2024
1968P Study EV-103 dose escalation/cohort A (DE/A): 5y follow-up of first-line (1L) enfortumab vedotin (EV) + pembrolizumab (P) in cisplatin (CIS)-ineligible locally advanced or metastatic urothelial carcinoma (la/mUC)
Rosenberg J, Petrylak D, Flaig T, Hoimes C, Gupta S, O'Donnell P, Mar N, Friedlander T, Tagawa S, Bilen M, Brown J, McKay R, Merchan J, Srinivas S, Shetty A, Moreno B, Davis G, Wirtz H, Zhu Y, Milowsky M. 1968P Study EV-103 dose escalation/cohort A (DE/A): 5y follow-up of first-line (1L) enfortumab vedotin (EV) + pembrolizumab (P) in cisplatin (CIS)-ineligible locally advanced or metastatic urothelial carcinoma (la/mUC). Annals Of Oncology 2024, 35: s1139-s1140. DOI: 10.1016/j.annonc.2024.08.2053.Peer-Reviewed Original ResearchA phase III randomized trial of eribulin (E) with gemcitabine (G) vs standard of care (SOC) for patients (pts) with metastatic urothelial carcinoma (mUC) refractory to or ineligible for PD/PDL1 antibody (Ab): SWOG S1937 updated design.
Sadeghi S, Plets M, Lara P, Tangen C, Berg S, Brown J, Bangs R, Nakagawa D, Daneshmand S, Ian M. Jr., Flaig T, Petrylak D, Lerner S. A phase III randomized trial of eribulin (E) with gemcitabine (G) vs standard of care (SOC) for patients (pts) with metastatic urothelial carcinoma (mUC) refractory to or ineligible for PD/PDL1 antibody (Ab): SWOG S1937 updated design. Journal Of Clinical Oncology 2024, 42: tps4617-tps4617. DOI: 10.1200/jco.2024.42.16_suppl.tps4617.Peer-Reviewed Original ResearchProgression free survivalMetastatic urothelial carcinomaMedian progression free survivalStandard of careOverall survivalEnfortumab vedotinSacituzumab govitecanFree survivalCisplatin-ineligible metastatic urothelial carcinomaPhase III randomized trialMedian overall survivalStudies of eribulinEndpoint of OSFGFR alterationsLiver metastasesSystemic therapyEligible ptsUrothelial carcinomaPrimary endpointGenitourinary cancersTreatment changesEribulinResponse rateActivity of EORRTROPHY-U-01, a phase II open-label study of sacituzumab govitecan in patients with metastatic urothelial carcinoma progressing after platinum-based chemotherapy and checkpoint inhibitors: updated safety and efficacy outcomes
Loriot Y, Petrylak D, Kalebasty A, Fléchon A, Jain R, Gupta S, Bupathi M, Beuzeboc P, Palmbos P, Balar A, Kyriakopoulos C, Pouessel D, Sternberg C, Tonelli J, Sierecki M, Zhou H, Grivas P, Barthélémy P, Tagawa S. TROPHY-U-01, a phase II open-label study of sacituzumab govitecan in patients with metastatic urothelial carcinoma progressing after platinum-based chemotherapy and checkpoint inhibitors: updated safety and efficacy outcomes. Annals Of Oncology 2024, 35: 392-401. PMID: 38244927, DOI: 10.1016/j.annonc.2024.01.002.Peer-Reviewed Original ResearchAssociated with increased adverse eventsMetastatic urothelial carcinomaProgression-free survivalPlatinum-based chemotherapySacituzumab govitecanUGT1A1 statusFollow-upCohort 1Checkpoint inhibitorsOverall survivalUrothelial carcinomaAccelerated US Food and Drug Administration approvalPhase II open-label studyTreated with platinum-based chemotherapyMedian progression-free survivalUS Food and Drug Administration approvalActive metabolite of irinotecanFood and Drug Administration approvalIrinotecan-based therapyTreatment-related discontinuationsUridine diphosphate glucuronosyltransferase 1A1Metabolite of irinotecanInhibitor-based therapyDrug Administration approvalAntibody-drug conjugatesEfficacy of Antibody Drug Conjugates Alone and in Combination with other Agents in Metastatic Urothelial Carcinoma: A Scoping Review
Grant M, Stockhammer P, Austin M, Nemeth Z, Petrylak D. Efficacy of Antibody Drug Conjugates Alone and in Combination with other Agents in Metastatic Urothelial Carcinoma: A Scoping Review. Bladder Cancer 2024, 10: 9-23. PMID: 38993528, PMCID: PMC11181835, DOI: 10.3233/blc-230070.Peer-Reviewed Original ResearchMetastatic urothelial carcinomaAntibody-drug conjugatesClinical trialsUrothelial carcinomaCombination regimensDrug conjugatesSystematic reviewAnti-PD-1 agentsProspective therapeutic clinical trialsCochrane Central TrialsClinical trial cohortObjective response rateTherapeutic clinical trialsMeta-Analyses (PRISMA) statementNon-duplicated articlesPreferred Reporting ItemsComprehensive systematic reviewPotent cytotoxic payloadTrial cohortEnfortumab vedotinOvid EmbaseSacituzumab govitecanADC targetImpressive efficacyOvid MEDLINE
2023
Phase I Dose-Escalation Study of the Safety and Pharmacokinetics of AGS15E Monotherapy in Patients with Metastatic Urothelial Carcinoma
Petrylak D, Eigl B, George S, Heath E, Hotte S, Chism D, Nabell L, Picus J, Cheng S, Appleman L, Sonpavde G, Morgans A, Pourhosseini P, Wu R, Standley L, Croitoru R, Yu E. Phase I Dose-Escalation Study of the Safety and Pharmacokinetics of AGS15E Monotherapy in Patients with Metastatic Urothelial Carcinoma. Clinical Cancer Research 2023, 30: of1-of11. PMID: 37861407, PMCID: PMC10767306, DOI: 10.1158/1078-0432.ccr-22-3627.Peer-Reviewed Original ResearchConceptsMetastatic urothelial carcinomaObjective response rateDose-limiting toxicityAntibody-drug conjugatesUrothelial carcinomaCommon treatment-emergent adverse eventsInvestigational antibody-drug conjugateTreatment-emergent adverse eventsI dose-escalation studyDose-expansion cohortsCheckpoint inhibitor therapyPhase II doseDose-escalation studyDose-proportional mannerMultiple-dose administrationBest overall responseMonomethyl auristatin ECytotoxic drug monomethyl auristatin EPrior chemotherapyAdverse eventsDose escalationInhibitor therapyPeripheral neuropathyOcular toxicityExpansion trialEV-301 long-term outcomes: 24-month findings from the phase III trial of enfortumab vedotin versus chemotherapy in patients with previously treated advanced urothelial carcinoma☆
Rosenberg J, Powles T, Sonpavde G, Loriot Y, Duran I, Lee J, Matsubara N, Vulsteke C, Castellano D, Mamtani R, Wu C, Matsangou M, Campbell M, Petrylak D. EV-301 long-term outcomes: 24-month findings from the phase III trial of enfortumab vedotin versus chemotherapy in patients with previously treated advanced urothelial carcinoma☆. Annals Of Oncology 2023, 34: 1047-1054. PMID: 37678672, DOI: 10.1016/j.annonc.2023.08.016.Peer-Reviewed Original ResearchConceptsProgression-free survivalEnfortumab vedotinAdverse eventsUrothelial carcinomaTreatment-related adverse event ratesMeaningful overall survival benefitPrior platinum-containing chemotherapyWhite blood cell countEvent ratesAdvanced urothelial carcinomaMetastatic urothelial carcinomaOverall survival benefitPeripheral sensory neuropathyPlatinum-containing chemotherapyNew safety signalsPhase III trialsAdverse event ratesRisk of deathBlood cell countIII trialsMaculopapular rashNeutrophil countObjective responseOverall survivalSurvival benefitA phase III randomized trial of eribulin (E) with or without gemcitabine vs standard of care (SOC) for metastatic urothelial carcinoma (UC) refractory to or ineligible for PD/PDL1 antibody (Ab): SWOG S1937.
Sadeghi S, Plets M, Lara P, Tangen C, Bangs R, Lerner S, Flaig T, Petrylak D, Thompson I. A phase III randomized trial of eribulin (E) with or without gemcitabine vs standard of care (SOC) for metastatic urothelial carcinoma (UC) refractory to or ineligible for PD/PDL1 antibody (Ab): SWOG S1937. Journal Of Clinical Oncology 2023, 41: tps4608-tps4608. DOI: 10.1200/jco.2023.41.16_suppl.tps4608.Peer-Reviewed Original ResearchStandard of careMedian overall survivalObjective response rateProgression-free survivalMedian progression-free survivalMetastatic urothelial carcinomaOverall survivalUrothelial carcinomaMetastatic UCPlatinum-based first-line chemotherapyCurrent SOCCisplatin-ineligible patientsCommon genitourinary cancerCommon grade 3Non-platinum regimenFirst-line chemotherapyPhase IIIStandard dosingIneligible patientsLine chemotherapyMedian OSPrior regimensFree survivalFGFR alterationsGenitourinary cancersStudy EV-103 dose escalation/cohort A: Long-term outcome of enfortumab vedotin + pembrolizumab in first-line (1L) cisplatin-ineligible locally advanced or metastatic urothelial carcinoma (la/mUC) with nearly 4 years of follow-up.
Gupta S, Rosenberg J, McKay R, Flaig T, Petrylak D, Hoimes C, Friedlander T, Bilen M, Srinivas S, Burgess E, Merchan J, Tagawa S, Brown J, Yu Y, Carret A, Wirtz H, Guseva M, Homet Moreno B, Milowsky M. Study EV-103 dose escalation/cohort A: Long-term outcome of enfortumab vedotin + pembrolizumab in first-line (1L) cisplatin-ineligible locally advanced or metastatic urothelial carcinoma (la/mUC) with nearly 4 years of follow-up. Journal Of Clinical Oncology 2023, 41: 4505-4505. DOI: 10.1200/jco.2023.41.16_suppl.4505.Peer-Reviewed Original ResearchAdverse eventsCohort ASafety profileSkin reactionsPD-1/PD-L1 inhibitor monotherapyCommon treatment-emergent adverse eventsCommon treatment-related adverse eventsOngoing phase 3 studiesPD-L1 inhibitor monotherapySystemic anti-cancer therapyTreatment-emergent adverse eventsTreatment-related adverse eventsCarboplatin-based chemotherapyCarboplatin-based therapyCisplatin-ineligible patientsManageable safety profilePhase 1b/2 studySafety/tolerabilityKey secondary endpointMetastatic urothelial carcinomaAvailable therapeutic optionsPhase 3 studySevere skin reactionsLong-term outcomesNew safety concernsA phase III randomized trial of eribulin (E) with or without gemcitabine vs standard of care (SOC) for metastatic urothelial carcinoma (UC) refractory to or ineligible for PD/PDL1 antibody (Ab): SWOG S1937.
Sadeghi S, Plets M, Lara P, Tangen C, Bangs R, Lerner S, Flaig T, Petrylak D, Thompson I. A phase III randomized trial of eribulin (E) with or without gemcitabine vs standard of care (SOC) for metastatic urothelial carcinoma (UC) refractory to or ineligible for PD/PDL1 antibody (Ab): SWOG S1937. Journal Of Clinical Oncology 2023, 41: tps581-tps581. DOI: 10.1200/jco.2023.41.6_suppl.tps581.Peer-Reviewed Original ResearchStandard of careObjective response rateMedian overall survivalProgression-free survivalMedian progression-free survivalMetastatic urothelial carcinomaOverall survivalUrothelial carcinomaMetastatic UCPlatinum-based first-line chemotherapyCurrent SOCCisplatin-ineligible patientsCommon genitourinary cancerCommon grade 3Non-platinum regimenFirst-line chemotherapyPhase IIIStandard dosingIneligible patientsLine chemotherapyMedian OSPrior regimensFree survivalFGFR alterationsGenitourinary cancers
2022
Efficacy and safety of pembrolizumab in metastatic urothelial carcinoma: results from KEYNOTE-045 and KEYNOTE-052 after up to 5 years of follow-up ☆
Balar A, Castellano D, Grivas P, Vaughn D, Powles T, Vuky J, Fradet Y, Lee J, Fong L, Vogelzang N, Climent M, Necchi A, Petrylak D, Plimack E, Xu J, Imai K, Moreno B, Bellmunt J, de Wit R, O’Donnell P. Efficacy and safety of pembrolizumab in metastatic urothelial carcinoma: results from KEYNOTE-045 and KEYNOTE-052 after up to 5 years of follow-up ☆. Annals Of Oncology 2022, 34: 289-299. PMID: 36494006, DOI: 10.1016/j.annonc.2022.11.012.Peer-Reviewed Original ResearchConceptsMetastatic urothelial carcinomaBlinded independent central reviewCisplatin-ineligible patientsObjective response rateRECIST version 1.1Years of followUrothelial carcinomaKEYNOTE-045KEYNOTE-052Primary endpointMost treatment-related adverse eventsResponse rateSurvival rateConfirmed objective response rateTreatment-related adverse eventsProgression-free survival ratesFurther safety concernsPlatinum-containing chemotherapyFirst-line therapyImmune checkpoint inhibitorsNew safety signalsProgression-free survivalDurability of responseFirst-line pembrolizumabOverall survival rateFORT-1: Phase II/III Study of Rogaratinib Versus Chemotherapy in Patients With Locally Advanced or Metastatic Urothelial Carcinoma Selected Based on FGFR1/3 mRNA Expression
Sternberg CN, Petrylak DP, Bellmunt J, Nishiyama H, Necchi A, Gurney H, Lee JL, van der Heijden MS, Rosenbaum E, Penel N, Pang ST, Li JR, del Muro X, Joly F, Pápai Z, Bao W, Ellinghaus P, Lu C, Sierecki M, Coppieters S, Nakajima K, Ishida TC, Quinn DI. FORT-1: Phase II/III Study of Rogaratinib Versus Chemotherapy in Patients With Locally Advanced or Metastatic Urothelial Carcinoma Selected Based on FGFR1/3 mRNA Expression. Journal Of Clinical Oncology 2022, 41: 629-639. PMID: 36240478, PMCID: PMC9870218, DOI: 10.1200/jco.21.02303.Peer-Reviewed Original ResearchConceptsMetastatic urothelial carcinomaUrothelial carcinomaOverall survivalComparable efficacyPan-fibroblast growth factor receptor inhibitorPhase II/III studyPrior platinum-containing regimenPhase II/IIIMRNA overexpressionGrowth factor receptor inhibitorsFGFR-directed therapiesGrade 3/4 eventsMedian overall survivalPlatinum-containing regimenPrimary end pointAdvanced urothelial carcinomaOpen-label trialDNA alterationsVersus ChemotherapyIII studyManageable safetyPlatinum chemotherapyResponse rate analysisReceptor inhibitorsInterim analysisA phase III randomized trial of eribulin (E) with or without gemcitabine versus standard of care (SOC) for metastatic urothelial carcinoma (UC) refractory to or ineligible for PD/PDL1 antibody (Ab): SWOG S1937.
Sadeghi S, Plets M, Lara P, Tangen C, Bangs R, Lerner S, Flaig T, Petrylak D, Thompson I. A phase III randomized trial of eribulin (E) with or without gemcitabine versus standard of care (SOC) for metastatic urothelial carcinoma (UC) refractory to or ineligible for PD/PDL1 antibody (Ab): SWOG S1937. Journal Of Clinical Oncology 2022, 40: tps4608-tps4608. DOI: 10.1200/jco.2022.40.16_suppl.tps4608.Peer-Reviewed Original ResearchStandard of careMedian overall survivalObjective response rateProgression-free survivalMedian progression-free survivalMetastatic urothelial carcinomaOverall survivalUrothelial carcinomaMetastatic UCPlatinum-based first-line chemotherapyCurrent SOCCisplatin-ineligible patientsCommon genitourinary cancerCommon grade 3Non-platinum regimenFirst-line chemotherapyPhase IIIStandard dosingIneligible patientsLine chemotherapyMedian OSPrior regimensFree survivalFGFR alterationsGenitourinary cancersLong-term outcomes in EV-301: 24-month findings from the phase 3 trial of enfortumab vedotin versus chemotherapy in patients with previously treated advanced urothelial carcinoma.
Rosenberg J, Powles T, Sonpavde G, Loriot Y, Duran I, Lee J, Matsubara N, Vulsteke C, Castellano D, Mamtani R, Wu C, Matsangou M, Campbell M, Petrylak D. Long-term outcomes in EV-301: 24-month findings from the phase 3 trial of enfortumab vedotin versus chemotherapy in patients with previously treated advanced urothelial carcinoma. Journal Of Clinical Oncology 2022, 40: 4516-4516. DOI: 10.1200/jco.2022.40.16_suppl.4516.Peer-Reviewed Original ResearchProgression-free survivalOverall survivalStandard chemotherapyUrothelial carcinomaInterim analysisInvestigator-assessed progression-free survivalLong-term clinical profilesPrior platinum-containing chemotherapyTreatment-related adverse eventsPrespecified interim analysisRobust clinical benefitTolerable safety profileAdvanced urothelial carcinomaMedian overall survivalMetastatic urothelial carcinomaPlatinum-containing chemotherapyNew safety signalsPhase 3 trialRate of gradeLonger overall survivalLong-term outcomesStandard of careAntibody-drug conjugatesConsistent survival advantageOS benefitAvelumab first-line (1L) maintenance for advanced urothelial carcinoma (UC): Long-term follow-up results from the JAVELIN Bladder 100 trial.
Powles T, Park H, Voog E, Caserta C, Pérez-Valderrama B, Gurney H, Loriot Y, Sridhar S, Tsuchiya N, Sternberg C, Bellmunt J, Aragon-Ching J, Petrylak D, Blake-Haskins A, Laliberte R, Wang J, Costa N, Grivas P. Avelumab first-line (1L) maintenance for advanced urothelial carcinoma (UC): Long-term follow-up results from the JAVELIN Bladder 100 trial. Journal Of Clinical Oncology 2022, 40: 487-487. DOI: 10.1200/jco.2022.40.6_suppl.487.Peer-Reviewed Original ResearchBest supportive careAdvanced urothelial carcinomaProgression-free survivalPlatinum-containing chemotherapyUrothelial carcinomaOverall survivalPD-L1Metastatic urothelial carcinomaNew safety signalsLonger overall survivalLong-term followStandard of careLong-term safetyFirst-line maintenanceAnticancer drug therapyOS benefitProlonged OSMonotherapy studiesPrimary endpointSecondary endpointsAlone armPrespecified subgroupsSupportive careTreatment guidelinesDrug therapyImpact of primary tumor location on efficacy and safety of pembrolizumab (pembro) in patients (pts) with locally advanced or metastatic urothelial carcinoma (UC) enrolled in the phase 2 KEYNOTE-052 and phase 3 KEYNOTE-045 trials.
O'Donnell P, Balar A, Castellano D, De Wit R, Vaughn D, Powles T, Vuky J, Lee J, Fradet Y, Bellmunt J, Fong L, Petrylak D, Gerritsen W, Quinn D, Culine S, Bajorin D, Xu J, Imai K, Moreno B, Grivas P. Impact of primary tumor location on efficacy and safety of pembrolizumab (pembro) in patients (pts) with locally advanced or metastatic urothelial carcinoma (UC) enrolled in the phase 2 KEYNOTE-052 and phase 3 KEYNOTE-045 trials. Journal Of Clinical Oncology 2022, 40: 516-516. DOI: 10.1200/jco.2022.40.6_suppl.516.Peer-Reviewed Original ResearchMetastatic urothelial carcinomaPrimary tumor locationKEYNOTE-045KEYNOTE-052Urothelial carcinomaTumor locationRECIST v1.1Primary tumorSafety of pembrolizumabSimilar clinical activityWithdrawal of consentMeasurable diseaseData cutoffManageable safetyUnacceptable toxicitySystemic therapyPD-L1Positive tumorsRenal pelvisDisease progressionPembroSimilar efficacyClinical activityGrade 3UT groupStudy EV-103 cohort L: Evaluating perioperative enfortumab vedotin monotherapy in cis-ineligible muscle invasive bladder cancer (MIBC) (trial in progress).
Hoimes C, Flaig T, Srinivas S, Mar N, Petrylak D, O'Donnell P, Bilen M, Sasse C, Yu Y, Birrenkott M, Rosenberg J. Study EV-103 cohort L: Evaluating perioperative enfortumab vedotin monotherapy in cis-ineligible muscle invasive bladder cancer (MIBC) (trial in progress). Journal Of Clinical Oncology 2022, 40: tps587-tps587. DOI: 10.1200/jco.2022.40.6_suppl.tps587.Peer-Reviewed Original ResearchMuscle-invasive bladder cancerMetastatic urothelial carcinomaCentral pathology reviewPerioperative therapyPathology reviewMicrotubule-disrupting agent monomethyl auristatin EPathological complete response ratePelvic lymph node dissectionBlinded independent central reviewPathological downstaging rateTolerable safety profileComplete response rateOverall survival benefitDisease-free survivalEvent-free survivalHigh-risk featuresLymph node dissectionPhase 3 studyPD-L1 inhibitorsInvasive bladder cancerIndependent central reviewPlatinum-based therapyMonomethyl auristatin ECurrent standardAntibody-drug conjugatesRandomized phase II trial of gemcitabine, avelumab and carboplatin versus no neoadjuvant therapy preceding surgery for cisplatin-ineligible muscle-invasive urothelial carcinoma (MIUC): SWOG GAP trial (S2011).
Sonpavde G, Plets M, Liss M, Meeks J, Petrylak D, Cole S, McKay R, Gupta S, Hita S, Pereira T, Bangs R, Tangen C, Thompson I, Lerner S. Randomized phase II trial of gemcitabine, avelumab and carboplatin versus no neoadjuvant therapy preceding surgery for cisplatin-ineligible muscle-invasive urothelial carcinoma (MIUC): SWOG GAP trial (S2011). Journal Of Clinical Oncology 2022, 40: tps591-tps591. DOI: 10.1200/jco.2022.40.6_suppl.tps591.Peer-Reviewed Original ResearchMuscle-invasive urothelial carcinomaMuscle-invasive bladder cancerUpper tract urothelial carcinomaImmune checkpoint inhibitorsWeeks x 4 cyclesPathologic complete remissionEvent-free survivalPhase II trialUpfront surgeryUrothelial carcinomaDay 1II trialNeoadjuvant therapyOverall survivalHigh-risk upper tract urothelial carcinomaCisplatin-ineligible metastatic urothelial carcinomaNeoadjuvant cisplatin-based combination chemotherapyOpen-label phase II trialHigh grade upper tract urothelial carcinomaNeoadjuvant immune checkpoint inhibitorsRandomized phase II trialCisplatin-based combination chemotherapyCisplatin-eligible patientsMetastatic urothelial carcinomaPD-L1 inhibitors
2021
Avelumab first-line (1L) maintenance for advanced urothelial carcinoma (UC): Analysis of clinical and genomic subgroups from the JAVELIN Bladder 100 trial.
Powles T, Petrylak D, Park H, Sridhar S, Caserta C, Vuillemin A, Lee H, Bellmunt J, Yamamoto Y, Aragon-Ching J, Huang B, Ching K, Davis C, Di Pietro A, Loriot Y, Grivas P. Avelumab first-line (1L) maintenance for advanced urothelial carcinoma (UC): Analysis of clinical and genomic subgroups from the JAVELIN Bladder 100 trial. Journal Of Clinical Oncology 2021, 39: 4520-4520. DOI: 10.1200/jco.2021.39.15_suppl.4520.Peer-Reviewed Original ResearchBest supportive careAdvanced urothelial carcinomaOverall survivalUrothelial carcinomaPD-L1OS benefitGenomic subtypesMetastatic urothelial carcinomaPlatinum-containing chemotherapyPlatinum-based chemotherapyProlonged overall survivalStandard of careFirst-line maintenanceGenomic subgroupsSubgroups of interestBSC armEligible ptsUnresectable diseasePrimary endpointSupportive careCancer Genome AtlasLymph nodesTract tumorsDisease stageTCGA subtypesEnfortumab vedotin in cisplatin-ineligible patients with locally advanced or metastatic urothelial cancer who received prior PD-1/PD-L1 inhibitors: An updated analysis of EV-201 Cohort 2.
McGregor B, Balar A, Rosenberg J, Van Der Heijden M, Park H, Lee J, Kojima T, Harrison M, Heath E, Stein M, Loriot Y, Necchi A, Steinberg J, Liang S, Trowbridge J, Petrylak D, Yu E. Enfortumab vedotin in cisplatin-ineligible patients with locally advanced or metastatic urothelial cancer who received prior PD-1/PD-L1 inhibitors: An updated analysis of EV-201 Cohort 2. Journal Of Clinical Oncology 2021, 39: 4524-4524. DOI: 10.1200/jco.2021.39.15_suppl.4524.Peer-Reviewed Original ResearchBlinded independent central reviewObjective response rateProgression-free survivalDuration of responseComplete responsePD-1/PD-L1 inhibitorsPrimary analysisConfirmed objective response rateCisplatin-ineligible patientsMetastatic urothelial cancerMetastatic urothelial carcinomaOverall survival benefitPeripheral sensory neuropathyPlatinum-containing chemotherapyNew safety signalsPD-L1 inhibitorsIndependent central reviewPrimary tumor siteOnset of responseAntibody-drug conjugatesPrior platinumPrimary endpointRECIST 1.1Secondary endpointsAdverse eventsStudy 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