2024
Trastuzumab Deruxtecan With Nivolumab in HER2-Expressing Metastatic Breast or Urothelial Cancer: Analysis of the Phase Ib DS8201-A-U105 Study
Hamilton E, Galsky M, Ochsenreither S, Del Conte G, Martín M, de Miguel M, Yu E, Williams A, Gion M, Tan A, Agrawal L, Rutten A, Machiels J, Cresta S, Debruyne P, Hennequin A, Moreno V, Minchom A, Valdes-Albini F, Petrylak D, Li L, Tsuchihashi Z, Suto F, Cheng F, Kandil M, Barrios D, Hurvitz S. Trastuzumab Deruxtecan With Nivolumab in HER2-Expressing Metastatic Breast or Urothelial Cancer: Analysis of the Phase Ib DS8201-A-U105 Study. Clinical Cancer Research 2024 PMID: 39405343, DOI: 10.1158/1078-0432.ccr-24-1513.Peer-Reviewed Original ResearchMetastatic urothelial cancerMetastatic breast cancerT-DXdHER2-lowTrastuzumab deruxtecanUrothelial cancerHER2-positive metastatic breast cancerCohort 1Treatment-emergent adverse eventsMedian treatment durationIndependent central reviewData cutoffMetastatic breastCentral reviewPrimary endpointNivolumabCohort 4Adverse eventsBreast cancerCohort 3Cohort 2Evaluate efficacyTreatment durationPrompt interventionPatientsA 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 vedotin
2023
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.
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 1
2020
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.
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 neutropeniaAnalysis of clinical outcomes according to response status in prospective clinical trials of atezolizumab (atezo) in pretreated locally advanced/metastatic urothelial carcinoma (mUC).
Bedke J, Merseburger A, Loriot Y, Castellano D, Choy E, Duran I, Rosenberg J, Petrylak D, Dreicer R, Perez-Gracia J, Hoffman-Censits J, Van Der Heijden M, Degaonkar V, Thiebach L, de Ducla S, Fear S, Powles T, Sternberg C. Analysis of clinical outcomes according to response status in prospective clinical trials of atezolizumab (atezo) in pretreated locally advanced/metastatic urothelial carcinoma (mUC). Journal Of Clinical Oncology 2020, 38: 492-492. DOI: 10.1200/jco.2020.38.6_suppl.492.Peer-Reviewed Original ResearchMetastatic urothelial carcinomaStable diseasePartial responseDisease controlBaseline characteristicsRisk factorsPR/stable diseaseOverall survival durationProspective clinical trialsBroader patient populationAnalysis of outcomesData cutoffUnacceptable toxicityWorse OSComplete responseClinical outcomesMedian timeAnalysis populationPatient populationUrothelial carcinomaSurvival durationClinical trialsCohort 2Disease progressionResponse status
2019
Durability of complete response (CR) with atezolizumab (atezo) in locally advanced/metastatic urothelial carcinoma (mUC).
Loriot Y, Balar A, Dreicer R, Hoffman-Censits J, Perez-Gracia J, Petrylak D, Van Der Heijden M, Shen X, Zhu Q, Ding B, Kaiser C, Rosenberg J. Durability of complete response (CR) with atezolizumab (atezo) in locally advanced/metastatic urothelial carcinoma (mUC). Journal Of Clinical Oncology 2019, 37: 4527-4527. DOI: 10.1200/jco.2019.37.15_suppl.4527.Peer-Reviewed Original Research