2020
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.
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 endpointsFORT-1: Phase II/III study of rogaratinib versus chemotherapy (CT) in patients (pts) with locally advanced or metastatic urothelial carcinoma (UC) selected based on FGFR1/3 mRNA expression.
Quinn D, Petrylak D, Bellmunt J, Necchi A, Gurney H, Lee J, Van Der Heijden M, Rosenbaum E, Penel N, Pang S, Li J, Garcia del Muro X, Joly F, Papai Z, Ellinghaus P, Lu C, Nakajima K, Ishida T, Nishiyama H, Sternberg C. FORT-1: Phase II/III study of rogaratinib versus chemotherapy (CT) in patients (pts) with locally advanced or metastatic urothelial carcinoma (UC) selected based on FGFR1/3 mRNA expression. Journal Of Clinical Oncology 2020, 38: 489-489. DOI: 10.1200/jco.2020.38.6_suppl.489.Peer-Reviewed Original ResearchMetastatic urothelial carcinomaUrothelial carcinomaPhase II/III studyMedian progression-free survivalTreatment-emergent adverse eventsMuscle-invasive urothelial carcinomaPhase II/IIIDisease control rateOpen-label studyProgression-free survivalStage IV diseaseAcceptable safety profileUrinary tract infectionDNA alterationsStage IIIBIII studyPrior immunotherapyStandard chemotherapyTract infectionsAdverse eventsMedian agePlatinum chemotherapySafety profileControl rateSubgroup analysis
2018
EV-201 study: A single-arm, open-label, multicenter study of enfortumab vedotin for treatment of patients with locally advanced or metastatic urothelial cancer who previously received immune checkpoint inhibitor therapy.
Rosenberg J, Heath E, O'Donnell P, Hahn N, Balar A, Gartner E, Melhem-Bertrandt A, Petrylak D. EV-201 study: A single-arm, open-label, multicenter study of enfortumab vedotin for treatment of patients with locally advanced or metastatic urothelial cancer who previously received immune checkpoint inhibitor therapy. Journal Of Clinical Oncology 2018, 36: tps542-tps542. DOI: 10.1200/jco.2018.36.6_suppl.tps542.Peer-Reviewed Original ResearchObjective response rateMetastatic urothelial cancerCheckpoint inhibitorsUrothelial cancerMicrotubule-disrupting agent monomethyl auristatin EMulticenter phase 2 studyOngoing phase 1 studiesImmune checkpoint inhibitor therapyAntitumor activityCheckpoint inhibitor therapyDisease control ratePhase 2 doseSafety/tolerabilityTreatment-related AEsImmune checkpoint inhibitorsPhase 2 studyMajority of patientsPhase 1 studyUrinary tract infectionTreatment of patientsTransitional cell carcinomaAssessment of durationMonomethyl auristatin EWarrants further investigationAntibody-drug conjugates
2017
A phase I study of enfortumab vedotin (ASG-22CE; ASG-22ME): Updated analysis of patients with metastatic urothelial cancer.
Petrylak D, Perez R, Zhang J, Smith D, Ruether J, Sridhar S, Sangha R, Lang J, Heath E, Merchan J, Gartner E, Chu R, Anand B, Doñate F, Jackson L, Adams J, Melhem-Bertrandt A, Rosenberg J. A phase I study of enfortumab vedotin (ASG-22CE; ASG-22ME): Updated analysis of patients with metastatic urothelial cancer. Journal Of Clinical Oncology 2017, 35: 106-106. DOI: 10.1200/jco.2017.35.15_suppl.106.Peer-Reviewed Original ResearchTreatment-related adverse eventsMetastatic urothelial cancerOverall response rateNectin-4 expressionUrothelial cancerAntitumor activityMost treatment-related adverse eventsImmune checkpoint inhibitor therapyMedian progression-free survivalPhase IPrior chemotherapy regimenTreatment-related deathsCheckpoint inhibitor therapyMedian treatment durationFavorable tolerability profilePost-baseline assessmentProgression-free survivalUrinary tract infectionAnalysis of patientsMonomethyl auristatin EDifferent dose levelsArchival tumor specimensAntibody-drug conjugatesEvaluable ptsPrior therapy