu-PSMA-617 VERSUS ARPI CHANGE IN TAXANE-NAIVE PATIENTS WITH METASTATIC CASTRATION-RESISTANT PROSTATE CANCER BY PRE-RANDOMIZATION ARPI (PSMAFORE)

You have accessJournal of UrologyParadigm-shifting, Practice-changing Clinical Trials in Urology (P2)1 May 2024P2-04 EFFICACY OF [177Lu]Lu-PSMA-617 VERSUS ARPI CHANGE IN TAXANE-NAIVE PATIENTS WITH METASTATIC CASTRATION-RESISTANT PROSTATE CANCER BY PRE-RANDOMIZATION ARPI (PSMAFORE) Neal Shore, Kim N. Chi, Michael J. Morris, Oliver Sartor, Karim Fizazi, Aude Fléchon, Hana Študentová, Hyun Kim, Teri N. Kreisl, Samson Ghebremariam, Marianna Hertelendi, Fred Saad, and Xiao X. Wei Neal ShoreNeal Shore , Kim N. ChiKim N. Chi , Michael J. MorrisMichael J. Morris , Oliver SartorOliver Sartor , Karim FizaziKarim Fizazi , Aude FléchonAude Fléchon , Hana ŠtudentováHana Študentová , Hyun KimHyun Kim , Teri N. KreislTeri N. Kreisl , Samson GhebremariamSamson Ghebremariam , Marianna HertelendiMarianna Hertelendi , Fred SaadFred Saad , and Xiao X. WeiXiao X. Wei View All Author Informationhttps://doi.org/10.1097/01.JU.0001015816.87470.c9.04AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: In the phase 3 PSMAfore study (NCT04689828), [177Lu]Lu-PSMA-617 (177Lu-PSMA-617) prolonged radiographic progression-free survival (rPFS) versus androgen receptor pathway inhibitor (ARPI) change in patients naive to taxane chemotherapy with prostate-specific membrane antigen (PSMA) positive metastatic castration-resistant prostate cancer (mCRPC; HR 0.41; 95% CI 0.29–0.56; p<0.0001). We now present an exploratory post hoc analysis of efficacy outcomes by pre-randomization ARPI treatment at the second interim overall survival (OS) analysis. METHODS: Eligible adults had mCRPC, were suitable for ARPI change after one progression on prior ARPI and had ≥1 PSMA-positive lesion and no exclusionary PSMA-negative lesions by [68Ga]Ga-PSMA-11 PET/CT. Ineligible patients were candidates for PARP inhibition or had received prior systemic/hemibody radiotherapy, immunotherapy or chemotherapy. Randomization was 1:1 to open-label 177Lu-PSMA-617 (7.4 GBq Q6W; 6 cycles) or ARPI change (abiraterone/enzalutamide). Endpoints included rPFS (BICR per PCWG3/RECIST v1.1; primary), OS (key secondary), PSA50 response (prostate-specific antigen [PSA] decline ≥50% from baseline; secondary) and objective response rate (ORR; exploratory). Median rPFS was estimated using the Kaplan–Meier method and HRs were obtained using the Cox proportional hazards model. Descriptive statistics were used for PSA50 response and ORR. RESULTS: Of the 234 patients randomized per arm, 50.9% and 40.2% randomized to 177Lu-PSMA-617, and 55.6% and 35.9% randomized to ARPI change received pre-randomization abiraterone and enzalutamide, respectively. 177Lu-PSMA-617 prolonged rPFS versus ARPI change regardless of pre-randomization ARPI; PSA50 responses and ORR also favored the 177Lu-PSMA-617 arm. In both arms, more favorable results were observed in patients receiving pre-randomization abiraterone than enzalutamide (Table 1). CONCLUSIONS: 177Lu-PSMA-617 prolonged rPFS and increased PSA50 responses and ORR versus ARPI change in taxane-naive patients with PSMA-positive mCRPC, regardless of pre-randomization ARPI. Results favored patients receiving pre-randomization abiraterone versus enzalutamide. Source of Funding: Novartis © 2024 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 211Issue 5S2May 2024Page: e2 Advertisement Copyright & Permissions© 2024 by American Urological Association Education and Research, Inc.Metrics Author Information Neal Shore More articles by this author Kim N. Chi More articles by this author Michael J. Morris More articles by this author Oliver Sartor More articles by this author Karim Fizazi More articles by this author Aude Fléchon More articles by this author Hana Študentová More articles by this author Hyun Kim More articles by this author Teri N. Kreisl More articles by this author Samson Ghebremariam More articles by this author Marianna Hertelendi More articles by this author Fred Saad More articles by this author Xiao X. Wei More articles by this author Expand All Advertisement PDF downloadLoading ...