2019
Mature results from EV-101: A phase I study of enfortumab vedotin in patients with metastatic urothelial cancer (mUC).
Rosenberg J, Sridhar S, Zhang J, Smith D, Ruether J, Flaig T, Baranda J, Lang J, Plimack E, Sangha R, Heath E, Merchan J, Quinn D, Srinivas S, Milowsky M, Wu C, Gartner E, Melhem-Bertrandt A, Petrylak D. Mature results from EV-101: A phase I study of enfortumab vedotin in patients with metastatic urothelial cancer (mUC). Journal Of Clinical Oncology 2019, 37: 377-377. DOI: 10.1200/jco.2019.37.7_suppl.377.Peer-Reviewed Original ResearchMetastatic urothelial cancerTreatment-related AEsLiver metastasesMedian followUrothelial cancerPrimary tumor siteUnmet medical needMedian PFSPrior chemotherapyMonotherapy studiesMedian durationPoor prognosisCombination therapyPlatinum chemotherapyMature resultsDay 1Nectin-4Medical needTumor siteSecondary objectivePhase IAntitumor activityEncouraging responseSurvival dataChemotherapy
2018
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.
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 endpoint