2023
EV-301 long-term outcomes: 24-month findings from the phase III trial of enfortumab vedotin versus chemotherapy in patients with previously treated advanced urothelial carcinoma☆
Rosenberg J, Powles T, Sonpavde G, Loriot Y, Duran I, Lee J, Matsubara N, Vulsteke C, Castellano D, Mamtani R, Wu C, Matsangou M, Campbell M, Petrylak D. EV-301 long-term outcomes: 24-month findings from the phase III trial of enfortumab vedotin versus chemotherapy in patients with previously treated advanced urothelial carcinoma☆. Annals Of Oncology 2023, 34: 1047-1054. PMID: 37678672, DOI: 10.1016/j.annonc.2023.08.016.Peer-Reviewed Original ResearchConceptsProgression-free survivalEnfortumab vedotinAdverse eventsUrothelial carcinomaTreatment-related adverse event ratesMeaningful overall survival benefitPrior platinum-containing chemotherapyWhite blood cell countEvent ratesAdvanced urothelial carcinomaMetastatic urothelial carcinomaOverall survival benefitPeripheral sensory neuropathyPlatinum-containing chemotherapyNew safety signalsPhase III trialsAdverse event ratesRisk of deathBlood cell countIII trialsMaculopapular rashNeutrophil countObjective responseOverall survivalSurvival benefit
2021
Primary results of EV-301: A phase III trial of enfortumab vedotin versus chemotherapy in patients with previously treated locally advanced or metastatic urothelial carcinoma.
Powles T, Rosenberg J, Sonpavde G, Loriot Y, Duran I, Lee J, Matsubara N, Vulsteke C, Wu C, Campbell M, Matsangou M, Petrylak D. Primary results of EV-301: A phase III trial of enfortumab vedotin versus chemotherapy in patients with previously treated locally advanced or metastatic urothelial carcinoma. Journal Of Clinical Oncology 2021, 39: 393-393. DOI: 10.1200/jco.2021.39.6_suppl.393.Peer-Reviewed Original ResearchDisease control rateObjective response rateProgression-free survivalMetastatic urothelial carcinomaPlatinum-containing chemotherapyPhase III studyOverall survivalUrothelial carcinomaChemotherapy groupIII studyInterim analysisInvestigator-assessed progression-free survivalOpen-label phase III studyPD-1/L1 inhibitorsPrior platinum-containing chemotherapyTreatment-related adverse eventsRandomized phase III studyWhite blood cell countMaculo-papular rashPrespecified interim analysisRobust clinical benefitTolerable safety profileMedian overall survivalPhase III trialsRate of grade