2025
Study EV-103 cohort H: Neoadjuvant treatment with enfortumab vedotin (EV) monotherapy in cisplatin (cis)-ineligible patients (pts) with muscle invasive bladder cancer (MIBC)—3-year efficacy results.
Mar N, Petrylak D, Hoimes C, Rosenberg J, Flaig T, Gourdin T, Barata P, Henry E, Bilen M, George S, Rao S, Assikis V, Burgess E, Lewis B, Srinivas S, Gorla S, Meng C, Zhu Y, O'Donnell P. Study EV-103 cohort H: Neoadjuvant treatment with enfortumab vedotin (EV) monotherapy in cisplatin (cis)-ineligible patients (pts) with muscle invasive bladder cancer (MIBC)—3-year efficacy results. Journal Of Clinical Oncology 2025, 43: 4583-4583. DOI: 10.1200/jco.2025.43.16_suppl.4583.Peer-Reviewed Original ResearchMedian event-free survivalPathological complete responseEvent-free survivalInvestigator assessmentEnfortumab vedotinEfficacy resultsOS ratesNeoadjuvant treatmentSafety profileFollow-upPathologic complete response ratePelvic lymph node dissectionEvent-free survival rateAntitumor activityLong-term follow-upCentral pathology reviewEstimated OS ratesNeoadjuvant treatment optionsLymph node dissectionMedian follow-upPhase 3 trialCT2-T4aN0M0Median OSConsistent with prior reportsComplete responseARCHES: 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 volumeAvelumab 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 endpoint
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 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 endpointAvelumab 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 study
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