2025
Avelumab 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 ResearchMeSH KeywordsAge FactorsAgedAged, 80 and overAntibodies, Monoclonal, HumanizedAntineoplastic Agents, ImmunologicalCarcinoma, Transitional CellFemaleHumansMaleMiddle AgedTreatment OutcomeUrinary Bladder NeoplasmsConceptsProgression-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 carePatients
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 studySacituzumab Govitecan Demonstrates Efficacy across Tumor Trop-2 Expression Levels in Patients with Advanced Urothelial Cancer.
Loriot Y, Balar A, Petrylak D, Kalebasty A, Grivas P, Fléchon A, Jain R, Swami U, Bupathi M, Barthélémy P, Beuzeboc P, Palmbos P, Kyriakopoulos C, Pouessel D, Sternberg C, Tonelli J, Sierecki M, Zavodovskaya M, Elboudwarej E, Diehl L, Jürgensmeier J, Tagawa S. Sacituzumab Govitecan Demonstrates Efficacy across Tumor Trop-2 Expression Levels in Patients with Advanced Urothelial Cancer. Clinical Cancer Research 2024, 30: 3179-3188. PMID: 39086310, DOI: 10.1158/1078-0432.ccr-23-3924.Peer-Reviewed Original ResearchConceptsTrop-2 expressionTrop-2Positive tumor cellsUrothelial cancerMetastatic UCSacituzumab govitecanTumor cellsTumor samplesOpen-label phase II studyTrophoblast cell surface antigen 2Human trophoblast cell-surface antigen 2Advanced urothelial cancerSN-38 payloadPhase II studyC1-3Archival tumor samplesExpression levelsCohorts 1 to 3Surface antigen 2Antibody drug conjugatesOS benefitII studyExamined tumorsH-scoreMembrane expression
2023
Enfortumab Vedotin With or Without Pembrolizumab in Cisplatin-Ineligible Patients With Previously Untreated Locally Advanced or Metastatic Urothelial Cancer
O'Donnell P, Milowsky M, Petrylak D, Hoimes C, Flaig T, Mar N, Moon H, Friedlander T, McKay R, Bilen M, Srinivas S, Burgess E, Ramamurthy C, George S, Geynisman D, Bracarda S, Borchiellini D, Geoffrois L, Rey J, Ferrario C, Carret A, Yu Y, Guseva M, Moreno B, Rosenberg J. Enfortumab Vedotin With or Without Pembrolizumab in Cisplatin-Ineligible Patients With Previously Untreated Locally Advanced or Metastatic Urothelial Cancer. Journal Of Clinical Oncology 2023, 41: 4107-4117. PMID: 37369081, PMCID: PMC10852367, DOI: 10.1200/jco.22.02887.Peer-Reviewed Original ResearchConceptsTreatment-related adverse eventsCisplatin-ineligible patientsDuration of responseMetastatic urothelial cancerUrothelial cancerAdverse eventsHigher treatment-related adverse eventsPhase Ib/II studyMedian DORFirst-line treatment optionEnd pointBlinded independent central reviewCommon grade 3Objective response ratePrimary end pointSecondary end pointsNew safety signalsCisplatin-based therapyIndependent central reviewUntreated LACombination armDurable responsesII studyMaculopapular rashSurvival benefit
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