2023
Enfortumab vedotin (EV) alone or in combination with pembrolizumab (P) in previously untreated cisplatin-ineligible patients with locally advanced or metastatic urothelial cancer (la/mUC): Subgroup analyses of confirmed objective response rate (cORR) from EV-103 cohort K.
O'Donnell P, Rosenberg J, Hoimes C, Petrylak D, Milowsky M, McKay R, Srinivas S, Friedlander T, Ramamurthy C, Bilen M, Burgess E, Mar N, Moon H, Geynisman D, George S, Carret A, Yu Y, Guseva M, Moreno B, Flaig T. Enfortumab vedotin (EV) alone or in combination with pembrolizumab (P) in previously untreated cisplatin-ineligible patients with locally advanced or metastatic urothelial cancer (la/mUC): Subgroup analyses of confirmed objective response rate (cORR) from EV-103 cohort K. Journal Of Clinical Oncology 2023, 41: 499-499. DOI: 10.1200/jco.2023.41.6_suppl.499.Peer-Reviewed Original ResearchLiver metastasesDay 1Disease sitesPD-L1 expression statusBlinded independent central reviewAppropriate dose modificationCisplatin-ineligible patientsManageable safety profileMetastatic urothelial cancerObjective response rateECOG PS scorePhase 3 trialPre-specified subgroupsPrimary disease siteDuration of responseIndependent central reviewMetastatic disease sitesHigh unmet needECOG PSMedian DoRRECIST v1.1Untreated LAOverall cohortPrimary endpointSecondary endpoints
2021
Study EV-103: Update on durability results and long term outcome of enfortumab vedotin + pembrolizumab in first line locally advanced or metastatic urothelial carcinoma (la/mUC).
Friedlander T, Milowsky M, Bilen M, Srinivas S, McKay R, Flaig T, Hoimes C, Balar A, Henry E, Petrylak D, Sasse C, Kataria R, Yu Y, Carret A, Rosenberg J. Study EV-103: Update on durability results and long term outcome of enfortumab vedotin + pembrolizumab in first line locally advanced or metastatic urothelial carcinoma (la/mUC). Journal Of Clinical Oncology 2021, 39: 4528-4528. DOI: 10.1200/jco.2021.39.15_suppl.4528.Peer-Reviewed Original ResearchMicrotubule-disrupting agent monomethyl auristatin EObjective response rateMetastatic urothelial carcinomaAntibody-drug conjugatesUrothelial carcinomaCommon treatment-related adverse eventsPD-1/PD-L1 inhibitorsConfirmed objective response rateModest objective response rateTreatment-related adverse eventsCarboplatin-based regimensSafety/tolerabilityFirst-line settingOverall survival benefitPeripheral sensory neuropathyNew safety signalsPD-L1 inhibitorsLong-term outcomesImmunogenic cell deathGreater antitumor activityMonomethyl auristatin EBreakthrough therapy designationMedian DoRMedian OSMedian PFS
2020
Study EV-103: Durability results of enfortumab vedotin plus pembrolizumab for locally advanced or metastatic urothelial carcinoma.
Rosenberg J, Flaig T, Friedlander T, Milowsky M, Srinivas S, Petrylak D, Merchan J, Bilen M, Carret A, Yuan N, Sasse C, Hoimes C. Study EV-103: Durability results of enfortumab vedotin plus pembrolizumab for locally advanced or metastatic urothelial carcinoma. Journal Of Clinical Oncology 2020, 38: 5044-5044. DOI: 10.1200/jco.2020.38.15_suppl.5044.Peer-Reviewed Original ResearchMetastatic urothelial carcinomaPD-1/PD-L1 inhibitorsPD-L1 inhibitorsAdverse eventsUrothelial carcinomaDay 1Common treatment-emergent adverse eventsTreatment-emergent adverse eventsCisplatin-ineligible patientsSafety/tolerabilityFirst-line settingManageable safety profilePeripheral sensory neuropathyPlatinum-containing chemotherapyTumor response ratePD-L1 statusMedian DoRMedian OSMedian PFSPFS ratesRECIST v1.1Primary endpointLiver metastasesOS ratesPD-L1Study EV-103: Preliminary durability results of enfortumab vedotin plus pembrolizumab for locally advanced or metastatic urothelial carcinoma.
Rosenberg J, Flaig T, Friedlander T, Milowsky M, Srinivas S, Petrylak D, Merchan J, Bilen M, Carret A, Yuan N, Sasse C, Hoimes C. Study EV-103: Preliminary durability results of enfortumab vedotin plus pembrolizumab for locally advanced or metastatic urothelial carcinoma. Journal Of Clinical Oncology 2020, 38: 441-441. DOI: 10.1200/jco.2020.38.6_suppl.441.Peer-Reviewed Original ResearchMetastatic urothelial carcinomaAdverse eventsUrothelial carcinomaDay 1Common treatment-emergent adverse eventsPD-1/PD-L1 inhibitorsTreatment-emergent adverse eventsSafety/tolerabilityFirst-line settingManageable safety profilePeripheral sensory neuropathyPD-L1 statusPD-L1 inhibitorsMedian DoRMedian PFSRECIST v1.1Primary endpointLiver metastasesStandard therapyPD-L1Sensory neuropathySafety profilePlatinum chemotherapyHigh patientMulticohort study
2019
223TiP EV-301: A phase III trial in progress evaluating enfortumab vedotin versus chemotherapy in patients with locally advanced or metastatic urothelial carcinoma
Petrylak D, Rosenberg J, Lee J, Yonese J, Duran I, Loriot Y, Sonpavde G, Wu C, Gartner E, Melhem-Bertrandt A, Powles T. 223TiP EV-301: A phase III trial in progress evaluating enfortumab vedotin versus chemotherapy in patients with locally advanced or metastatic urothelial carcinoma. Annals Of Oncology 2019, 30: ix75-ix76. DOI: 10.1093/annonc/mdz425.014.Peer-Reviewed Original ResearchMetastatic urothelial carcinomaSeattle GeneticsUrothelial carcinomaDisease progressionCohort 1Microtubule-disrupting agent monomethyl auristatin EDay 1Prior platinum-containing chemotherapyClinical care optionsRadiological disease progressionSafety/tolerabilityTumour response statusPlatinum-containing chemotherapyPhase 2 studyPhase 3 trialPhase III trialsSanofi-AventisPlatinum-based chemotherapyCurrent treatment optionsIndependent central reviewHumanized monoclonal antibodyMonomethyl auristatin ELower survival rateMedian DoRPrimary endpoint
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
2014
808O Inhibition of Pd-L1 By Mpdl3280A Leads to Clinical Activity in Pts with Metastatic Urothelial Bladder Cancer (Ubc)
Bellmunt J, Petrylak D, Powles T, Braiteh F, Vogelzang N, Cruz C, Burris H, Eder J, Fine G, Teng M, Shen X, Bruey J, Boyd Z, Hegde P, Chen D, Loriot Y. 808O Inhibition of Pd-L1 By Mpdl3280A Leads to Clinical Activity in Pts with Metastatic Urothelial Bladder Cancer (Ubc). Annals Of Oncology 2014, 25: iv280. DOI: 10.1093/annonc/mdu337.1.Peer-Reviewed Original ResearchMedian durationPD-L1Metastatic urothelial bladder cancerCaris Life SciencesClinical cutoff dateDrug-related AEsECOG PS 1Employees of GenentechPD-L1 statusPD-L1 expressionPoor prognostic factorReceptor PD-1Urothelial bladder cancerPD-L1 IHCPD-L1 bindingEvaluable ptsIHC 0/1Median DoRPrior chemoPrior cisplatinPrior therapyRECIST v1.1Visceral metastasesLiver metastasesObjective response