2023
Avelumab First-line Maintenance for Advanced Urothelial Carcinoma: Analysis from JAVELIN Bladder 100 by Duration of First-line Chemotherapy and Interval Before Maintenance
Sridhar S, Powles T, Climent Durán M, Park S, Massari F, Thiery-Vuillemin A, Valderrama B, Ullén A, Tsuchiya N, Aragon-Ching J, Gupta S, Petrylak D, Bellmunt J, Wang J, Laliberte R, di Pietro A, Costa N, Grivas P, Sternberg C, Loriot Y. Avelumab First-line Maintenance for Advanced Urothelial Carcinoma: Analysis from JAVELIN Bladder 100 by Duration of First-line Chemotherapy and Interval Before Maintenance. European Urology 2023, 85: 154-163. PMID: 37714742, DOI: 10.1016/j.eururo.2023.08.001.Peer-Reviewed Original ResearchBest supportive careProgression-free survivalAdvanced urothelial carcinomaFirst-line chemotherapyPlatinum-based chemotherapyOverall survivalFirst-line maintenanceChemotherapy durationMaintenance treatmentUrothelial carcinomaFirst-line platinum-based chemotherapyAnalysis of OSAdvanced urothelial cancerPhase 3 trialAnalysis of subgroupsAdvanced UCPrior chemotherapyProspective trialSafety findingsSupportive careHazard ratioUrothelial cancerDisease progressionChemotherapyOverall populationAvelumab First-line Maintenance Therapy for Advanced Urothelial Carcinoma: Comprehensive Clinical Subgroup Analyses from the JAVELIN Bladder 100 Phase 3 Trial
Grivas P, Park S, Voog E, Caserta C, Gurney H, Bellmunt J, Kalofonos H, Ullén A, Loriot Y, Sridhar S, Yamamoto Y, Petrylak D, Sternberg C, Gupta S, Huang B, Costa N, Laliberte R, di Pietro A, Valderrama B, Powles T. Avelumab First-line Maintenance Therapy for Advanced Urothelial Carcinoma: Comprehensive Clinical Subgroup Analyses from the JAVELIN Bladder 100 Phase 3 Trial. European Urology 2023, 84: 95-108. PMID: 37121850, DOI: 10.1016/j.eururo.2023.03.030.Peer-Reviewed Original ResearchConceptsBest supportive careProgression-free survivalAdvanced urothelial carcinomaPlatinum-based chemotherapyOverall survivalHazard ratioUrothelial carcinomaAnalysis of OSFirst-line maintenance therapyRelevant subgroupsCox proportional hazards modelClinical subgroup analysisPhase 3 trialKaplan-Meier methodProportional hazards modelFirst-line maintenanceMetastatic UCMaintenance therapyStable diseaseSupportive careComplete responsePartial responseAdvanced cancerPD-L1Maintenance treatment
2022
Avelumab first-line (1L) maintenance for advanced urothelial carcinoma (UC): Long-term follow-up results from the JAVELIN Bladder 100 trial.
Powles T, Park H, Voog E, Caserta C, Pérez-Valderrama B, Gurney H, Loriot Y, Sridhar S, Tsuchiya N, Sternberg C, Bellmunt J, Aragon-Ching J, Petrylak D, Blake-Haskins A, Laliberte R, Wang J, Costa N, Grivas P. Avelumab first-line (1L) maintenance for advanced urothelial carcinoma (UC): Long-term follow-up results from the JAVELIN Bladder 100 trial. Journal Of Clinical Oncology 2022, 40: 487-487. DOI: 10.1200/jco.2022.40.6_suppl.487.Peer-Reviewed Original ResearchBest supportive careAdvanced urothelial carcinomaProgression-free survivalPlatinum-containing chemotherapyUrothelial carcinomaOverall survivalPD-L1Metastatic urothelial carcinomaNew safety signalsLonger overall survivalLong-term followStandard of careLong-term safetyFirst-line maintenanceAnticancer drug therapyOS benefitProlonged OSMonotherapy studiesPrimary endpointSecondary endpointsAlone armPrespecified subgroupsSupportive careTreatment guidelinesDrug therapy
2021
Avelumab first-line (1L) maintenance for advanced urothelial carcinoma (UC): Analysis of clinical and genomic subgroups from the JAVELIN Bladder 100 trial.
Powles T, Petrylak D, Park H, Sridhar S, Caserta C, Vuillemin A, Lee H, Bellmunt J, Yamamoto Y, Aragon-Ching J, Huang B, Ching K, Davis C, Di Pietro A, Loriot Y, Grivas P. Avelumab first-line (1L) maintenance for advanced urothelial carcinoma (UC): Analysis of clinical and genomic subgroups from the JAVELIN Bladder 100 trial. Journal Of Clinical Oncology 2021, 39: 4520-4520. DOI: 10.1200/jco.2021.39.15_suppl.4520.Peer-Reviewed Original ResearchBest supportive careAdvanced urothelial carcinomaOverall survivalUrothelial carcinomaPD-L1OS benefitGenomic subtypesMetastatic urothelial carcinomaPlatinum-containing chemotherapyPlatinum-based chemotherapyProlonged overall survivalStandard of careFirst-line maintenanceGenomic subgroupsSubgroups of interestBSC armEligible ptsUnresectable diseasePrimary endpointSupportive careCancer Genome AtlasLymph nodesTract tumorsDisease stageTCGA subtypesAvelumab (Ave) first-line (1L) maintenance plus best supportive care (BSC) versus BSC alone for advanced urothelial carcinoma (UC): JAVELIN Bladder 100 subgroup analysis based on duration and cycles of 1L chemotherapy.
Loriot Y, Powles T, Climent Durán M, Sridhar S, Bellmunt J, Petrylak D, Wang J, Costa N, Laliberte R, Di Pietro A, Grivas P, Sternberg C. Avelumab (Ave) first-line (1L) maintenance plus best supportive care (BSC) versus BSC alone for advanced urothelial carcinoma (UC): JAVELIN Bladder 100 subgroup analysis based on duration and cycles of 1L chemotherapy. Journal Of Clinical Oncology 2021, 39: 438-438. DOI: 10.1200/jco.2021.39.6_suppl.438.Peer-Reviewed Original ResearchBest supportive careAdvanced urothelial carcinomaOverall survivalUrothelial carcinomaOS benefitUnstratified Cox proportional hazards modelProgression-free survival benefitCox proportional hazards modelMetastatic urothelial carcinomaPlatinum-containing chemotherapyDuration of chemotherapyNumber of patientsAnalysis of efficacyProportional hazards modelFirst-line maintenanceDelay/interruptionChemotherapy subgroupEligible patientsBaseline characteristicsDose intensityInvestigator's discretionSupportive careSurvival benefitTreatment armsTreatment patterns
2020
Avelumab first-line (1L) maintenance + best supportive care (BSC) vs BSC alone for advanced urothelial carcinoma (UC): Association between clinical outcomes and exploratory biomarkers
Powles T, Loriot Y, Bellmunt J, Sternberg C, Sridhar S, Petrylak D, Tambaro R, Dourthe L, Alvarez-Fernandez C, Aarts M, Mu X, Ching K, Pu J, Roychoudhury S, Davis C, di Pietro A, Grivas P. Avelumab first-line (1L) maintenance + best supportive care (BSC) vs BSC alone for advanced urothelial carcinoma (UC): Association between clinical outcomes and exploratory biomarkers. Annals Of Oncology 2020, 31: s552-s553. DOI: 10.1016/j.annonc.2020.08.771.Peer-Reviewed Original ResearchMaintenance avelumab + best supportive care (BSC) versus BSC alone after platinum-based first-line (1L) chemotherapy in advanced urothelial carcinoma (UC): JAVELIN Bladder 100 phase III interim analysis.
Powles T, Park S, Voog E, Caserta C, Valderrama B, Gurney H, Kalofonos H, Radulovic S, Demey W, Ullén A, Loriot Y, Sridhar S, Tsuchiya N, Kopyltsov E, Sternberg C, Bellmunt J, Aragon-Ching J, Petrylak D, di Pietro A, Grivas P. Maintenance avelumab + best supportive care (BSC) versus BSC alone after platinum-based first-line (1L) chemotherapy in advanced urothelial carcinoma (UC): JAVELIN Bladder 100 phase III interim analysis. Journal Of Clinical Oncology 2020, 38: lba1-lba1. DOI: 10.1200/jco.2020.38.18_suppl.lba1.Peer-Reviewed Original ResearchBest supportive careAdvanced urothelial carcinomaProgression-free survivalMedian overall survivalOverall survivalPlatinum-based chemotherapyPD-L1Urothelial carcinomaAdverse eventsSupportive carePlatinum-based first-line chemotherapyCausality adverse eventsCycles of gemcitabineFirst-line chemotherapyMetastatic urothelial carcinomaPhase 3 trialUrinary tract infectionIndependent central reviewEligible patientsNonvisceral diseaseOS benefitStable diseaseMaintenance therapyPrimary endpointSecondary endpoints
2016
842TiP A multicentre, international, randomised, open-label phase 3 trial of avelumab + best supportive care (BSC) vs BSC alone as maintenance therapy after first-line platinum-based chemotherapy in patients with advanced urothelial cancer (JAVELIN bladder 100)
Powles T, Grivas P, Aragon-Ching J, Faroun Y, Kessler E, Tomita Y, Chakrabarti D, Laliberte R, Shnaidman M, Petrylak D. 842TiP A multicentre, international, randomised, open-label phase 3 trial of avelumab + best supportive care (BSC) vs BSC alone as maintenance therapy after first-line platinum-based chemotherapy in patients with advanced urothelial cancer (JAVELIN bladder 100). Annals Of Oncology 2016, 27: vi292. DOI: 10.1093/annonc/mdw373.69.Peer-Reviewed Original Research