2024
Avelumab first-line maintenance (1LM) for advanced urothelial carcinoma (aUC): Long-term outcomes from JAVELIN Bladder 100 in patients (pts) with low tumor burden.
Bellmunt J, Powles T, Park S, Voog E, Valderrama B, Gurney H, Ullén A, Loriot Y, Sridhar S, Tsuchiya N, Sternberg C, Aragon-Ching J, Petrylak D, Climent Duran M, Tyroller K, Hoffman J, Jacob N, Grivas P, Gupta S. Avelumab first-line maintenance (1LM) for advanced urothelial carcinoma (aUC): Long-term outcomes from JAVELIN Bladder 100 in patients (pts) with low tumor burden. Journal Of Clinical Oncology 2024, 42: 4566-4566. DOI: 10.1200/jco.2024.42.16_suppl.4566.Peer-Reviewed Original ResearchAdvanced urothelial carcinomaLow tumor burdenProgression-free survivalBest supportive carePlatinum-based chemotherapyTreatment-related adverse eventsTumor burdenOverall survivalNonvisceral metastasesPost hoc analysisIncidence of treatment-related adverse eventsPost-hoc analysis of efficacyFirst-line maintenanceImmune checkpoint inhibitorsMedian follow-upProlonged overall survivalAssociated with better outcomesAnalysis of efficacyLong-term outcomesAnticancer drug treatmentJAVELIN BladderLA diseaseNonvisceral diseaseCheckpoint inhibitorsMetastatic UCSacituzumab Govitecan in Combination With Pembrolizumab for Patients With Metastatic Urothelial Cancer That Progressed After Platinum-Based Chemotherapy: TROPHY-U-01 Cohort 3
Grivas P, Pouessel D, Park C, Barthelemy P, Bupathi M, Petrylak D, Agarwal N, Gupta S, Fléchon A, Ramamurthy C, Davis N, Recio-Boiles A, Sternberg C, Bhatia A, Pichardo C, Sierecki M, Tonelli J, Zhou H, Tagawa S, Loriot Y. Sacituzumab Govitecan in Combination With Pembrolizumab for Patients With Metastatic Urothelial Cancer That Progressed After Platinum-Based Chemotherapy: TROPHY-U-01 Cohort 3. Journal Of Clinical Oncology 2024, 42: 1415-1425. PMID: 38261969, PMCID: PMC11095901, DOI: 10.1200/jco.22.02835.Peer-Reviewed Original ResearchMetastatic urothelial cancerPlatinum-based chemotherapyClinical benefit rateProgression-free survivalDuration of responseSacituzumab govitecanCheckpoint inhibitorsCohort 3Central reviewUrothelial cancerFirst-line platinum-based chemotherapyOpen-label phase II studyDay 1Median duration of responseMedian progression-free survivalTreatment-related adverse eventsMedian overall survivalMedian follow-upPhase II studySecondary end pointsAntibody-drug conjugatesMetastatic settingOverall survivalStandard therapyII studyTROPHY-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 conjugates
2023
Efficacy 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 cutoffSafety 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 eventsFirst-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 chemotherapyUpdated 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
BXCL701: First-in-class oral activator of systemic innate immunity combined with pembrolizumab, in patients with metastatic castration-resistant prostate cancer (mCRPC) of small-cell neuroendocrine carcinoma (SCNC) phenotype—Phase 2a interim results.
Tagawa S, Zhang J, Monk P, Zhu X, Jones R, Linch M, Costin D, De Bono J, Karsh L, Petrylak D, Borderies P, Deshpande R, O'Neill V, Aggarwal R. BXCL701: First-in-class oral activator of systemic innate immunity combined with pembrolizumab, in patients with metastatic castration-resistant prostate cancer (mCRPC) of small-cell neuroendocrine carcinoma (SCNC) phenotype—Phase 2a interim results. Journal Of Clinical Oncology 2022, 40: 126-126. DOI: 10.1200/jco.2022.40.6_suppl.126.Peer-Reviewed Original ResearchSmall cell neuroendocrine carcinomaMetastatic castration-resistant prostate cancerEvaluable patientsAnti-tumor activityPrior linesCastration-resistant prostate cancerOral small-molecule inhibitorEncouraging anti-tumor activityBone-only diseaseComposite response rateImmune-related AEPhase 1b/2 studyPrime immune cellsSystemic innate immunityAcceptable safety profileImmune effector cellsStandard of careInterim resultsStage 1Prior chemotherapyRECIST 1.1Unconfirmed PRBID dosingCheckpoint inhibitorsMCRPC patientsTROPHY-U-01 Cohort 3: Sacituzumab govitecan (SG) in combination with pembrolizumab (Pembro) in patients (pts) with metastatic urothelial cancer (mUC) who progressed after platinum (PLT)-based regimens.
Grivas P, Pouessel D, Park C, Barthélémy P, Bupathi M, Petrylak D, Agarwal N, Flechon A, Ramamurthy C, Davis N, Recio-Boiles A, Tagawa S, Sternberg C, Bhatia A, Pichardo C, Goswami T, Loriot Y. TROPHY-U-01 Cohort 3: Sacituzumab govitecan (SG) in combination with pembrolizumab (Pembro) in patients (pts) with metastatic urothelial cancer (mUC) who progressed after platinum (PLT)-based regimens. Journal Of Clinical Oncology 2022, 40: 434-434. DOI: 10.1200/jco.2022.40.6_suppl.434.Peer-Reviewed Original ResearchObjective response rateTreatment-emergent adverse eventsMetastatic urothelial cancerInvestigator-assessed objective response ratePhase 2 trialProgression-free survivalSacituzumab govitecanCheckpoint inhibitorsEastern Cooperative Oncology Group performance status 0Most common treatment-emergent adverse eventsCommon treatment-emergent adverse eventsSolid Tumors version 1.1Long-term disease controlBlinded independent central reviewAntigen 2 antibodiesClinical benefit rateECOG PS 1Manageable safety profileMedian overall survivalPerformance status 0Phase 2 doseTreatment-related AEsTreatment-related deathsTreatment-related gradeNew safety signals
2021
First-in-human, phase I study of PF-06753512, a vaccine-based immunotherapy regimen (PrCa VBIR), in biochemical relapse (BCR) and metastatic castration-resistant prostate cancer (mCRPC).
Autio K, Higano C, Nordquist L, Appleman L, Zhang T, Zhu X, Babiker H, Vogelzang N, Prasad S, Schweizer M, Billotte S, Binder J, Cavazos N, Li R, Chan K, Cho H, Dermyer M, Hollingsworth R, Kern K, Petrylak D. First-in-human, phase I study of PF-06753512, a vaccine-based immunotherapy regimen (PrCa VBIR), in biochemical relapse (BCR) and metastatic castration-resistant prostate cancer (mCRPC). Journal Of Clinical Oncology 2021, 39: 2612-2612. DOI: 10.1200/jco.2021.39.15_suppl.2612.Peer-Reviewed Original ResearchMetastatic castration-resistant prostate cancerTreatment-related adverse eventsImmune checkpoint inhibitorsBiochemical relapseImmune responseCastration-resistant prostate cancerPhase INovel hormone therapyAntitumor activityManageable safety profileObjective tumor responsePD-1 antibodyAntigen-specific immunityProstate-specific membrane antigenAndrogen-sensitive diseaseReplication-deficient adenoviral vectorAnti-tumor activityStem cell antigenPC-associated antigensNoticeable antitumor activityAntibody tremelimumabExpansion doseCheckpoint inhibitorsImmunotherapy regimenAdverse events
2020
TROPHY-U-01 cohort 1 final results: A phase II study of sacituzumab govitecan (SG) in metastatic urothelial cancer (mUC) that has progressed after platinum (PLT) and checkpoint inhibitors (CPI)
Loriot Y, Balar A, Petrylak D, Tagawa S, Rezazadeh A, Fléchon A, Jain R, Agarwal N, Bupathi M, Barthélémy P, Beuzeboc P, Palmbos P, Kyriakopoulos C, Pouessel D, Sternberg C, Hong Q, Goswami T, Itri L, Grivas P. TROPHY-U-01 cohort 1 final results: A phase II study of sacituzumab govitecan (SG) in metastatic urothelial cancer (mUC) that has progressed after platinum (PLT) and checkpoint inhibitors (CPI). Annals Of Oncology 2020, 31: s1156. DOI: 10.1016/j.annonc.2020.08.2253.Peer-Reviewed Original ResearchIMvigor010: Primary analysis from a phase III randomized study of adjuvant atezolizumab (atezo) versus observation (obs) in high-risk muscle-invasive urothelial carcinoma (MIUC).
Hussain M, Powles T, Albers P, Castellano D, Daneshmand S, Gschwend J, Nishiyama H, Oudard S, Tayama D, Davarpanah N, Degaonkar V, Shi Y, Mariathasan S, Grivas P, O'Donnell P, Rosenberg J, Geynisman D, Hoffman-Censits J, Petrylak D, Bellmunt J. IMvigor010: Primary analysis from a phase III randomized study of adjuvant atezolizumab (atezo) versus observation (obs) in high-risk muscle-invasive urothelial carcinoma (MIUC). Journal Of Clinical Oncology 2020, 38: 5000-5000. DOI: 10.1200/jco.2020.38.15_suppl.5000.Peer-Reviewed Original ResearchMuscle-invasive urothelial carcinomaDisease-free survivalNeoadjuvant chemoAdjuvant chemoPrimary endpointPrimary analysisECOG PS 0Interim overall survivalLymph node dissectionPD-L1 testingLevel 1 evidenceITT populationObs armPostsurgical radiationCheckpoint inhibitorsGastrointestinal toxicityMainstay treatmentNode dissectionPrimary resectionAdjuvant studiesOverall survivalPS 0Radical surgeryClinical factorsPrimary diseaseDocetaxel with or without Ramucirumab after Platinum-Based Chemotherapy and Checkpoint Inhibitors in Advanced Urothelial Carcinoma: A Pre-Specified Subgroup Analysis from the Phase 3 RANGE Trial
Drakaki A, Kirby C, van der Heijden M, Petrylak D, Powles T, N. K, Fléchon A, Necchi A, Géczi L, Lee J, Gakis G, Bracarda S, Chowdhury S, Lin C, Keizman D, Vaishampayan U, Zimmermann A, Bell-McGuinn K, Castellano D. Docetaxel with or without Ramucirumab after Platinum-Based Chemotherapy and Checkpoint Inhibitors in Advanced Urothelial Carcinoma: A Pre-Specified Subgroup Analysis from the Phase 3 RANGE Trial. Bladder Cancer 2020, 6: 43-52. DOI: 10.3233/blc-190252.Peer-Reviewed Original ResearchImmune checkpoint inhibitorsProgression-free survivalOverall response ratePrior immune checkpoint inhibitorsUrothelial carcinomaCheckpoint inhibitorsPlatinum-refractory metastatic urothelial carcinomaUnstratified Cox proportional hazards modelMedian progression-free survivalPlatinum-refractory urothelial carcinomaImproved progression-free survivalPre-specified subgroup analysisCox proportional hazards modelMetastatic UC patientsMetastatic urothelial carcinomaAdvanced urothelial carcinomaKaplan-Meier methodSubgroup of patientsProportional hazards modelICI therapyUC patientsDocetaxel armMost patientsAdverse eventsARM patients
2019
921P Quality of life of metastatic urothelial cancer (mUC) patients treated with enfortumab vedotin (EV) following platinum-containing chemotherapy and a checkpoint inhibitor (CPI): Data from EV-201 cohort 1
McGregor B, O’Donnell P, Balar A, Petrylak D, Rosenberg J, Yu E, Quinn D, Shah S, Pinelli J, Hepp Z, Galsky M. 921P Quality of life of metastatic urothelial cancer (mUC) patients treated with enfortumab vedotin (EV) following platinum-containing chemotherapy and a checkpoint inhibitor (CPI): Data from EV-201 cohort 1. Annals Of Oncology 2019, 30: v367-v368. DOI: 10.1093/annonc/mdz249.020.Peer-Reviewed Original ResearchBristol-Myers SquibbGenentech/RochePlatinum-containing chemotherapyEnfortumab vedotinVisual analog scaleCheckpoint inhibitorsCohort 1EMD SeronoSeattle GeneticsAstellas Pharma Inc.Metastatic urothelial cancer patientsPatient-reported outcome measuresSelf-rated health statusPain/discomfortUrothelial cancer patientsGreater symptom burdenAnxiety/depressionEQ-5D utilitiesMUC patientsPrior chemotherapyExploratory endpointsSymptom burdenVAS scoresCancer QualityCycle 5LBA55 Initial results from TROPHY-U-01: A phase II open-label study of sacituzumab govitecan in patients (Pts) with metastatic urothelial cancer (mUC) after failure of platinum-based regimens (PLT) or immunotherapy
Tagawa S, Balar A, Petrylak D, Grivas P, Agarwal N, Sternberg C, Hong Q, Gladden A, Kanwal C, Siemon-Hryczyk P, Goswami T, Itri L, Loriot Y. LBA55 Initial results from TROPHY-U-01: A phase II open-label study of sacituzumab govitecan in patients (Pts) with metastatic urothelial cancer (mUC) after failure of platinum-based regimens (PLT) or immunotherapy. Annals Of Oncology 2019, 30: v890-v891. DOI: 10.1093/annonc/mdz394.049.Peer-Reviewed Original ResearchMetastatic urothelial cancerPlatinum-based regimensBristol-Myers SquibbSacituzumab govitecanCheckpoint inhibitorsTrial conductionScientific Advisory BoardSeattle GeneticsBavarian NordicEMD SeronoCohort 1Phase II open-label studyPhase I/II studyECOG performance status 0Boehringer IngelheimPre-planned interim analysisHigh unmet medical needClovis OncologyTreatment-related AEsAntitumor activityOpen-label studyPerformance status 0Significant clinical activitySingle-agent chemotherapyTreatment-related deathsEV-201: Results of enfortumab vedotin monotherapy for locally advanced or metastatic urothelial cancer previously treated with platinum and immune checkpoint inhibitors.
Petrylak D, Balar A, O'Donnell P, McGregor B, Heath E, Yu E, Galsky M, Hahn N, Gartner E, Pinelli J, Melhem-Bertrandt A, Rosenberg J. EV-201: Results of enfortumab vedotin monotherapy for locally advanced or metastatic urothelial cancer previously treated with platinum and immune checkpoint inhibitors. Journal Of Clinical Oncology 2019, 37: 4505-4505. DOI: 10.1200/jco.2019.37.18_suppl.lba4505.Peer-Reviewed Original ResearchTreatment-related AEsMetastatic urothelial cancerCheckpoint inhibitorsDuration of responseLiver metastasesUrothelial cancerCohort 1Common treatment-related AEsBlinded independent central reviewImmune checkpoint inhibitorsManageable safety profilePlatinum-containing chemotherapyPhase 1 trialLimited treatment optionsIndependent central reviewHigh unmet needTwo-cohort studyMUC patientsPrior chemotherapyPrior platinumRECIST 1.1Primary endpointSecondary endpointsPulmonary infectionPeripheral neuropathyEV-103: Enfortumab vedotin plus pembrolizumab and/or chemotherapy for locally advanced or metastatic urothelial cancer.
Hoimes C, Rosenberg J, Petrylak D, Carret A, Melhem-Bertrandt A, Flaig T. EV-103: Enfortumab vedotin plus pembrolizumab and/or chemotherapy for locally advanced or metastatic urothelial cancer. Journal Of Clinical Oncology 2019, 37: tps4593-tps4593. DOI: 10.1200/jco.2019.37.15_suppl.tps4593.Peer-Reviewed Original ResearchMetastatic urothelial cancerCheckpoint inhibitorsDay 1Urothelial cancerCombination therapyMicrotubule-disrupting agent monomethyl auristatin EInvestigational antibody-drug conjugateFirst-line cisplatinPlatinum-containing regimenDisease control rateImmune checkpoint inhibitorsPhase 1b trialPhase 1 studyDuration of responseEnhanced immune responseMonomethyl auristatin EAntibody-drug conjugatesDose expansionResponse durabilityControl rateDisease progressionImmune responseAuristatin EResponse rateNectin-4Treatment 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