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: New randomized cohort testing enfortumab vedotin as monotherapy or in combination with pembrolizumab in locally advanced or metastatic urothelial cancer.
Mar N, Friedlander T, Hoimes C, Flaig T, Bilen M, Balar A, Henry E, Srinivas S, Rosenberg J, Petrylak D, Burgess E, Merchan J, Tagawa S, Carret A, Steinberg J, Chaney M, Milowsky M. Study EV-103: New randomized cohort testing enfortumab vedotin as monotherapy or in combination with pembrolizumab in locally advanced or metastatic urothelial cancer. Journal Of Clinical Oncology 2020, 38: tps5092-tps5092. DOI: 10.1200/jco.2020.38.15_suppl.tps5092.Peer-Reviewed Original ResearchPD-1/PD-L1 inhibitorsPlatinum-containing chemotherapyMetastatic urothelial cancerPD-L1 inhibitorsRECIST v1.1Investigator assessmentUrothelial cancerMicrotubule-disrupting agent monomethyl auristatin EDay 1PD-1 inhibitor pembrolizumabActive CNS metastasesCisplatin-containing therapyFirst-line patientsPrior systemic treatmentPD-L1 statusTumor response rateMonomethyl auristatin EAntibody-drug conjugatesMeasurable diseaseCNS metastasisPrimary endpointSecondary endpointsCreatinine clearanceSystemic treatmentUncontrolled diabetesStudy 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
929P Biomarker analyses of ramucirumab in patients with platinum refractory urothelial cancer from RANGE, a global, randomized, double-blind, phase III study
van der Heijden M, Powles T, Petrylak D, de Wit R, Chi K, Necchi A, Sternberg C, Matsubara N, Nishiyama H, Castellano D, Hussain S, Bamias A, Hozak R, Rhodes R, Xia M, Rasmussen E, Aggarwal A, Wijayawardana S, Bell-McGuinn K, Drakaki A. 929P Biomarker analyses of ramucirumab in patients with platinum refractory urothelial cancer from RANGE, a global, randomized, double-blind, phase III study. Annals Of Oncology 2019, 30: v373-v374. DOI: 10.1093/annonc/mdz249.028.Peer-Reviewed Original ResearchCombined positive scorePD-L1 statusPersonal feesHazard ratioBasal subtypeMolecular subtypesEli LillyPD-L1 combined positive scorePlatinum-refractory urothelial carcinomaPositive PD-L1 statusTumor cellsSeattle GeneticsExploratory biomarker analysisImmune cell stainingPD-L1 groupRefractory urothelial cancerImproved overall survivalPD-L1 antibodiesPD-L1 immunohistochemistryClaudin-low subtypeRefractory urothelial carcinomaUrothelial carcinoma molecular subtypesArchival tumor tissueBiomarker analysisMedian OSLong-term outcomes in elderly patients (pts) from IMvigor210: Atezolizumab (atezo) in metastatic urothelial cancer (mUC).
Balar A, Dreicer R, Loriot Y, Perez-Gracia J, Hoffman-Censits J, Petrylak D, Van Der Heijden M, Shen X, Ding B, Ramirez-Montagut T, Rosenberg J. Long-term outcomes in elderly patients (pts) from IMvigor210: Atezolizumab (atezo) in metastatic urothelial cancer (mUC). Journal Of Clinical Oncology 2019, 37: 394-394. DOI: 10.1200/jco.2019.37.7_suppl.394.Peer-Reviewed Original ResearchMetastatic urothelial cancerElderly ptsCR ratePD-L1 statusSingle-arm studyLong-term outcomesLong-term efficacyEvaluable ptsMedian OSEfficacy outcomesElderly patientsClinical outcomesUrothelial cancerClinical benefitPoor outcomeSubgroup analysisOverall populationChemotherapyOutcomesCisplatinAtezoAtezolizumabQ3wOSPatients
2016
IMvigor 210, a phase II trial of atezolizumab (MPDL3280A) in platinum-treated locally advanced or metastatic urothelial carcinoma (mUC).
Hoffman-Censits J, Grivas P, Van Der Heijden M, Dreicer R, Loriot Y, Retz M, Vogelzang N, Perez-Gracia J, Rezazadeh A, Bracarda S, Yu E, Hoimes C, Bellmunt J, Quinn D, Petrylak D, Hussain S, Cui N, Mariathasan S, Abidoye O, Rosenberg J. IMvigor 210, a phase II trial of atezolizumab (MPDL3280A) in platinum-treated locally advanced or metastatic urothelial carcinoma (mUC). Journal Of Clinical Oncology 2016, 34: 355-355. DOI: 10.1200/jco.2016.34.2_suppl.355.Peer-Reviewed Original ResearchMetastatic urothelial carcinomaPoor prognostic factorPrognostic factorsPD-L1Prognostic subgroupsPD-L1/PDImmune cell statusMedian treatment durationPD-L1 subgroupsTreatment-related AEsPD-L1 expressionPD-L1 statusPhase II trialPlatinum-based chemotherapyCo-primary endpointsPoor prognostic subgroupMUC patientsRECIST v1.1Data cutoffDurable responsesII trialAntitumor immunityG3-4Median ageHistoric controls
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