Pd38-02 Avelumab First-Line Maintenance for Advanced Urothelial Carcinoma: Long-Term Outcomes From Javelin Bladder 100 in Subgroups Defined by First-Line Chemotherapy Regimen and Analysis of Overall Survival From Start of First-Line Chemotherapy

You have accessJournal of UrologyBladder Cancer: Invasive IV (PD38)1 May 2024PD38-02 AVELUMAB FIRST-LINE MAINTENANCE FOR ADVANCED UROTHELIAL CARCINOMA: LONG-TERM OUTCOMES FROM JAVELIN BLADDER 100 IN SUBGROUPS DEFINED BY FIRST-LINE CHEMOTHERAPY REGIMEN AND ANALYSIS OF OVERALL SURVIVAL FROM START OF FIRST-LINE CHEMOTHERAPY Srikala S. Sridhar, Thomas Powles, Shilpa Gupta, Miguel A. Climent Duran, Jeanny B. Aragon-Ching, Cora N. Sternberg, Paul Cislo, Nuno Costa, Alessandra di Pietro, Joaquim Bellmunt, and Petros Grivas Srikala S. SridharSrikala S. Sridhar , Thomas PowlesThomas Powles , Shilpa GuptaShilpa Gupta , Miguel A. Climent DuranMiguel A. Climent Duran , Jeanny B. Aragon-ChingJeanny B. Aragon-Ching , Cora N. SternbergCora N. Sternberg , Paul CisloPaul Cislo , Nuno CostaNuno Costa , Alessandra di PietroAlessandra di Pietro , Joaquim BellmuntJoaquim Bellmunt , and Petros GrivasPetros Grivas View All Author Informationhttps://doi.org/10.1097/01.JU.0001009424.64728.0c.02AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: In the phase 3 JAVELIN Bladder 100 trial (NCT02603432), avelumab first-line (1L) maintenance + best supportive care (BSC) significantly prolonged overall survival (OS) and progression-free survival (PFS) from start of maintenance (randomization) vs BSC alone in patients (pts) with advanced urothelial carcinoma (UC) without progression after 1L platinum-based chemotherapy (median OS, 23.8 vs 15.0 months; HR, 0.76 95% CI, 0.63-0.91; p=0.0036). We report post hoc analyses of long-term outcomes by 1L chemotherapy and OS from start of 1L chemotherapy. METHODS: Pts with unresectable locally advanced or metastatic UC without progression after 4-6 cycles of 1L cisplatin or carboplatin + gemcitabine were enrolled (N=700). The primary endpoint was OS measured from randomization. RESULTS: At data cutoff (June 4, 2021), median follow-up from randomization was≥38 months in both arms. In subgroups treated with 1L cisplatin + gemcitabine or carboplatin + gemcitabine, OS and PFS (measured from randomization) were longer with avelumab + BSC vs BSC alone (Table 1). Safety findings were similar in both subgroups. In the overall population, median OS (95% CI) measured from the start of 1L chemotherapy in this population without progression after 1L chemotherapy was 29.7 months (25.2-34.0) with avelumab + BSC and 20.5 months (19.0-23.5) with BSC alone (HR, 0.77 95% CI, 0.635-0.921). CONCLUSIONS: Long-term outcomes from JAVELIN Bladder 100 confirm that avelumab 1L maintenance provides similar OS and PFS benefits with acceptable safety in pts with advanced UC without progression after 1L cisplatin- or carboplatin-based chemotherapy. The median OS measured from start of chemotherapy further supports the use of avelumab 1L maintenance as standard of care in this setting and provides a benchmark for future clinical trials. © 2023 American Society of Clinical Oncology, Inc. Reused with permission. This abstract was accepted and previously presented at the 2023 ASCO Genitourinary Cancers Symposium. All rights reserved. Source of Funding: This study was sponsored by Pfizer and was previously conducted under an alliance between the healthcare business of Merck KGaA, Darmstadt, Germany (CrossRef Funder ID: 10.13039/100009945) and Pfizer. Medical writing support was provided by Amy Davidson of Clinical Thinking and was funded by the healthcare business of Merck KGaA, Darmstadt, Germany and Pfizer © 2024 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 211Issue 5SMay 2024Page: e806 Advertisement Copyright & Permissions© 2024 by American Urological Association Education and Research, Inc.Metrics Author Information Srikala S. Sridhar More articles by this author Thomas Powles More articles by this author Shilpa Gupta More articles by this author Miguel A. Climent Duran More articles by this author Jeanny B. Aragon-Ching More articles by this author Cora N. Sternberg More articles by this author Paul Cislo More articles by this author Nuno Costa More articles by this author Alessandra di Pietro More articles by this author Joaquim Bellmunt More articles by this author Petros Grivas More articles by this author Expand All Advertisement PDF downloadLoading ...