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 conjugatesEnfortumab vedotin (EV) in patients (Pts) with metastatic urothelial carcinoma (mUC) with prior checkpoint inhibitor (CPI) failure: A prospective cohort of an ongoing phase 1 study.
Petrylak D, Smith D, Flaig T, Zhang J, Sridhar S, Ruether J, Plimack E, Merchan J, Quinn D, Kilari D, Srinivas S, Baranda J, Lang J, Milowsky M, Galsky M, Spira A, Gartner E, Wu C, Melhem-Bertrandt A, Rosenberg J. Enfortumab vedotin (EV) in patients (Pts) with metastatic urothelial carcinoma (mUC) with prior checkpoint inhibitor (CPI) failure: A prospective cohort of an ongoing phase 1 study. Journal Of Clinical Oncology 2018, 36: 431-431. DOI: 10.1200/jco.2018.36.6_suppl.431.Peer-Reviewed Original ResearchMetastatic urothelial carcinomaOngoing phase 1 studiesPhase 1 studyLiver metastasesEvaluable ptsDisease progressionNectin-4High unmet medical needPhase 2 dosePost-baseline scanAntitumor activityMedian treatment durationPhase 2 studyPrimary tumor siteHigh unmet needUnmet medical needMonomethyl auristatin E.CPI therapyFatal AEsPrior chemotherapyPrior therapyRECIST v1.1Unconfirmed PRMetastatic settingPrimary endpointEV-103 study: A phase 1b dose-escalation and dose-expansion study of enfortumab vedotin in combination with immune checkpoint inhibitor (CPI) therapy for treatment of patients with locally advanced or metastatic urothelial cancer.
Hoimes C, Petrylak D, Flaig T, Carret A, Melhem-Bertrandt A, Rosenberg J. EV-103 study: A phase 1b dose-escalation and dose-expansion study of enfortumab vedotin in combination with immune checkpoint inhibitor (CPI) therapy for treatment of patients with locally advanced or metastatic urothelial cancer. Journal Of Clinical Oncology 2018, 36: tps532-tps532. DOI: 10.1200/jco.2018.36.6_suppl.tps532.Peer-Reviewed Original ResearchObjective response rateMicrotubule-disrupting agent monomethyl auristatin ECheckpoint inhibitorsMetastatic urothelial cancerAntibody-drug conjugatesUrothelial cancerFirst-line cisplatin-based chemotherapyResponse rateOngoing phase 1 studiesImmune checkpoint inhibitor therapyCheckpoint inhibitor therapyDisease control rateDose-expansion studyFirst-line cisplatinPhase 1b studyPlatinum-containing regimenImmune checkpoint inhibitorsCisplatin-based chemotherapyPhase 1 studyTumor immune infiltrationDuration of responseMMAE antibody–drug conjugatesTreatment of patientsTransitional cell carcinomaPhase 1 study results