Pd55-01 avelumab first-line maintenance for advanced urothelial carcinoma in the javelin bladder 100 trial: subgroup analysis by duration of treatment-free interval from end of chemotherapy to start of maintenance

You have accessJournal of UrologyBladder Cancer: Invasive IV (PD55)1 Sep 2021PD55-01 AVELUMAB FIRST-LINE MAINTENANCE FOR ADVANCED UROTHELIAL CARCINOMA IN THE JAVELIN BLADDER 100 TRIAL: SUBGROUP ANALYSIS BY DURATION OF TREATMENT-FREE INTERVAL FROM END OF CHEMOTHERAPY TO START OF MAINTENANCE Srikala S. Sridhar, Thomas Powles, Yohann Loriot, Miguel A. Climent Durán, Shilpa Gupta, Norihiko Tsuchiya, Aristotelis Bamias, Andrea Ardizzoni, Anders Ullén, Bo Huang, Nuno Costa, Robert J Laliberte, Alessandra di Pietro, Cora N Sternberg, and Petros Grivas Srikala S. SridharSrikala S. Sridhar More articles by this author , Thomas PowlesThomas Powles More articles by this author , Yohann LoriotYohann Loriot More articles by this author , Miguel A. Climent DuránMiguel A. Climent Durán More articles by this author , Shilpa GuptaShilpa Gupta More articles by this author , Norihiko TsuchiyaNorihiko Tsuchiya More articles by this author , Aristotelis BamiasAristotelis Bamias More articles by this author , Andrea ArdizzoniAndrea Ardizzoni More articles by this author , Anders UllénAnders Ullén More articles by this author , Bo HuangBo Huang More articles by this author , Nuno CostaNuno Costa More articles by this author , Robert J LaliberteRobert J Laliberte More articles by this author , Alessandra di PietroAlessandra di Pietro More articles by this author , Cora N SternbergCora N Sternberg More articles by this author , and Petros GrivasPetros Grivas More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002089.01AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: The phase 3 JAVELIN Bladder 100 trial (NCT02603432), which enrolled patients (pts) with advanced urothelial carcinoma (UC) that had not progressed with first-line (1L) platinum-based chemotherapy, showed that avelumab 1L maintenance + best supportive care (BSC) significantly prolonged overall survival (OS) vs BSC alone (hazard ratio [HR], 0.69 [95% CI: 0.56, 0.86; 1-sided P=0.0005]). The optimal timing for starting avelumab after completing 1L chemotherapy is unknown. We report a post hoc analysis of efficacy by duration of treatment-free interval (TFI) from end of 1L chemotherapy. METHODS: Eligible pts had unresectable locally advanced or metastatic UC that had not progressed with 4-6 cycles of 1L platinum-based chemotherapy. Pts were randomized to receive avelumab + BSC (n=350) or BSC alone (n=350) after a TFI of 4-10 wks from last dose of chemotherapy. In this exploratory analysis, subgroups with a TFI of 4 to <6 wks (<42 d), 6 to <8 wks (42 to <56 d), or 8 to 10 wks (≥56 d) were evaluated. RESULTS: In the avelumab + BSC and BSC alone arms, TFI was 4 to <6 wks in 143 and 158 pts, 6 to <8 wks in 109 and 80 pts, and 8 to 10 wks in 98 and 110 pts, respectively. Baseline characteristics in subgroups were generally well balanced between arms. For both arms combined, however, the TFI 4 to <6 wks subgroup vs other subgroups included more pts with visceral metastases (57.8% vs 54.0% and 50.0%), objective response with 1L chemotherapy (76.4% vs 69.3% and 68.3%), and ECOG performance status of 1 (44.5% vs 33.3% and 35.6%). OS was prolonged with avelumab + BSC vs BSC alone in all subgroups; the HR was 0.76 (95% CI: 0.546, 1.059) in the TFI 4 to <6 wks subgroup (median OS [95% CI], 19.9 mos [16.3, 25.3] vs 13.5 mos [11.7, 17.4]), 0.64 (95% CI: 0.404, 1.021) in the TFI 6 to <8 wks subgroup (median OS [95% CI], 26.1 mos [19.9, not estimable (NE)] vs 21.0 mos [10.7, NE]), and 0.70 (95% CI: 0.468, 1.035) in the TFI 8 to 10 wks subgroup (median OS [95% CI], 20.1 mos [13.8, NE] vs 14.1 mos [11.7, 19.6]). CONCLUSIONS: In pts with advanced UC that had not progressed with 1L platinum-based chemotherapy, avelumab 1L maintenance prolonged OS irrespective of the TFI assessed in this study (4-10 wks), supporting this new treatment strategy as a standard of care. Differences in duration of TFI were likely related to individual patient/disease-specific characteristics or logistics and did not impact the OS benefit observed with avelumab 1L maintenance. Source of Funding: Funded by Pfizer as part of an alliance between Merck KGaA, Darmstadt, Germany and Pfizer © 2021 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 206Issue Supplement 3September 2021Page: e997-e997 Advertisement Copyright & Permissions© 2021 by American Urological Association Education and Research, Inc.MetricsAuthor Information Srikala S. Sridhar More articles by this author Thomas Powles More articles by this author Yohann Loriot More articles by this author Miguel A. Climent Durán More articles by this author Shilpa Gupta More articles by this author Norihiko Tsuchiya More articles by this author Aristotelis Bamias More articles by this author Andrea Ardizzoni More articles by this author Anders Ullén More articles by this author Bo Huang More articles by this author Nuno Costa More articles by this author Robert J Laliberte More articles by this author Alessandra di Pietro More articles by this author Cora N Sternberg More articles by this author Petros Grivas More articles by this author Expand All Advertisement Loading ...