2025
ARCHES: 5-year follow-up overall survival (OS) analysis of enzalutamide (ENZA) plus androgen-deprivation therapy (ADT) in patients (pts) with metastatic hormone-sensitive prostate cancer (mHSPC).
Armstrong A, Petrylak D, Shore N, Szmulewitz R, Holzbeierlein J, Villers A, Alcaraz A, Alekseev B, Iguchi T, Gomez-Veiga F, Croitoru R, Wu R, Kalac M, Tang Y, Stenzl A, Azad A. ARCHES: 5-year follow-up overall survival (OS) analysis of enzalutamide (ENZA) plus androgen-deprivation therapy (ADT) in patients (pts) with metastatic hormone-sensitive prostate cancer (mHSPC). Journal Of Clinical Oncology 2025, 43: 5005-5005. DOI: 10.1200/jco.2025.43.16_suppl.5005.Peer-Reviewed Original ResearchMetastatic hormone-sensitive prostate cancerAndrogen deprivation therapyOverall survivalOS analysisRadiographic progression-free survivalHormone-sensitive prostate cancerLong-term follow-upGlobal phase 3Low-volume patientsOpen-label enzalutamideProgression-free survivalEfficacy of enzalutamideMedian follow-upOpen-label extensionKaplan-Meier methodLong-term efficacyStandard-of-careClinically relevant subgroupsCox regression modelsFollow-up dataARCH trialDocetaxel useMedian OSAndrogen deprivationDisease volumeEnzalutamide and Prostate-Specific Antigen Levels in Metastatic Prostate Cancer
Azad A, Petrylak D, Iguchi T, Shore N, Villers A, Gomez-Veiga F, Alcaraz A, Alekseev B, Szmulewitz R, Holzbeierlein J, Rosbrook B, Ma J, Zohren F, El-Chaar N, Haas G, Stenzl A, Armstrong A. Enzalutamide and Prostate-Specific Antigen Levels in Metastatic Prostate Cancer. JAMA Network Open 2025, 8: e258751. PMID: 40332939, PMCID: PMC12059972, DOI: 10.1001/jamanetworkopen.2025.8751.Peer-Reviewed Original ResearchConceptsMetastatic hormone-sensitive prostate cancerProstate-specific antigen levelRadiographic progression-free survivalUndetectable prostate-specific antigenAndrogen deprivation therapyProstate-specific antigenProstate-specific antigen declineClinical outcomesOverall survivalProstate cancerClinical trialsHazard ratioPatients treated with enzalutamideHormone-sensitive prostate cancerPhase 3 randomized clinical trialAssociated with improved survivalStudy enrollmentProgression-free survivalMetastatic prostate cancerRadiographic disease progressionClinical end pointsPost hoc secondary analysisRandomized clinical trialsReduced riskSecondary analysisAvelumab first-line maintenance for advanced urothelial carcinoma: long-term outcomes from the JAVELIN Bladder 100 trial in older patients ☆
Gupta S, Duran M, Sridhar S, Powles T, Bellmunt J, Park S, Gurney H, Tsuchiya N, Petrylak D, Tomita Y, di Pietro A, Manitz J, Tyroller K, Hoffman J, Jacob N, Grivas P. Avelumab first-line maintenance for advanced urothelial carcinoma: long-term outcomes from the JAVELIN Bladder 100 trial in older patients ☆. ESMO Open 2025, 10: 104506. PMID: 40107155, PMCID: PMC11964637, DOI: 10.1016/j.esmoop.2025.104506.Peer-Reviewed Original ResearchConceptsProgression-free survivalPlatinum-based chemotherapyOverall survivalUrothelial carcinomaProgression-free survival analysisOlder ageAdvanced urothelial carcinomaFirst-line maintenanceMetastatic urothelial carcinomaProlonged overall survivalPhase III trialsKaplan-Meier methodQuality-adjusted timeLong-term outcomesJAVELIN BladderMedian OSIII trialsFirst-linePrimary endpointAvelumabBladder cancerOlder patientsAge subgroupsSupportive carePatientsPembrolizumab Plus Docetaxel Versus Docetaxel for Previously Treated Metastatic Castration-Resistant Prostate Cancer: The Randomized, Double-Blind, Phase III KEYNOTE-921 Trial
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, Retz M, Levesque E, McDermott R, Bracarda S, Manneh R, Levartovsky M, Li X, Schloss C, Poehlein C, Fizazi K. Pembrolizumab Plus Docetaxel Versus Docetaxel for Previously Treated Metastatic Castration-Resistant Prostate Cancer: The Randomized, Double-Blind, Phase III KEYNOTE-921 Trial. Journal Of Clinical Oncology 2025, 43: 1638-1649. PMID: 40043230, PMCID: PMC12058370, DOI: 10.1200/jco-24-01283.Peer-Reviewed Original ResearchMetastatic castration-resistant prostate cancerTreat metastatic castration-resistant prostate cancerRadiographic progression-free survivalAndrogen receptor pathway inhibitorsCastration-resistant prostate cancerTreatment-related adverse eventsStandard of careAdverse eventsOverall survivalDouble-blindProstate cancerMedian radiographic progression-free survivalDual primary end pointsImmune-mediated adverse eventsEnd pointsBlinded independent central reviewData cutoff dateSafety of pembrolizumabAndrogen deprivation therapyProgression-free survivalIndependent central reviewSecondary end pointsPrimary end pointConcomitant prednisoneMedian OSAvelumab first-line maintenance (1LM) in patients (pts) with advanced urothelial carcinoma (aUC) with or without diabetes mellitus (DM): Long-term outcomes from JAVELIN Bladder 100.
Gupta S, Grivas P, Park S, Petrylak D, Tyroller K, Hoffman J, Bellmunt J. Avelumab first-line maintenance (1LM) in patients (pts) with advanced urothelial carcinoma (aUC) with or without diabetes mellitus (DM): Long-term outcomes from JAVELIN Bladder 100. Journal Of Clinical Oncology 2025, 43: 869-869. DOI: 10.1200/jco.2025.43.5_suppl.869.Peer-Reviewed Original ResearchProgression-free survivalAdvanced urothelial carcinomaBest supportive carePlatinum-based chemotherapyOverall survivalDiabetes mellitusAdverse eventsAssociated with long-term efficacyImmune-related adverse eventsTreatment-related adverse eventsFirst-line maintenanceAssociated with reduced efficacyEfficacy of immunotherapyMedian follow-upProlonged overall survivalLong-term efficacyPresence of DMLong-term outcomesPost hoc exploratory analysisJAVELIN BladderMedian OSMetastatic UCUrothelial carcinomaEligible ptsPrimary endpointA phase III randomized trial of eribulin (E) with gemcitabine 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, Callis S, Lara P, Berg S, Brown J, Bangs R, Nakagawa D, Daneshmand S, Ian Murchie Jr., Flaig T, Petrylak D, Lerner S. A phase III randomized trial of eribulin (E) with gemcitabine 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 2025, 43: tps887-tps887. DOI: 10.1200/jco.2025.43.5_suppl.tps887.Peer-Reviewed Original ResearchMetastatic urothelial carcinomaProgression-free survivalStandard of careEnfortumab vedotinOverall survivalCisplatin-ineligible metastatic urothelial carcinomaMedian progression-free survivalPhase III randomized trialStudies of eribulinMedian overall survivalPlatinum-based chemotherapyLines of therapyEndpoint of OSOne-sided alphaFGFR3 alterationsLiver metastasesSystemic therapyEligible ptsUrothelial carcinomaPrimary endpointSecondary endpointsGenitourinary cancersEribulinTreatment changesGemcitabine
2024
TROPHY-U-01 Cohort 2: A Phase II Study of Sacituzumab Govitecan in Cisplatin-Ineligible Patients With Metastatic Urothelial Cancer Progressing After Previous Checkpoint Inhibitor Therapy
Petrylak D, Tagawa S, Jain R, Bupathi M, Balar A, Kalebasty A, George S, Palmbos P, Nordquist L, Davis N, Ramamurthy C, Sternberg C, Loriot Y, Agarwal N, Park C, Tonelli J, Vance M, Zhou H, Grivas P, Petrylak D, Tagawa S, Jain R, Bupathi M, Balar A, Kalebasty A, George S, Palmbos P, Nordquist L, Davis N, Ramamurthy C, Sternberg C, Agarwal N, Park C, Tonelli J, Vance M, Zhou H, Grivas P, Loriot Y. TROPHY-U-01 Cohort 2: A Phase II Study of Sacituzumab Govitecan in Cisplatin-Ineligible Patients With Metastatic Urothelial Cancer Progressing After Previous Checkpoint Inhibitor Therapy. Journal Of Clinical Oncology 2024, 42: 3410-3420. PMID: 39186707, PMCID: PMC11458109, DOI: 10.1200/jco.23.01720.Peer-Reviewed Original ResearchConceptsMetastatic urothelial cancerClinical benefit rateProgression-free survivalDuration of responseCisplatin-ineligible patientsCheckpoint inhibitor therapyPhase II studyCheckpoint inhibitorsSacituzumab govitecanCohort 2Central reviewOpen-label phase II studyPlatinum (Pt)-based chemotherapyMedian duration of responseMedian progression-free survivalTreatment-emergent adverse eventsMedian overall survivalSN-38 payloadUrothelial cancer progressionSecondary end pointsAntibody-drug conjugatesCisplatin-ineligibleInhibitor therapyOverall survivalII studyPatient-reported outcomes (PROs) from a randomized, phase 3 trial of enfortumab vedotin plus pembrolizumab (EV+P) versus platinum-based chemotherapy (PBC) in previously untreated locally advanced or metastatic urothelial cancer (la/mUC).
Kikuchi E, Gupta S, Loriot Y, Van Der Heijden M, Bedke J, Valderrama B, Flechon A, Petrylak D, De Santis M, Galsky M, Lee J, Swami U, Sridhar S, De Giorgi U, Wright P, Lu Y, Guan X, Dillon R, Homet Moreno B, Powles T. Patient-reported outcomes (PROs) from a randomized, phase 3 trial of enfortumab vedotin plus pembrolizumab (EV+P) versus platinum-based chemotherapy (PBC) in previously untreated locally advanced or metastatic urothelial cancer (la/mUC). Journal Of Clinical Oncology 2024, 42: 108-108. DOI: 10.1200/jco.2024.42.23_suppl.108.Peer-Reviewed Original ResearchTime to pain progressionPlatinum-based chemotherapyPatient-reported outcomesBPI-SFPatients treated with platinum-based chemotherapyMedian time to pain progressionBrief Pain Inventory Short FormMetastatic urothelial cancerProgression-free survivalKaplan-Meier methodPhase 3 trialSurvival follow-upPatient-reported outcome assessmentsEnfortumab vedotinOverall survivalPain progressionTransient worseningUrothelial cancerPost-progressionQuality of Life QuestionnaireSevere painImproved survivalWorst painFollow-upWeek 4Patient-reported outcomes (PROs) from a randomized, phase 3 trial of enfortumab vedotin plus pembrolizumab (EV+P) versus platinum-based chemotherapy (PBC) in previously untreated locally advanced or metastatic urothelial cancer (la/mUC).
Gupta S, Loriot Y, Van Der Heijden M, Bedke J, Valderrama B, Kikuchi E, Flechon A, Petrylak D, De Santis M, Galsky M, Lee J, Swami U, Sridhar S, De Giorgi U, Wright P, Lu Y, Guan X, Dillon R, Homet Moreno B, Powles T. Patient-reported outcomes (PROs) from a randomized, phase 3 trial of enfortumab vedotin plus pembrolizumab (EV+P) versus platinum-based chemotherapy (PBC) in previously untreated locally advanced or metastatic urothelial cancer (la/mUC). Journal Of Clinical Oncology 2024, 42: 4502-4502. DOI: 10.1200/jco.2024.42.16_suppl.4502.Peer-Reviewed Original ResearchTime to pain progressionPlatinum-based chemotherapyPatient-reported outcomesBPI-SFMedian time to pain progressionPatients treated with platinum-based chemotherapyBrief Pain Inventory Short FormMetastatic urothelial cancerProgression-free survivalKaplan-Meier methodPhase 3 trialSurvival follow-upPatient-reported outcome assessmentsEnfortumab vedotinOverall survivalPain progressionTransient worseningUrothelial cancerQuality of Life QuestionnairePost-progressionSevere painImproved survivalWorst painFollow-upGlobal health status/qualityAvelumab 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 UCAvelumab 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 endpointA phase 2/3 study of Bicycle toxin conjugate BT8009 targeting nectin-4 in patients with locally advanced or metastatic urothelial cancer (la/mUC): Duravelo-2.
Loriot Y, Siefker-Radtke A, Friedlander T, Necchi A, Wei A, Sridhar S, Garmezy B, Arroyo S, Gartside E, Liu J, Campbell C, Bader J, Petrylak D. A phase 2/3 study of Bicycle toxin conjugate BT8009 targeting nectin-4 in patients with locally advanced or metastatic urothelial cancer (la/mUC): Duravelo-2. Journal Of Clinical Oncology 2024, 42: tps4619-tps4619. DOI: 10.1200/jco.2024.42.16_suppl.tps4619.Peer-Reviewed Original ResearchUrothelial cancerMonomethyl auristatin ECohort 2Cohort 1Nectin-4Optimal doseExposure to normal tissuesInterim analysisBlinded independent central reviewMetastatic urothelial cancerObjective response ratePenetrate solid tumorsAdequate organ functionDisease control rateProgression-free survivalPlatinum-based chemotherapyDuration of responseECOG performance statusPreliminary antitumor activityIndependent central reviewPlasma half-lifeWeeks follow-upMetastatic UCRECIST v1.1Enfortumab vedotinAvelumab first-line (1L) maintenance for advanced urothelial carcinoma (aUC): Long-term outcomes from the JAVELIN Bladder 100 trial in patients (pts) with high body mass index (BMI).
Aragon-Ching J, Petrylak D, Sridhar S, Gupta S, Grivas P, Powles T, Gurney H, Jacob N, Tyroller K, Guenther S, 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 high body mass index (BMI). Journal Of Clinical Oncology 2024, 42: 600-600. DOI: 10.1200/jco.2024.42.4_suppl.600.Peer-Reviewed Original ResearchProgression-free survivalAdvanced urothelial carcinomaPlatinum-based chemotherapyBody mass indexHigher body mass indexLong-term outcomesOverall survivalLong-term safetyStandard of careMedian progression-free survivalProgression-free survival ratesAnalysis of long-term outcomesBSC-alone armMedian follow-upProlonged overall survivalLevel 1 evidenceLong-term efficacyInternational treatment guidelinesPost hoc analysisJAVELIN BladderMedian OSMetastatic UCOS ratesSafety populationData cutoffSacituzumab 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
1803P Phase I/II study of bavdegalutamide, a PROTAC androgen receptor (AR) degrader in metastatic castration-resistant prostate cancer (mCRPC): Radiographic progression-free survival (rPFS) in patients (pts) with AR ligand-binding domain (LBD) mutations
Petrylak D, Garmezy B, Shen J, Kalebasty A, Sartor O, Dreicer R, Agarwal N, Hussain M, Percent I, Heath E, Gedrich R, Yu T, Healey D, Parameswaran J, Sternberg C, Gao X. 1803P Phase I/II study of bavdegalutamide, a PROTAC androgen receptor (AR) degrader in metastatic castration-resistant prostate cancer (mCRPC): Radiographic progression-free survival (rPFS) in patients (pts) with AR ligand-binding domain (LBD) mutations. Annals Of Oncology 2023, 34: s973-s974. DOI: 10.1016/j.annonc.2023.09.2751.Peer-Reviewed Original ResearchAvelumab First-line Maintenance for Advanced Urothelial Carcinoma: Analysis from JAVELIN Bladder 100 by Duration of First-line Chemotherapy and Interval Before Maintenance
Sridhar S, Powles T, Climent Durán M, Park S, Massari F, Thiery-Vuillemin A, Valderrama B, Ullén A, Tsuchiya N, Aragon-Ching J, Gupta S, Petrylak D, Bellmunt J, Wang J, Laliberte R, di Pietro A, Costa N, Grivas P, Sternberg C, Loriot Y. Avelumab First-line Maintenance for Advanced Urothelial Carcinoma: Analysis from JAVELIN Bladder 100 by Duration of First-line Chemotherapy and Interval Before Maintenance. European Urology 2023, 85: 154-163. PMID: 37714742, DOI: 10.1016/j.eururo.2023.08.001.Peer-Reviewed Original ResearchBest supportive careProgression-free survivalAdvanced urothelial carcinomaFirst-line chemotherapyPlatinum-based chemotherapyOverall survivalFirst-line maintenanceChemotherapy durationMaintenance treatmentUrothelial carcinomaFirst-line platinum-based chemotherapyAnalysis of OSAdvanced urothelial cancerPhase 3 trialAnalysis of subgroupsAdvanced UCPrior chemotherapyProspective trialSafety findingsSupportive careHazard ratioUrothelial cancerDisease progressionChemotherapyOverall populationEV-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 cancersEnfortumab 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 endpoint
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