You have accessJournal of UrologyCME1 May 2022MP56-02 NEOADJUVANT PEMBROLIZUMAB MAY RESULT IN LONG-TERM OUTCOME IMPROVEMENT IN BIOMARKER-UNSELECTED PATIENTS WITH MUSCLE-INVASIVE BLADDER CANCER (MIBC): UPDATED RESULTS FROM PURE-01 Luigi Nocera, Marco Moschini, Daniele Raggi, Laura Marandino, Maurizio Colecchia, Roberta Lucianò, Ewan Gibb, Jeffrey Ross, Antonella Messina, Giuseppina Calareso, Andrea Gallina, Federico Dehò, Alberto Briganti, Francesco Montorsi, and Andrea Necchi Luigi NoceraLuigi Nocera More articles by this author , Marco MoschiniMarco Moschini More articles by this author , Daniele RaggiDaniele Raggi More articles by this author , Laura MarandinoLaura Marandino More articles by this author , Maurizio ColecchiaMaurizio Colecchia More articles by this author , Roberta LucianòRoberta Lucianò More articles by this author , Ewan GibbEwan Gibb More articles by this author , Jeffrey RossJeffrey Ross More articles by this author , Antonella MessinaAntonella Messina More articles by this author , Giuseppina CalaresoGiuseppina Calareso More articles by this author , Andrea GallinaAndrea Gallina More articles by this author , Federico DehòFederico Dehò More articles by this author , Alberto BrigantiAlberto Briganti More articles by this author , Francesco MontorsiFrancesco Montorsi More articles by this author , and Andrea NecchiAndrea Necchi More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002639.02AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: PURE-01 trial provided several activity signals mainly represented by pathological response endpoints. We aimed to report updated results on recurrence-free survival (RFS) and overall survival (OS) at longer follow-up. METHODS: From 02/2017 to 06/2020, 136 patients were treated. RFS was defined as the time from first pembrolizumab dose to either: i) radiological progression, ii) local or distant recurrence, iii) death from any cause. Statistical analyses consisted of Kaplan-Meier analyses and Cox regression models. RESULTS: Of all 136 patients, 120 (88%) were males and median age was 68 years (IQR 62-74), while 76 patients (56%) exhibited a PD-L1 CPS≥10% on the TURB specimen pre-therapy. At radical cystectomy pathology, 57 (42%), 25 (18%), 34 (25%) and 20 (15%) patients harbored respectively ypT0N0, ypT1/a/isN0, ypT2-4N0 and ypTanyN+ disease. Finally, 9 patients (7%) received also adjuvant chemotherapy: 3 ypT2-4N0 and 6 ypTanyN+ patients. After a median follow-up of 27 months (IQR 21-38), 22 patients (16%) experienced a recurrence, while 14 patients (10%) died. At Kaplan-Meier curves (Figure 1), patients treated with neoadjuvant pembrolizumab exhibited a 36-month OS of 95%, 86%, 93% and 56% for respectively ypT0N0, ypT1/a/isN0, ypT2-4N0 and ypTanyN+ stages. Similarly, they exhibited a 36-month RFS of 94%, 96%, 67% and 44% for respectively ypT0N0, ypT1/a/isN0, ypT2-4N0 and ypTanyN+ stages. In ITT population, 36-month RFS and OS for CPS≥10% vs CPS>10 cohorts were respectively 88% vs 72% and 91% vs 79%. At multivariable Cox regression analyses, only age (HR 1.1, p=0.02) and ypTanyN+ stage (HR 9.0, p=0.02) represented independent predictors of overall mortality, after adjustment for stage, CPS ≥10% and adjuvant chemotherapy. Similarly, when recurrence represented the outcome, only ypT2-4N0 (HR 8.6, p=0.007) and ypTanyN+ (HR 15.9, p=0.001) stages represented independent predictors. CONCLUSIONS: Pembrolizumab followed by radical cystectomy confirms to be an effective treatment for patients with MIBC, unselected for biomarkers and for cisplatin eligibility. This data should be tested towards the data emerging in adjuvant setting and in light of the ongoing randomized perioperative phase 3 trials. Source of Funding: NA © 2022 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 207Issue Supplement 5May 2022Page: e971 Advertisement Copyright & Permissions© 2022 by American Urological Association Education and Research, Inc.MetricsAuthor Information Luigi Nocera More articles by this author Marco Moschini More articles by this author Daniele Raggi More articles by this author Laura Marandino More articles by this author Maurizio Colecchia More articles by this author Roberta Lucianò More articles by this author Ewan Gibb More articles by this author Jeffrey Ross More articles by this author Antonella Messina More articles by this author Giuseppina Calareso More articles by this author Andrea Gallina More articles by this author Federico Dehò More articles by this author Alberto Briganti More articles by this author Francesco Montorsi More articles by this author Andrea Necchi More articles by this author Expand All Advertisement PDF DownloadLoading ...