LBA03-08 PEMBROLIZUMAB (PEMBRO) FOR PATIENTS (PTS) WITH HIGH-RISK NON-MUSCLE-INVASIVE BLADDER CANCER (HR NMIBC) UNRESPONSIVE TO BACILLUS CALMETTE-GUERIN (BCG): EFFICACY AND EVALUATION OF SUBSEQUENT CYSTECTOMY FROM COHORT B OF THE PHASE 2 KEYNOTE-057 STUDY (2023)

You have accessJournal of UrologyCME1 Apr 2023LBA03-08 PEMBROLIZUMAB (PEMBRO) FOR PATIENTS (PTS) WITH HIGH-RISK NON-MUSCLE-INVASIVE BLADDER CANCER (HR NMIBC) UNRESPONSIVE TO BACILLUS CALMETTE-GUERIN (BCG): EFFICACY AND EVALUATION OF SUBSEQUENT CYSTECTOMY FROM COHORT B OF THE PHASE 2 KEYNOTE-057 STUDY Eric Singer, Andrea Necchi, Mathieu Roumiguié, Ahmet Adil Esen, Thierry Lebret, Ronald de Wit, Dean F. Bajorin, Laurence E. M. Krieger, Shuya Kandori, Edward M. Uchio, Ho Kyung Seo, Joost Boormans, Ashish M. Kamat, Petros Grivas, Hiroyuki Nishiyama, Pranshu Baranwal, Ekta Kapadia, Margot Van den Sigtenhorst-Fijlstra, Girish S. Kulkarni, and Neal D. Shore Eric SingerEric Singer More articles by this author , Andrea NecchiAndrea Necchi More articles by this author , Mathieu RoumiguiéMathieu Roumiguié More articles by this author , Ahmet Adil EsenAhmet Adil Esen More articles by this author , Thierry LebretThierry Lebret More articles by this author , Ronald de WitRonald de Wit More articles by this author , Dean F. BajorinDean F. Bajorin More articles by this author , Laurence E. M. KriegerLaurence E. M. Krieger More articles by this author , Shuya KandoriShuya Kandori More articles by this author , Edward M. UchioEdward M. Uchio More articles by this author , Ho Kyung SeoHo Kyung Seo More articles by this author , Joost BoormansJoost Boormans More articles by this author , Ashish M. KamatAshish M. Kamat More articles by this author , Petros GrivasPetros Grivas More articles by this author , Hiroyuki NishiyamaHiroyuki Nishiyama More articles by this author , Pranshu BaranwalPranshu Baranwal More articles by this author , Ekta KapadiaEkta Kapadia More articles by this author , Margot Van den Sigtenhorst-FijlstraMargot Van den Sigtenhorst-Fijlstra More articles by this author , Girish S. KulkarniGirish S. Kulkarni More articles by this author , and Neal D. ShoreNeal D. Shore More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003426.08AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Cohort B of the phase 2 KEYNOTE-057 (NCT02625961) study evaluated pts with BCG-unresponsive HR NMIBC with papillary tumors (no carcinoma in situ [C-IS]) who were ineligible for or declined radical cystectomy (RC). Herein we present the primary efficacy results and outcomes of pts who underwent subsequent cystectomy. METHODS: Pts aged ≥18 y with BCG-unresponsive HR NMIBC with papillary tumors only (high-grade Ta or any-grade T1) at baseline and ECOG PS score of 0-2 received pembro 200 mg every 3 wk for ≤35 cycles (∼2 y). Primary end points for cohort B were 12-mo disease-free survival (DFS) rate of HR NMIBC by central pathology/radiology review and safety. Secondary efficacy end points included 12-mo DFS rate of any disease (low-grade Ta, HR disease, and progressive disease). Time to RC and pathologic staging at time of RC were evaluated. RESULTS: A total of 132 pts were enrolled with a median (range) of 10.0 (6.0-33.0) prior BCG instillations; 57 pts (43.2%) had T1 disease, and 75 pts (56.8%) had high-grade Ta disease. Pts received a median (range) of 9.5 cycles (1.0-35.0) of pembro. Median (range) follow-up was 45.4 mo (14.9-77.1). The 12-mo DFS rate of HR NMIBC was 43.5% (95% CI, 34.9-51.9); 12-mo DFS rate of any disease was 41.7% (33.1-50.0). Treatment-related AEs occurred in 97 pts (73.5%); 19 pts (14.4%) had a grade 3/4 treatment-related AE. No deaths from treatment-related AEs occurred. A total of 36 pts (28.3%) underwent RC after stopping pembro; 8 pts (18.6%) achieved initial disease-free status and 28 (45.9%) did not. Median (range) time from last dose of pembro to RC was 6.5 mo (1.0-16.0) for those who achieved initial DFS status and 2.8 mo (0.3-30.0) for those who did not. Pathologic staging at RC is presented (Table). Of 36 pts who underwent RC, 4 known pts (11.1%) had upstaging to MIBC; none of these pts experienced an initial disease-free status. CONCLUSIONS: After approximately 45 mo of follow-up, pembro monotherapy demonstrated antitumor activity in pts with BCG-unresponsive non-CIS papillary NMIBC. Rates of upstaging at time of RC are consistent with previous reports, suggesting that the window of opportunity for subsequent curative RC is generally preserved. Source of Funding: Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e1195 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Eric Singer More articles by this author Andrea Necchi More articles by this author Mathieu Roumiguié More articles by this author Ahmet Adil Esen More articles by this author Thierry Lebret More articles by this author Ronald de Wit More articles by this author Dean F. Bajorin More articles by this author Laurence E. M. Krieger More articles by this author Shuya Kandori More articles by this author Edward M. Uchio More articles by this author Ho Kyung Seo More articles by this author Joost Boormans More articles by this author Ashish M. Kamat More articles by this author Petros Grivas More articles by this author Hiroyuki Nishiyama More articles by this author Pranshu Baranwal More articles by this author Ekta Kapadia More articles by this author Margot Van den Sigtenhorst-Fijlstra More articles by this author Girish S. Kulkarni More articles by this author Neal D. Shore More articles by this author Expand All Advertisement PDF downloadLoading ...