2020
Study EV-103: New cohorts testing enfortumab vedotin alone or in combination with pembrolizumab in muscle invasive urothelial cancer.
Hoimes C, Rosenberg J, Petrylak D, Carret A, Sasse C, Chaney M, Flaig T. Study EV-103: New cohorts testing enfortumab vedotin alone or in combination with pembrolizumab in muscle invasive urothelial cancer. Journal Of Clinical Oncology 2020, 38: tps595-tps595. DOI: 10.1200/jco.2020.38.6_suppl.tps595.Peer-Reviewed Original ResearchMuscle-invasive urothelial cancerInvasive urothelial cancerRadical cystectomyPathology reviewUrothelial cancerMicrotubule-disrupting agent monomethyl auristatin EDay 1PD-1/PD-L1 inhibitorsResponse rateInvestigational antibody-drug conjugatePathological complete response rateTreatment-related adverse eventsNeoadjuvant cisplatin-based chemotherapyCisplatin-eligible patientsPathological response rateComplete response rateFirst-line settingLymph node dissectionPD-1 inhibitorsCentral pathology reviewDisease-free survivalPhase 2 studyCisplatin-based chemotherapyPD-L1 inhibitorsMonomethyl auristatin E
2019
Treatment of locally advanced or metastatic urothelial carcinoma: Analysis of expert and community healthcare provider practice trends.
Rosenthal K, Galsky M, Milowsky M, Petrylak D, Rosenberg J, Obholz K, Plimack E. Treatment of locally advanced or metastatic urothelial carcinoma: Analysis of expert and community healthcare provider practice trends. Journal Of Clinical Oncology 2019, 37: 389-389. DOI: 10.1200/jco.2019.37.7_suppl.389.Peer-Reviewed Original ResearchImmune checkpoint inhibitorsCisplatin-based chemotherapyMetastatic urothelial carcinomaUrothelial carcinomaHealthcare providersExact testDifferent immune checkpoint inhibitorsPD-L1 testingFischer's exact testFDA label changePearson chi-squaredEligible ptsCheckpoint inhibitorsEligible casesTreatment indicationsTreatment decisionsClinical practicePractice trendsNew indicationsExpert recommendationsChi-squaredCarcinomaLabel changesEV-301: Phase III study to evaluate enfortumab vedotin (EV) versus chemotherapy in patients with previously treated locally advanced or metastatic urothelial cancer (la/mUC).
Petrylak D, Rosenberg J, Duran I, Loriot Y, Sonpavde G, Wu C, Gartner E, Melhem-Bertrandt A, Powles T. EV-301: Phase III study to evaluate enfortumab vedotin (EV) versus chemotherapy in patients with previously treated locally advanced or metastatic urothelial cancer (la/mUC). Journal Of Clinical Oncology 2019, 37: tps497-tps497. DOI: 10.1200/jco.2019.37.7_suppl.tps497.Peer-Reviewed Original ResearchObjective response rateCheckpoint inhibitorsEnfortumab vedotinDisease progressionMicrotubule-disrupting agent monomethyl auristatin EDay 1Open-label phase 3 trialResponse rateECOG performance status scorePivotal phase 2 studyPrior platinum-containing chemotherapyStandard first-line treatmentCarboplatin-based chemotherapyImmune checkpoint inhibitorsMetastatic urothelial cancerPerformance status scorePlatinum-containing chemotherapyRadiological disease progressionSafety/tolerabilityTumour response statusPhase 2 studyPhase 3 trialPhase III studyProgression-free survivalCisplatin-based chemotherapy
2018
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.
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