2021
Enfortumab vedotin in cisplatin-ineligible patients with locally advanced or metastatic urothelial cancer who received prior PD-1/PD-L1 inhibitors: An updated analysis of EV-201 Cohort 2.
McGregor B, Balar A, Rosenberg J, Van Der Heijden M, Park H, Lee J, Kojima T, Harrison M, Heath E, Stein M, Loriot Y, Necchi A, Steinberg J, Liang S, Trowbridge J, Petrylak D, Yu E. Enfortumab vedotin in cisplatin-ineligible patients with locally advanced or metastatic urothelial cancer who received prior PD-1/PD-L1 inhibitors: An updated analysis of EV-201 Cohort 2. Journal Of Clinical Oncology 2021, 39: 4524-4524. DOI: 10.1200/jco.2021.39.15_suppl.4524.Peer-Reviewed Original ResearchBlinded independent central reviewObjective response rateProgression-free survivalDuration of responseComplete responsePD-1/PD-L1 inhibitorsPrimary analysisConfirmed objective response rateCisplatin-ineligible patientsMetastatic urothelial cancerMetastatic urothelial carcinomaOverall survival benefitPeripheral sensory neuropathyPlatinum-containing chemotherapyNew safety signalsPD-L1 inhibitorsIndependent central reviewPrimary tumor siteOnset of responseAntibody-drug conjugatesPrior platinumPrimary endpointRECIST 1.1Secondary endpointsAdverse eventsEV-201 Cohort 2: Enfortumab vedotin in cisplatin-ineligible patients with locally advanced or metastatic urothelial cancer who received prior PD-1/PD-L1 inhibitors.
Balar A, McGregor B, Rosenberg J, Van Der Heijden M, Park S, Lee J, Harrison M, Heath E, Stein M, Loriot Y, Necchi A, Steinberg J, Liang S, Kim E, Trowbridge J, Campbell M, Petrylak D, Yu E. EV-201 Cohort 2: Enfortumab vedotin in cisplatin-ineligible patients with locally advanced or metastatic urothelial cancer who received prior PD-1/PD-L1 inhibitors. Journal Of Clinical Oncology 2021, 39: 394-394. DOI: 10.1200/jco.2021.39.6_suppl.394.Peer-Reviewed Original ResearchPD-1/L1Blinded independent central reviewObjective response rateProgression-free survivalDuration of responseOverall survivalPD-1/L1 inhibitorsPD-1/PD-L1 inhibitorsConfirmed objective response rateCisplatin-ineligible patientsECOG PS 2Metastatic urothelial cancerMetastatic urothelial carcinomaPeripheral sensory neuropathyPlatinum-containing chemotherapySevere renal impairmentPD-L1 inhibitorsIndependent central reviewPrimary tumor siteCohort 1 dataAntibody-drug conjugatesAdult ptsPrior platinumRECIST 1.1Last dose
2019
EV-201: Results of enfortumab vedotin monotherapy for locally advanced or metastatic urothelial cancer previously treated with platinum and immune checkpoint inhibitors.
Petrylak D, Balar A, O'Donnell P, McGregor B, Heath E, Yu E, Galsky M, Hahn N, Gartner E, Pinelli J, Melhem-Bertrandt A, Rosenberg J. EV-201: Results of enfortumab vedotin monotherapy for locally advanced or metastatic urothelial cancer previously treated with platinum and immune checkpoint inhibitors. Journal Of Clinical Oncology 2019, 37: 4505-4505. DOI: 10.1200/jco.2019.37.18_suppl.lba4505.Peer-Reviewed Original ResearchTreatment-related AEsMetastatic urothelial cancerCheckpoint inhibitorsDuration of responseLiver metastasesUrothelial cancerCohort 1Common treatment-related AEsBlinded independent central reviewImmune checkpoint inhibitorsManageable safety profilePlatinum-containing chemotherapyPhase 1 trialLimited treatment optionsIndependent central reviewHigh unmet needTwo-cohort studyMUC patientsPrior chemotherapyPrior platinumRECIST 1.1Primary endpointSecondary endpointsPulmonary infectionPeripheral neuropathy
2015
Clinical activity, safety, and biomarkers of MPDL3280A in metastatic urothelial bladder cancer: Additional analysis from phase IA study.
Kim J, Bellmunt J, Powles T, Loriot Y, Vogelzang N, Cruz Zambrano C, Burris H, Teng S, Shen X, Bruey J, Boyd Z, Hegde P, Petrylak D. Clinical activity, safety, and biomarkers of MPDL3280A in metastatic urothelial bladder cancer: Additional analysis from phase IA study. Journal Of Clinical Oncology 2015, 33: 297-297. DOI: 10.1200/jco.2015.33.7_suppl.297.Peer-Reviewed Original ResearchUrothelial bladder cancerMetastatic urothelial bladder cancerPD-L1 expressionBladder cancerImmune-mediated antitumor responsePD-L1/PDPhase Ia studyTreatment-related AEsTreatment-related deathsTumor burden markersTumor gene expressionIHC 0/1Median DoRPrior platinumPt ageRECIST v1.1Median PFSPrior therapyData cutoffDurable responsesExpansion cohortInflammatory markersLiver metastasesPD-L1Antitumor response