2024
Sacituzumab 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 expressionA 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 EORREfficacy of Antibody Drug Conjugates Alone and in Combination with other Agents in Metastatic Urothelial Carcinoma: A Scoping Review
Grant M, Stockhammer P, Austin M, Nemeth Z, Petrylak D. Efficacy of Antibody Drug Conjugates Alone and in Combination with other Agents in Metastatic Urothelial Carcinoma: A Scoping Review. Bladder Cancer 2024, 10: 9-23. PMID: 38993528, PMCID: PMC11181835, DOI: 10.3233/blc-230070.Peer-Reviewed Original ResearchMetastatic urothelial carcinomaAntibody-drug conjugatesClinical trialsUrothelial carcinomaCombination regimensDrug conjugatesSystematic reviewAnti-PD-1 agentsProspective therapeutic clinical trialsCochrane Central TrialsClinical trial cohortObjective response rateTherapeutic clinical trialsMeta-Analyses (PRISMA) statementNon-duplicated articlesPreferred Reporting ItemsComprehensive systematic reviewPotent cytotoxic payloadTrial cohortEnfortumab vedotinOvid EmbaseSacituzumab govitecanADC targetImpressive efficacyOvid MEDLINESacituzumab 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
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 eventsEfficacy 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 endpointPrimary analysis of TROPHY-U-01 cohort 3, a phase 2 study of sacituzumab govitecan (SG) in combination with pembrolizumab (Pembro) in patients (pts) with metastatic urothelial cancer (mUC) that progressed after platinum (PT)-based therapy.
Grivas P, Pouessel D, Park C, Barthelemy P, Bupathi M, Petrylak D, Agarwal N, Gupta S, Flechon A, Ramamurthy C, Davis N, Recio-Boiles A, Sternberg C, Bhatia A, Pichardo C, Sierecki M, Tonelli J, Zhou H, Tagawa S, Loriot Y. Primary analysis of TROPHY-U-01 cohort 3, a phase 2 study of sacituzumab govitecan (SG) in combination with pembrolizumab (Pembro) in patients (pts) with metastatic urothelial cancer (mUC) that progressed after platinum (PT)-based therapy. Journal Of Clinical Oncology 2023, 41: 518-518. DOI: 10.1200/jco.2023.41.6_suppl.518.Peer-Reviewed Original ResearchTreatment-related adverse eventsObjective response rateMetastatic urothelial cancerProgression-free survivalDuration of responseHigher objective response rateSacituzumab govitecanCentral reviewCohort 3Primary analysisAnti-Trop-2 antibodyMedian DORMedian progression-free survivalAccelerated FDA approvalClinical benefit rateECOG PS 0ECOG PS 1Manageable safety profileTreatment-related deathsNew safety signalsPhase 2 studyG-CSF useAnti-cancer therapyMedian OSSystemic steroidsPrimary analysis of TROPHY-U-01 cohort 2, a phase 2 study of sacituzumab govitecan (SG) in platinum (PT)-ineligible patients (pts) with metastatic urothelial cancer (mUC) that progressed after prior checkpoint inhibitor (CPI) therapy.
Petrylak D, Tagawa S, Jain R, Bupathi M, Balar A, Rezazadeh 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. Primary analysis of TROPHY-U-01 cohort 2, a phase 2 study of sacituzumab govitecan (SG) in platinum (PT)-ineligible patients (pts) with metastatic urothelial cancer (mUC) that progressed after prior checkpoint inhibitor (CPI) therapy. Journal Of Clinical Oncology 2023, 41: 520-520. DOI: 10.1200/jco.2023.41.6_suppl.520.Peer-Reviewed Original ResearchTreatment-related adverse eventsMetastatic urothelial cancerObjective response rateProgression-free survivalDuration of responseManageable safety profilePrior anticancer therapyMedian overall survivalCPI therapySacituzumab govitecanOverall survivalCentral reviewMedian timeSafety profileTreatment optionsCohort 2Primary analysisResponse rateAnti-Trop-2 antibodyMedian DORMedian progression-free survivalAccelerated FDA approvalCheckpoint inhibitor therapyECOG PS 0ECOG PS 1Updated 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
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.
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 signalsTROPHY-U-01 cohort 4: Sacituzumab govitecan (SG) in combination with cisplatin (Cis) in platinum (PLT)-naïve patients (pts) with metastatic urothelial cancer (mUC).
Tagawa S, Grivas P, Petrylak D, Sternberg C, Swami U, Bhatia A, Pichardo C, Goswami T, Loriot Y. TROPHY-U-01 cohort 4: Sacituzumab govitecan (SG) in combination with cisplatin (Cis) in platinum (PLT)-naïve patients (pts) with metastatic urothelial cancer (mUC). Journal Of Clinical Oncology 2022, 40: tps581-tps581. DOI: 10.1200/jco.2022.40.6_suppl.tps581.Peer-Reviewed Original ResearchMetastatic urothelial cancerBlinded independent central reviewObjective response rateSacituzumab govitecanOverall survivalDay 1Antibody-drug conjugatesCohort 4Eastern Cooperative Oncology Group performance status 0Prophylactic granulocyte colony-stimulating factorActive interstitial lung diseaseAntigen 2 antibodiesClinical benefit ratePerformance status 0Phase 2 doseStudy drug initiationMedian overall survivalProgression-free survivalPhase 2 trialDose-limiting toxicityInterstitial lung diseaseDuration of responseEfficacy/safetyGranulocyte colony-stimulating factorIndependent central review
2021
700P Efficacy of sacituzumab govitecan (SG) by trophoblast cell surface antigen 2 (Trop-2) expression in patients (Pts) with metastatic urothelial cancer (mUC)
Loriot Y, Balar A, Petrylak D, Rezazadeh A, Grivas P, Fléchon A, Jain R, Agarwal N, Bupathi M, Barthelemy P, Beuzeboc P, Palmbos P, Kyriakopoulos C, Pouessel D, Sternberg C, Pan Y, Jürgensmeier J, Goswami T, Tagawa S. 700P Efficacy of sacituzumab govitecan (SG) by trophoblast cell surface antigen 2 (Trop-2) expression in patients (Pts) with metastatic urothelial cancer (mUC). Annals Of Oncology 2021, 32: s712-s713. DOI: 10.1016/j.annonc.2021.08.096.Peer-Reviewed Original Research
2020
TROPHY-U-01 Cohort 3: Sacituzumab govitecan (SG) and pembrolizumab (pembro) in patients (pts) with progression or recurrence of metastatic urothelial cancer (mUC) after platinum (PLT)-based therapy
Grivas P, Sternberg C, Agarwal N, Petrylak D, Tagawa S, Hong Q, Gladden A, Kanwal C, Goswami T, Loriot Y. TROPHY-U-01 Cohort 3: Sacituzumab govitecan (SG) and pembrolizumab (pembro) in patients (pts) with progression or recurrence of metastatic urothelial cancer (mUC) after platinum (PLT)-based therapy. Annals Of Oncology 2020, 31: s604-s605. DOI: 10.1016/j.annonc.2020.08.2067.Peer-Reviewed Original ResearchTROPHY-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 ResearchEarly results of TROPHY-U-01 Cohort 2: Sacituzumab govitecan (SG) in platinum-ineligible patients (pts) with metastatic urothelial cancer (mUC) who progressed after prior checkpoint inhibitor (CPI) therapy.
Petrylak D, Tagawa S, Jain R, Bupathi M, Balar A, Rezazadeh A, George S, Palmbos P, Nordquist L, Davis N, Vogelzang N, Ramamurthy C, Sternberg C, Loriot Y, Agarwal N, Hong Q, Gladden A, Kanwal C, Goswami T, Grivas P. Early results of TROPHY-U-01 Cohort 2: Sacituzumab govitecan (SG) in platinum-ineligible patients (pts) with metastatic urothelial cancer (mUC) who progressed after prior checkpoint inhibitor (CPI) therapy. Journal Of Clinical Oncology 2020, 38: 5027-5027. DOI: 10.1200/jco.2020.38.15_suppl.5027.Peer-Reviewed Original ResearchMetastatic urothelial cancerOverall response rateTreatment-related AEsSacituzumab govitecanCPI therapySafety profileCohort 2Anti-Trop-2 antibodyFirst-line metastatic settingECOG PS 0Epithelial cell surface antigenPlatinum-ineligible patientsPrior treatment linesTreatment-related deathsCheckpoint inhibitor therapyManageable safety profilePhase 2 trialProgression-free survivalInterstitial lung diseaseDuration of responseMajority of ptsCell surface antigensAdvanced UCCPI treatmentFebrile neutropenia
2019
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
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 deathsTROPHY-U-01: A phase II open-label study of sacituzumab govitecan (IMMU-132) in patients with advanced urothelial cancer after progression on platinum-based chemotherapy and/or anti-PD-1/PD-L1 checkpoint inhibitor therapy.
Tagawa S, Petrylak D, Grivas P, Agarwal N, Sternberg C, Hernandez C, Siemon-Hryczyk P, Goswami T, Loriot Y. TROPHY-U-01: A phase II open-label study of sacituzumab govitecan (IMMU-132) in patients with advanced urothelial cancer after progression on platinum-based chemotherapy and/or anti-PD-1/PD-L1 checkpoint inhibitor therapy. Journal Of Clinical Oncology 2019, 37: tps3153-tps3153. DOI: 10.1200/jco.2019.37.15_suppl.tps3153.Peer-Reviewed Original ResearchObjective response rateAdvanced urothelial cancerProgression-free survivalCheckpoint inhibitor therapyPhase 2 trialSacituzumab govitecanUrothelial cancerEvaluable ptsAdverse eventsInhibitor therapyEastern Cooperative Oncology Group performance status scorePhase II open-label studyTrop-2Median progression-free survivalNeutropenia/neutrophil countEpithelial cell surface antigenOpen-label studyPerformance status scorePhase 1/2 trialPlatinum-based chemotherapyActive metabolite SN38Cell surface antigensFebrile neutropeniaMeasurable diseasePivotal cohortSacituzumab govitecan (IMMU-132) in patients with previously treated metastatic urothelial cancer (mUC): Results from a phase I/II study.
Tagawa S, Faltas B, Lam E, Saylor P, Bardia A, Hajdenberg J, Morgans A, Lim E, Kalinsky K, Simpson P, Galsky M, Goswam T, Wegener W, Petrylak D. Sacituzumab govitecan (IMMU-132) in patients with previously treated metastatic urothelial cancer (mUC): Results from a phase I/II study. Journal Of Clinical Oncology 2019, 37: 354-354. DOI: 10.1200/jco.2019.37.7_suppl.354.Peer-Reviewed Original ResearchMetastatic urothelial cancerObjective response rateProgression-free survivalDuration of responseSacituzumab govitecanOverall survivalPhase I/II studyImmune checkpoint inhibitor therapyMedian DORMedian progression-free survivalNeutropenia/neutrophil countNovel antibody-drug conjugateClinical benefit rateEpithelial cell surface antigenPrior treatment linesCheckpoint inhibitor therapyAdvanced solid tumorsCT/MRI scansPhase 2 trialLimited treatment optionsCell surface antigensAntibody-drug conjugatesAdvanced UCFebrile neutropeniaRECIST 1.1TROPHY-u-01: A phase II open-label study of sacituzumab govitecan (IMMU-132) in patients with advanced urothelial cancer after progression on platinum-based chemotherapy and/or anti-PD-1/PD-L1 checkpoint inhibitor therapy.
Tagawa S, Petrylak D, Grivas P, Agarwal N, Sternberg C, Siemon-Hryczyk P, Goswam T, Loriot Y. TROPHY-u-01: A phase II open-label study of sacituzumab govitecan (IMMU-132) in patients with advanced urothelial cancer after progression on platinum-based chemotherapy and/or anti-PD-1/PD-L1 checkpoint inhibitor therapy. Journal Of Clinical Oncology 2019, 37: tps495-tps495. DOI: 10.1200/jco.2019.37.7_suppl.tps495.Peer-Reviewed Original ResearchObjective response rateMetastatic urothelial cancerPlatinum-based chemotherapyCheckpoint inhibitor therapyPhase 2 trialSacituzumab govitecanAdverse eventsInhibitor therapyUrothelial cancerPhase II open-label studyTrop-2Median progression-free survivalAdvanced urothelial cancerEpithelial cell surface antigenMedian overall survivalOpen-label studySafety/tolerabilityProgression-free survivalSingle-arm trialCell surface antigensAdvanced UCEvaluable ptsPrior therapyRECIST 1.1Overall survival