Pd34-11 Nivolumab Plus Gemcitabine-Cisplatin Versus Gemcitabine-Cisplatin Alone in Patients With Previously Untreated Unresectable or Metastatic Urothelial Carcinoma: Results of Analyses to Characterize Benefit in Responders From the Phase 3 Checkmate 901 Trial

You have accessJournal of UrologyBladder Cancer: Invasive III (PD34)1 May 2024PD34-11 NIVOLUMAB PLUS GEMCITABINE-CISPLATIN VERSUS GEMCITABINE-CISPLATIN ALONE IN PATIENTS WITH PREVIOUSLY UNTREATED UNRESECTABLE OR METASTATIC UROTHELIAL CARCINOMA: RESULTS OF ANALYSES TO CHARACTERIZE BENEFIT IN RESPONDERS FROM THE PHASE 3 CHECKMATE 901 TRIAL Guru Sonpavde, Michiel S. van der Heijden, Thomas Powles, Andrea Necchi, Mauricio Burotto, Michael Schenker, Juan Pablo Sade, Aristotelis Bamias, Philippe Beuzeboc, Jens Bedke, Jan Oldenburg, Yüksel Ürün, Dingwei Ye, Begoña P. Valderrama, Yoshihiko Tomita, Jeiry Filian, Lily Wang, Daniela Purcea, Federico Nasroulah, and Matthew D. Galsky Guru SonpavdeGuru Sonpavde , Michiel S. van der HeijdenMichiel S. van der Heijden , Thomas PowlesThomas Powles , Andrea NecchiAndrea Necchi , Mauricio BurottoMauricio Burotto , Michael SchenkerMichael Schenker , Juan Pablo SadeJuan Pablo Sade , Aristotelis BamiasAristotelis Bamias , Philippe BeuzebocPhilippe Beuzeboc , Jens BedkeJens Bedke , Jan OldenburgJan Oldenburg , Yüksel ÜrünYüksel Ürün , Dingwei YeDingwei Ye , Begoña P. ValderramaBegoña P. Valderrama , Yoshihiko TomitaYoshihiko Tomita , Jeiry FilianJeiry Filian , Lily WangLily Wang , Daniela PurceaDaniela Purcea , Federico NasroulahFederico Nasroulah , and Matthew D. GalskyMatthew D. Galsky View All Author Informationhttps://doi.org/10.1097/01.JU.0001008768.36634.79.11AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: There have been no improvements to the first-line (1L) standard of care (SOC) for unresectable/metastatic urothelial carcinoma (mUC) with cisplatin (cis)-based chemotherapy (chemo) for decades. We report results from CheckMate 901 for nivolumab (NIVO) plus gemcitabine-cis (GC) or GC alone in patients (pts) with previously untreated mUC, including further characterization of pts who responded to treatment (tx). METHODS: In CheckMate 901 (NCT03036098), a global, open-label, randomized phase 3 trial, pts received NIVO 360 mg plus GC every 3 wk for up to 6 cycles followed by NIVO 480 mg every 4 wk until disease progression/unacceptable toxicity or up to a maximum of 2 years, or GC every 3 wk for up to 6 cycles. Stratification factors were programmed death ligand 1 status and liver metastasis. Primary endpoints were overall survival (OS) and progression-free survival (PFS) by blinded independent central review (BICR). Objective response rate (ORR) per BICR was an exploratory endpoint. Additional exploratory analyses of baseline characteristics, tx exposure, duration of response, and safety in the subgroup of pts who responded to tx are planned. RESULTS: 304 pts were randomized to each tx arm. With a median follow-up of 33.6 mo, both OS (hazard ratio HR, 0.78; 95% confidence interval CI, 0.63–0.96; p=0.0171) and PFS (HR, 0.72; 95% CI, 0.59–0.88; p=0.0012) were significantly improved with NIVO+GC vs GC (Table 1). ORR and complete response (CR) rates were 57.6% and 21.7% with NIVO+GC vs 43.1% and 11.8% with GC. Median duration of CR (95% CI) was 37.1 (18.1–not estimable) mo for NIVO+GC vs 13.2 (7.3–18.4) mo with GC. Grade ≥3 treatment-related adverse events occurred in 61.8% of pts in the NIVO+GC arm and 51.7% of pts in the GC arm. Additional data characterizing pts who responded to tx will be presented. CONCLUSIONS: NIVO+GC demonstrated statistically significant and clinically meaningful improvements in OS and PFS vs GC alone as 1L tx for mUC. No new toxicity signals were observed. NIVO+GC is the first frontline concurrent checkpoint inhibitor+chemo combination to improve OS in this setting. These results support NIVO plus cis-based chemo as a new SOC for pts with mUC. Source of Funding: Bristol Myers Squibb © 2024 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 211Issue 5SMay 2024Page: e723 Advertisement Copyright & Permissions© 2024 by American Urological Association Education and Research, Inc.Metrics Author Information Guru Sonpavde More articles by this author Michiel S. van der Heijden More articles by this author Thomas Powles More articles by this author Andrea Necchi More articles by this author Mauricio Burotto More articles by this author Michael Schenker More articles by this author Juan Pablo Sade More articles by this author Aristotelis Bamias More articles by this author Philippe Beuzeboc More articles by this author Jens Bedke More articles by this author Jan Oldenburg More articles by this author Yüksel Ürün More articles by this author Dingwei Ye More articles by this author Begoña P. Valderrama More articles by this author Yoshihiko Tomita More articles by this author Jeiry Filian More articles by this author Lily Wang More articles by this author Daniela Purcea More articles by this author Federico Nasroulah More articles by this author Matthew D. Galsky More articles by this author Expand All Advertisement PDF downloadLoading ...