2024
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.
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 EORRAvelumab first-line (1L) maintenance for advanced urothelial carcinoma (aUC): Long-term outcomes from the JAVELIN Bladder 100 trial in patients (pts) with histological subtypes.
Loriot Y, Gupta S, Powles T, Grivas P, Petrylak D, Tyroller K, Jacob N, Hoffman J, Bellmunt J. Avelumab first-line (1L) maintenance for advanced urothelial carcinoma (aUC): Long-term outcomes from the JAVELIN Bladder 100 trial in patients (pts) with histological subtypes. Journal Of Clinical Oncology 2024, 42: 4567-4567. DOI: 10.1200/jco.2024.42.16_suppl.4567.Peer-Reviewed Original ResearchAdvanced urothelial carcinomaTreatment-related adverse eventsPlatinum-based chemotherapyProgression-free survivalBSC-alone armHistological subtypesLong-term outcomesOverall survivalPost hoc analysisTreatment guidelinesAnalysis of long-term outcomesStandard-of-care treatmentMedian follow-upOverall populationLong-term efficacyInternational treatment guidelinesLong-term safetyJAVELIN BladderMetastatic UCSafety populationData cutoffEligible ptsUrothelial carcinomaFirst-linePrimary endpoint
2023
Safety analysis by UGT1A1 status of TROPHY-U-01 cohort 1, a phase 2 study of sacituzumab govitecan (SG) in patients (pts) with metastatic urothelial cancer (mUC) who progressed after platinum (PT)-based chemotherapy and a checkpoint inhibitor (CPI).
Loriot Y, Petrylak D, Rezazadeh A, Flechon A, Jain R, Gupta S, Bupathi M, Beuzeboc P, Palmbos P, Kyriakopoulos C, Pouessel D, Sternberg C, Tonelli J, Sierecki M, Zhou H, Grivas P, Barthelemy P, Balar A, Tagawa S. Safety analysis by UGT1A1 status of TROPHY-U-01 cohort 1, a phase 2 study of sacituzumab govitecan (SG) in patients (pts) with metastatic urothelial cancer (mUC) who progressed after platinum (PT)-based chemotherapy and a checkpoint inhibitor (CPI). Journal Of Clinical Oncology 2023, 41: 4514-4514. DOI: 10.1200/jco.2023.41.16_suppl.4514.Peer-Reviewed Original ResearchObjective response rateMetastatic urothelial cancerSacituzumab govitecanUGT1A1 statusCheckpoint inhibitorsOverall survivalSafety profileSafety outcomesECOG PS 0Treatment-related discontinuationsManageable safety profileMedian overall survivalPhase 2 studyChronic kidney diseasePrior reportsCoronary artery diseaseAdverse event occurrenceAntibody-drug conjugatesBaseline comorbiditiesDose interruptionPrimary endpointPrior therapyRECIST 1.1PS 0Adverse eventsEnfortumab vedotin (EV) with or without pembrolizumab (P) in patients (pts) who are cisplatin-ineligible with previously untreated locally advanced or metastatic urothelial cancer (la/mUC): Additional 3-month follow-up on cohort K data.
Friedlander T, Milowsky M, O'Donnell P, Petrylak D, Hoimes C, Flaig T, Mar N, Moon H, McKay R, Bilen M, Borchiellini D, Iafolla M, Carret A, Yu Y, Guseva M, Kataria R, Rosenberg J. Enfortumab vedotin (EV) with or without pembrolizumab (P) in patients (pts) who are cisplatin-ineligible with previously untreated locally advanced or metastatic urothelial cancer (la/mUC): Additional 3-month follow-up on cohort K data. Journal Of Clinical Oncology 2023, 41: 4568-4568. DOI: 10.1200/jco.2023.41.16_suppl.4568.Peer-Reviewed Original ResearchProgression-free survivalDisease control rateDuration of responseMedian DORMedian progression-free survivalBlinded independent central reviewOverall survivalPFS rateAdverse eventsOS ratesSkin reactionsTreatment-emergent adverse eventsTreatment-related adverse eventsFirst-line treatment optionManageable safety profileObjective response ratePD-1 inhibitorsMetastatic urothelial cancerSevere skin reactionsIndependent central reviewNew safety concernsHigh unmet needImmunogenic cell deathRECIST v1.1Primary endpointEfficacy of sacituzumab govitecan (SG) in locally advanced (LA) or metastatic urothelial cancer (mUC) by trophoblast cell surface antigen 2 (Trop-2) expression.
Loriot Y, Balar A, Petrylak D, Rezazadeh A, Grivas P, Flechon A, Jain R, Agarwal N, Bupathi M, Barthelemy P, Beuzeboc P, Palmbos P, Kyriakopoulos C, Pouessel D, Sternberg C, Tonelli J, Elboudwarej E, Diehl L, Jürgensmeier J, Tagawa S. Efficacy of sacituzumab govitecan (SG) in locally advanced (LA) or metastatic urothelial cancer (mUC) by trophoblast cell surface antigen 2 (Trop-2) expression. Journal Of Clinical Oncology 2023, 41: 4579-4579. DOI: 10.1200/jco.2023.41.16_suppl.4579.Peer-Reviewed Original ResearchObjective response rateMetastatic urothelial cancerProgression-free survivalTrop-2 expressionMedian progression-free survivalSacituzumab govitecanArchival tumor samplesH-scoreCheckpoint inhibitorsUnstratified Cox proportional hazards modelAnti-Trop-2 antibodyTrop-2 protein expressionTumor samplesCox proportional hazards modelTumor cellsAccelerated FDA approvalOverall survival rateC1-3Proportional hazards modelMedian OSBaseline characteristicsData cutoffEfficacy endpointEfficacy outcomesPrimary endpointFirst-in-class oral innate immune activator BXCL701 combined with pembrolizumab, in patients with metastatic castration-resistant prostate cancer (mCRPC) of small cell neuroendocrine (SCNC) variant: Randomized phase 2b trial.
Aggarwal R, Zhang J, Monk P, Zhu X, Costin D, Petrylak D, Borderies P, Deshpande R, Hafeez A, O'Neill V, Tagawa S. First-in-class oral innate immune activator BXCL701 combined with pembrolizumab, in patients with metastatic castration-resistant prostate cancer (mCRPC) of small cell neuroendocrine (SCNC) variant: Randomized phase 2b trial. Journal Of Clinical Oncology 2023, 41: tps5109-tps5109. DOI: 10.1200/jco.2023.41.16_suppl.tps5109.Peer-Reviewed Original ResearchMetastatic castration-resistant prostate cancerSerious adverse eventsPartial responsePrimary endpointPhase 2aRandomized Phase 2b TrialCastration-resistant prostate cancerOral small-molecule inhibitorPhase 2b trialPrime immune cellsRECIST 1.1 criteriaDisease control rateImmune checkpoint inhibitorsPhase 2 studyPlatinum-based chemotherapyDuration of responsePotential predictive biomarkersImmune effector cellsMeasurable diseaseNeuroendocrine variantPSA-PFSRECIST 1.1Safety populationCheckpoint inhibitorsData cutoffFirst-in-class oral innate immune activator BXCL701 combined with pembrolizumab in patients with metastatic, castration-resistant prostate cancer (mCRPC) of small cell neuroendocrine (SCNC) phenotype: Phase 2a final results.
Aggarwal R, Zhang J, Zhu X, Monk P, Jones R, Linch M, Costin D, De Bono J, Karsh L, Petrylak D, Borderies P, Deshpande R, Hafeez A, O'Neill V, Tagawa S. First-in-class oral innate immune activator BXCL701 combined with pembrolizumab in patients with metastatic, castration-resistant prostate cancer (mCRPC) of small cell neuroendocrine (SCNC) phenotype: Phase 2a final results. Journal Of Clinical Oncology 2023, 41: 176-176. DOI: 10.1200/jco.2023.41.6_suppl.176.Peer-Reviewed Original ResearchEvaluable patientsMedian durationDay 1Castration-resistant prostate cancerOral small-molecule inhibitorEncouraging anti-tumor activityImmune-related AEPrime immune cellsAcceptable safety profilePhase 2 studyDurability of responsePlatinum-based chemotherapyImmune effector cellsStandard of careAnti-tumor activityComposite respondersRECIST respondersBID dosingCheckpoint inhibitorsMCRPC patientsPrimary endpointRECIST 1.1Acceptable tolerabilityAdverse eventsCytotoxic chemotherapyPembrolizumab plus docetaxel for patients with metastatic castration-resistant prostate cancer (mCRPC): Randomized, double-blind, phase 3 KEYNOTE-921 study.
Petrylak D, Ratta R, Matsubara N, Korbenfeld E, Gafanov R, Mourey L, Todenhöfer T, Gurney H, Kramer G, Bergman A, Zalewski P, De Santis M, Armstrong A, Gerritsen W, Pachynski R, Byun S, Li X, Schloss C, Poehlein C, Fizazi K. Pembrolizumab plus docetaxel for patients with metastatic castration-resistant prostate cancer (mCRPC): Randomized, double-blind, phase 3 KEYNOTE-921 study. Journal Of Clinical Oncology 2023, 41: 19-19. DOI: 10.1200/jco.2023.41.6_suppl.19.Peer-Reviewed Original ResearchMetastatic castration-resistant prostate cancerNext-generation hormonal agentsDual primary endpointsTreatment-related AEsCycles of docetaxelPrimary endpointSecondary endpointsDocetaxel armRadiographic progression-free survivalCastration-resistant prostate cancerBlinded independent central reviewCycles of placeboData cutoff dateSafety of pembrolizumabSubsequent anticancer therapyTreatment-related deathsAndrogen deprivation therapyECOG performance statusKey secondary endpointProgression-free survivalIndependent central reviewEligible ptsDeprivation therapyRECIST 1.1Baseline characteristicsEnfortumab 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 endpointsUpdated outcomes in TROPHY-U-01 cohort 1, a phase 2 study of sacituzumab govitecan (SG) in patients (pts) with metastatic urothelial cancer (mUC) that progressed after platinum (PT)-based chemotherapy and a checkpoint inhibitor (CPI).
Tagawa S, Balar A, Petrylak D, Rezazadeh A, Loriot Y, Flechon A, Jain R, Agarwal N, Bupathi M, Barthelemy P, Beuzeboc P, Palmbos P, Kyriakopoulos C, Pouessel D, Sternberg C, Tonelli J, Sierecki M, Zhou H, Grivas P. Updated outcomes in TROPHY-U-01 cohort 1, a phase 2 study of sacituzumab govitecan (SG) in patients (pts) with metastatic urothelial cancer (mUC) that progressed after platinum (PT)-based chemotherapy and a checkpoint inhibitor (CPI). Journal Of Clinical Oncology 2023, 41: 526-526. DOI: 10.1200/jco.2023.41.6_suppl.526.Peer-Reviewed Original ResearchMetastatic urothelial cancerTreatment-related adverse eventsObjective response rateProgression-free survivalDuration of responseClinical benefit ratePhase 2 studyCheckpoint inhibitorsSacituzumab govitecanOverall survivalPrior therapyCentral reviewResponse rateAnti-Trop-2 antibodyAccelerated FDA approvalECOG PS 0Last prior therapyTreatment-related deathsKey secondary endpointNew safety signalsFebrile neutropeniaOS ratesData cutoffPrimary endpointRECIST 1.1
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 rateAvelumab 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 therapy
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 eventsEfficacy of enzalutamide (ENZA) plus androgen deprivation therapy (ADT) in men with de novo (M1) metastatic hormone-sensitive prostate cancer (mHSPC) versus progression to mHSPC (M0): Post hoc analysis of the phase III ARCHES trial.
Azad A, Villers A, Alekseev B, Szmulewitz R, Alcaraz A, Shore N, Petrylak D, Holzbeierlein J, Gomez-Veiga F, Rosbrook B, Zohren F, Lee H, Haas G, Iguchi T, Stenzl A, Armstrong A. Efficacy of enzalutamide (ENZA) plus androgen deprivation therapy (ADT) in men with de novo (M1) metastatic hormone-sensitive prostate cancer (mHSPC) versus progression to mHSPC (M0): Post hoc analysis of the phase III ARCHES trial. Journal Of Clinical Oncology 2021, 39: 102-102. DOI: 10.1200/jco.2021.39.6_suppl.102.Peer-Reviewed Original ResearchMetastatic hormone-sensitive prostate cancerEfficacy of enzalutamideAndrogen deprivation therapyDe novo metastatic hormone-sensitive prostate cancerM1 diseaseInitial diagnosisProstate-specific antigenSecondary endpointsDisease volumeTreatment armsHormone-sensitive prostate cancerProgression-free survival eventsPrior docetaxel useKey secondary endpointNew antineoplastic therapiesDeprivation therapyDocetaxel usePrior docetaxelEfficacy outcomesPrimary endpointPSA progressionBaseline characteristicsObjective responseClinical benefitSafety profileSapanisertib, a dual mTORC1/2 inhibitor, for TSC1- or TSC2- mutated metastatic urothelial carcinoma (mUC).
Kim J, Milowsky M, Hahn N, Kwiatkowski D, Morgans A, Davis N, Appleman L, Gupta S, Lara P, Hoffman-Censits J, Quinn D, Shyr Y, LoRusso P, Sklar J, Petrylak D. Sapanisertib, a dual mTORC1/2 inhibitor, for TSC1- or TSC2- mutated metastatic urothelial carcinoma (mUC). Journal Of Clinical Oncology 2021, 39: 431-431. DOI: 10.1200/jco.2021.39.6_suppl.431.Peer-Reviewed Original ResearchMetastatic urothelial carcinomaStable diseaseAdverse eventsObjective responseWithdrew consentTSC2 mutationsUrothelial carcinomaTSC1 mutationsTumor samplesCommon adverse eventsMedian overall survivalTreatment-related deathsPhase II studyCentral labOverall response rateDual mTORC1/2 inhibitorUnknown mutational statusCentral confirmationEligible patientsEvaluable patientsMUC patientsRestaging scanII studyPrimary endpointBaseline characteristics
2020
Maintenance avelumab + best supportive care (BSC) versus BSC alone after platinum-based first-line (1L) chemotherapy in advanced urothelial carcinoma (UC): JAVELIN Bladder 100 phase III interim analysis.
Powles T, Park S, Voog E, Caserta C, Valderrama B, Gurney H, Kalofonos H, Radulovic S, Demey W, Ullén A, Loriot Y, Sridhar S, Tsuchiya N, Kopyltsov E, Sternberg C, Bellmunt J, Aragon-Ching J, Petrylak D, di Pietro A, Grivas P. Maintenance avelumab + best supportive care (BSC) versus BSC alone after platinum-based first-line (1L) chemotherapy in advanced urothelial carcinoma (UC): JAVELIN Bladder 100 phase III interim analysis. Journal Of Clinical Oncology 2020, 38: lba1-lba1. DOI: 10.1200/jco.2020.38.18_suppl.lba1.Peer-Reviewed Original ResearchBest supportive careAdvanced urothelial carcinomaProgression-free survivalMedian overall survivalOverall survivalPlatinum-based chemotherapyPD-L1Urothelial carcinomaAdverse eventsSupportive carePlatinum-based first-line chemotherapyCausality adverse eventsCycles of gemcitabineFirst-line chemotherapyMetastatic urothelial carcinomaPhase 3 trialUrinary tract infectionIndependent central reviewEligible patientsNonvisceral diseaseOS benefitStable diseaseMaintenance therapyPrimary endpointSecondary endpointsEfficacy of enzalutamide (ENZA) + androgen deprivation therapy (ADT) in metastatic hormone-sensitive prostate cancer (mHSPC) by pattern of metastatic spread: ARCHES post hoc analyses.
Shore N, Armstrong A, Szmulewitz R, Petrylak D, Holzbeierlein J, Villers A, Azad A, Alcaraz A, Alekseev B, Iguchi T, Gomez-Veiga F, Rosbrook B, Lee H, Haas G, Stenzl A. Efficacy of enzalutamide (ENZA) + androgen deprivation therapy (ADT) in metastatic hormone-sensitive prostate cancer (mHSPC) by pattern of metastatic spread: ARCHES post hoc analyses. Journal Of Clinical Oncology 2020, 38: 5547-5547. DOI: 10.1200/jco.2020.38.15_suppl.5547.Peer-Reviewed Original ResearchRadiographic progression-free survivalEfficacy of enzalutamideAndrogen deprivation therapyMetastatic hormone-sensitive prostate cancerSymptomatic skeletal eventsSoft tissue metastasesMetastatic spreadVisceral metastasesSecondary endpointsBone metastasesFirst symptomatic skeletal eventHormone-sensitive prostate cancerProstate-specific antigen progressionLarge patient subgroupPrior docetaxel treatmentProgression-free survivalSecondary endpoint measuresGreater relative efficacyNew antineoplastic therapiesM0 patientsDeprivation therapyPrimary endpointSkeletal eventsCastration resistanceDisease volumeInfigratinib and treatment response in advanced/unresectable or metastatic urothelial carcinoma in first-line and later-line treatment settings.
Lyou Y, Grivas P, Rosenberg J, Hoffman-Censits J, Quinn D, Petrylak D, Galsky M, Vaishampayan U, De Giorgi U, Gupta S, Burris III H, Rearden J, Andresen C, Wang H, Daneshmand S, Bajorin D, Pal S. Infigratinib and treatment response in advanced/unresectable or metastatic urothelial carcinoma in first-line and later-line treatment settings. Journal Of Clinical Oncology 2020, 38: 5038-5038. DOI: 10.1200/jco.2020.38.15_suppl.5038.Peer-Reviewed Original ResearchUpper tract urothelial carcinomaMetastatic urothelial carcinomaTyrosine kinase inhibitorsPlatinum-based chemotherapyUrothelial bladder carcinomaUrothelial carcinomaTreatment responsePrior platinum-based chemotherapyDisease control rateObjective response rateMutations/fusionsConsistent treatment responseEligible patientsResected diseaseSalvage therapyPrimary endpointPrior linesFGFR3 alterationsLine treatmentControl rateBladder carcinomaSubgroup analysisOutcome measuresPatientsTreatment settingsStudy 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-L1