Mp63-05 outcomes in patients (pts) with bacillus calmette-guerin (bcg)-unresponsive high-risk (hr) non-muscle-invasive bladder cancer (nmibc) who underwent radical cystectomy (rc) following pembrolizumab (pembro) treatment in keynote-057 cohort a

You have accessJournal of UrologyCME1 Apr 2023MP63-05 OUTCOMES IN PATIENTS (PTS) WITH BACILLUS CALMETTE-GUERIN (BCG)-UNRESPONSIVE HIGH-RISK (HR) NON-MUSCLE-INVASIVE BLADDER CANCER (NMIBC) WHO UNDERWENT RADICAL CYSTECTOMY (RC) FOLLOWING PEMBROLIZUMAB (PEMBRO) TREATMENT IN KEYNOTE-057 COHORT A Girish S. Kulkarni, Ashish M. Kamat, Edward M. Uchio, Mathieu Roumiguié, Laurence E. M. Krieger, Eric A. Singer, Dean F. Bajorin, Petros Grivas, Ho Kyung Seo, Hiroyuki Nishiyama, Badrinath R. Konety, Ronald de Wit, Ekta Kapadia, Aiwen Xing, Margot Van den Sigtenhorst Fijlstra, and Joost L. Boormans Girish S. KulkarniGirish S. Kulkarni More articles by this author , Ashish M. KamatAshish M. Kamat More articles by this author , Edward M. UchioEdward M. Uchio More articles by this author , Mathieu RoumiguiéMathieu Roumiguié More articles by this author , Laurence E. M. KriegerLaurence E. M. Krieger More articles by this author , Eric A. SingerEric A. Singer More articles by this author , Dean F. BajorinDean F. Bajorin More articles by this author , Petros GrivasPetros Grivas More articles by this author , Ho Kyung SeoHo Kyung Seo More articles by this author , Hiroyuki NishiyamaHiroyuki Nishiyama More articles by this author , Badrinath R. KonetyBadrinath R. Konety More articles by this author , Ronald de WitRonald de Wit More articles by this author , Ekta KapadiaEkta Kapadia More articles by this author , Aiwen XingAiwen Xing More articles by this author , Margot Van den Sigtenhorst FijlstraMargot Van den Sigtenhorst Fijlstra More articles by this author , and Joost L. BoormansJoost L. Boormans More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003321.05AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Cohort A of KEYNOTE-057 (NCT02625961) showed durable antitumor activity and manageable toxicity with pembro in pts with BCG-unresponsive HR NMIBC with carcinoma in situ (CIS)±papillary disease. We explored outcomes of pts in KEYNOTE-057 cohort A who underwent RC after discontinuing pembro. METHODS: Eligible adults with histologically confirmed BCG-unresponsive HR NMIBC with CIS±high-grade Ta or T1 tumor and predominantly urothelial histology who were ineligible for or declined RC received pembro 200 mg IV Q3W for ≤2 yrs. Primary end point: complete response (CR) rate; secondary end point was DOR. Cystectomy-free survival (CFS), calculated from first dose of pembro, was evaluated in all pts to compare CFS between complete responders vs non–complete responders. Time to cystectomy and pathologic staging at time of RC were evaluated. RESULTS: As of May 25, 2022, median follow-up for 96 enrolled pts was 60.4 mo (range, 50.2-72.5). CR rate was 41% (n=39) at 3 mo, and median DOR was 16.2 mo (range, 0.0+ to 57.7+). Median CFS was 56.8 mo (95% CI, 30.9-NR) for pts with CR and 18.5 mo (95% CI, 7.8-36.5) for pts without CR. Out of 96 enrolled pts, 43 underwent RC after discontinuing pembro (12 with initial CR followed by recurrence/progression and 31 without CR). Median time to RC from first dose of pembro was 9.0 mo (range, 4.0-41.8) for all pts who underwent RC, 14.3 mo (range, 9.0-32.5) for pts with initial CR, and 6.4 mo (range, 4.0-41.8) for pts without CR. Pathologic staging results are presented (table). Of 43 pts who underwent RC, 5 (12%) had upstaging to MIBC, of whom 4 never achieved CR and 1 achieved initial CR. Pts who developed ≥pT3 disease underwent RC >1 year after last dose of pembro. CONCLUSIONS: This exploratory analysis suggests that pembro may result in a clinically meaningful delay in RC in pts with BCG-unresponsive HR NMIBC with CIS, especially in pts who achieve an initial CR. Rates of upstaging at time of RC among pts who do not achieve a CR with pembro are generally consistent with previous reports of pts who undergo immediate RC, suggesting that the window of opportunity for subsequent RC is largely 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: e872 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Girish S. Kulkarni More articles by this author Ashish M. Kamat More articles by this author Edward M. Uchio More articles by this author Mathieu Roumiguié More articles by this author Laurence E. M. Krieger More articles by this author Eric A. Singer More articles by this author Dean F. Bajorin More articles by this author Petros Grivas More articles by this author Ho Kyung Seo More articles by this author Hiroyuki Nishiyama More articles by this author Badrinath R. Konety More articles by this author Ronald de Wit More articles by this author Ekta Kapadia More articles by this author Aiwen Xing More articles by this author Margot Van den Sigtenhorst Fijlstra More articles by this author Joost L. Boormans More articles by this author Expand All Advertisement PDF downloadLoading ...