2023
Study EV-103: Neoadjuvant treatment with enfortumab vedotin monotherapy in cisplatin-ineligible patients (pts) with muscle invasive bladder cancer (MIBC): Updated results for Cohort H.
Flaig T, Rosenberg J, Hoimes C, O'Donnell P, Mar N, Gourdin T, Henry S, Bilen M, George S, Barata P, Srinivas S, Rao S, Assikis V, Burgess E, Ramamurthy C, Haas G, Lukas J, Mildiner-Earley S, Yu Y, Petrylak D. Study EV-103: Neoadjuvant treatment with enfortumab vedotin monotherapy in cisplatin-ineligible patients (pts) with muscle invasive bladder cancer (MIBC): Updated results for Cohort H. Journal Of Clinical Oncology 2023, 41: 4595-4595. DOI: 10.1200/jco.2023.41.16_suppl.4595.Peer-Reviewed Original ResearchMuscle-invasive bladder cancerEvent-free survivalPhase 1b/2 studyPathological complete responseCancer-related therapyEV treatmentUrothelial cancerSafety profilePD-1/L1 inhibitorsMedian event-free survivalPelvic lymph node dissectionAdvanced urothelial cancerAntitumor activityCisplatin-ineligible patientsManageable safety profileNeoadjuvant treatment optionsOngoing phase 2Pathological downstaging ratePts underwent surgeryTolerable safety profileCentral pathology reviewKey secondary endpointLymph node dissectionPhase 3 studyInvasive bladder cancer
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 benefitStudy EV-103 cohort L: Evaluating perioperative enfortumab vedotin monotherapy in cis-ineligible muscle invasive bladder cancer (MIBC) (trial in progress).
Hoimes C, Flaig T, Srinivas S, Mar N, Petrylak D, O'Donnell P, Bilen M, Sasse C, Yu Y, Birrenkott M, Rosenberg J. Study EV-103 cohort L: Evaluating perioperative enfortumab vedotin monotherapy in cis-ineligible muscle invasive bladder cancer (MIBC) (trial in progress). Journal Of Clinical Oncology 2022, 40: tps587-tps587. DOI: 10.1200/jco.2022.40.6_suppl.tps587.Peer-Reviewed Original ResearchMuscle-invasive bladder cancerMetastatic urothelial carcinomaCentral pathology reviewPerioperative therapyPathology reviewMicrotubule-disrupting agent monomethyl auristatin EPathological complete response ratePelvic lymph node dissectionBlinded independent central reviewPathological downstaging rateTolerable safety profileComplete response rateOverall survival benefitDisease-free survivalEvent-free survivalHigh-risk featuresLymph node dissectionPhase 3 studyPD-L1 inhibitorsInvasive bladder cancerIndependent central reviewPlatinum-based therapyMonomethyl auristatin ECurrent standardAntibody-drug conjugates
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