2022
Long-term outcomes in EV-301: 24-month findings from the phase 3 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. Long-term outcomes in EV-301: 24-month findings from the phase 3 trial of enfortumab vedotin versus chemotherapy in patients with previously treated advanced urothelial carcinoma. Journal Of Clinical Oncology 2022, 40: 4516-4516. DOI: 10.1200/jco.2022.40.16_suppl.4516.Peer-Reviewed Original ResearchProgression-free survivalOverall survivalStandard chemotherapyUrothelial carcinomaInterim analysisInvestigator-assessed progression-free survivalLong-term clinical profilesPrior platinum-containing chemotherapyTreatment-related adverse eventsPrespecified interim analysisRobust clinical benefitTolerable safety profileAdvanced urothelial carcinomaMedian overall survivalMetastatic urothelial carcinomaPlatinum-containing chemotherapyNew safety signalsPhase 3 trialRate of gradeLonger overall survivalLong-term outcomesStandard of careAntibody-drug conjugatesConsistent survival advantageOS 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