PD09-10 AVELUMAB FIRST-LINE (1L) MAINTENANCE FOR ADVANCED UROTHELIAL CARCINOMA (UC): LONG-TERM OUTCOMES FROM JAVELIN BLADDER 100 IN SUBGROUPS DEFINED BY RESPONSE TO 1L CHEMOTHERAPY

Abstract

You have accessJournal of UrologyCME1 Apr 2023PD09-10 AVELUMAB FIRST-LINE (1L) MAINTENANCE FOR ADVANCED UROTHELIAL CARCINOMA (UC): LONG-TERM OUTCOMES FROM JAVELIN BLADDER 100 IN SUBGROUPS DEFINED BY RESPONSE TO 1L CHEMOTHERAPY Begoña Valderrama, Thomas Powles, Srikala Sridhar, Claudia Caserta, Yohann Loriot, Shilpa Gupta, Joaquim Bellmunt, Cora Sternberg, Jing Wang, Nuno Costa, Robert Laliberte, Alessandra di Pietro, Se Hoon Park, and Petros Grivas Begoña ValderramaBegoña Valderrama More articles by this author , Thomas PowlesThomas Powles More articles by this author , Srikala SridharSrikala Sridhar More articles by this author , Claudia CasertaClaudia Caserta More articles by this author , Yohann LoriotYohann Loriot More articles by this author , Shilpa GuptaShilpa Gupta More articles by this author , Joaquim BellmuntJoaquim Bellmunt More articles by this author , Cora SternbergCora Sternberg More articles by this author , Jing WangJing Wang More articles by this author , Nuno CostaNuno Costa More articles by this author , Robert LaliberteRobert Laliberte More articles by this author , Alessandra di PietroAlessandra di Pietro More articles by this author , Se Hoon ParkSe Hoon Park More articles by this author , and Petros GrivasPetros Grivas More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003240.10AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: In the phase 3 JAVELIN Bladder 100 trial (NCT02603432), avelumab 1L maintenance+best supportive care (BSC) significantly prolonged overall survival (OS) vs BSC alone in patients with advanced UC that had not progressed with 1L platinum-based chemotherapy. We report exploratory analyses in subgroups defined by response to 1L chemotherapy (complete response [CR], partial response [PR], or stable disease [SD]) after ≥2 years of follow-up. METHODS: Eligible patients had unresectable locally advanced or metastatic UC without progression with 4-6 cycles of 1L gemcitabine+cisplatin or carboplatin. Patients were randomized 1:1 to receive avelumab+BSC (n=350) or BSC alone (n=350), stratified by best response to 1L chemotherapy (CR/PR vs SD) and visceral vs nonvisceral disease at start of 1L chemotherapy. RESULTS: At data cutoff (June 4, 2021), median follow-up in both arms was ≥38 months. OS and PFS were longer in the avelumab+BSC vs BSC alone arm in all subgroups (Table 1). Median duration of study treatment and incidence of grade ≥3 treatment-emergent adverse events (TEAEs) in subgroups are shown in the Table 1. In the avelumab+BSC vs BSC alone arm, respectively, subsequent second-line anticancer drug therapy was received by: CR subgroup, 50.0% vs 74.2%; PR subgroup, 58.3% vs 71.8%; and SD subgroup, 46.4% vs 70.4%. CONCLUSIONS: Long-term follow-up from JAVELIN Bladder 100 continues to show prolonged OS and PFS with avelumab+BSC vs BSC alone irrespective of response (CR, PR, or SD) to 1L chemotherapy and despite a higher proportion of patients in the BSC alone arm receiving subsequent therapy. Long-term safety was consistent across subgroups. These findings further support avelumab 1L maintenance as standard of care for all patients with advanced UC that has not progressed with 1L platinum-based chemotherapy. © 2022 American Society of Clinical Oncology, Inc. Reused with permission. This abstract was accepted and previously presented at the 2022 ASCO Annual Meeting. All rights reserved. Source of Funding: This trial was sponsored by Pfizer as part of an alliance between Pfizer and the healthcare business of Merck KGaA, Darmstadt, Germany (CrossRef Funder ID: 10.13039/100009945). Medical writing support was provided by Jamie Ratcliffe of ClinicalThinking and was funded by Pfizer and the healthcare business of Merck KGaA, Darmstadt, Germany © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e244 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Begoña Valderrama More articles by this author Thomas Powles More articles by this author Srikala Sridhar More articles by this author Claudia Caserta More articles by this author Yohann Loriot More articles by this author Shilpa Gupta More articles by this author Joaquim Bellmunt More articles by this author Cora Sternberg More articles by this author Jing Wang More articles by this author Nuno Costa More articles by this author Robert Laliberte More articles by this author Alessandra di Pietro More articles by this author Se Hoon Park More articles by this author Petros Grivas More articles by this author Expand All Advertisement PDF downloadLoading ...