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 interventionPatientsSacituzumab 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
2023
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.
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
2021
The efficacy of enzalutamide (ENZA) plus androgen deprivation therapy (ADT) on bone oligometastatic hormone-sensitive prostate cancer: A post hoc analysis of ARCHES.
Armstrong A, Iguchi T, Azad A, Villers A, Alekseev B, Petrylak D, Szmulewitz R, Alcaraz A, Shore N, Holzbeierlein J, Gomez-Veiga F, Rosbrook B, Zohren F, Haas G, Gourgioti G, El-Chaar N, Stenzl A. The efficacy of enzalutamide (ENZA) plus androgen deprivation therapy (ADT) on bone oligometastatic hormone-sensitive prostate cancer: A post hoc analysis of ARCHES. Journal Of Clinical Oncology 2021, 39: 5071-5071. DOI: 10.1200/jco.2021.39.15_suppl.5071.Peer-Reviewed Original ResearchMetastatic hormone-sensitive prostate cancerAndrogen deprivation therapyEfficacy of enzalutamideHormone-sensitive prostate cancerBone metastasesTreatment armsProstate cancerOligometastatic hormone-sensitive prostate cancerPrior docetaxel chemotherapySecondary clinical outcomesDeprivation therapyEfficacy outcomesRadiographic progressionSecondary endpointsBaseline characteristicsDisease volumeDocetaxel chemotherapyMetastatic burdenPolymetastatic diseaseArch studyClinical outcomesCentral reviewClinical benefitSafety profilePlacebo