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 interventionPatients
2019
927P Clinical outcomes by sex with atezolizumab (atezo) monotherapy in patients (pts) with locally advanced/metastatic urothelial carcinoma (mUC)
Hoffman-Censits J, Rosenberg J, van Der Heijden M, Dreicer R, Gracia J, Petrylak D, Retz M, Sabbatini R, Naglieri E, Caserta C, Maruzzo M, Iacovelli R, Galli L, McDermott R, Barrera R, Bonfill T, De Ducla S, Ding B, Linsenmeier J, Sternberg C. 927P Clinical outcomes by sex with atezolizumab (atezo) monotherapy in patients (pts) with locally advanced/metastatic urothelial carcinoma (mUC). Annals Of Oncology 2019, 30: v372-v373. DOI: 10.1093/annonc/mdz249.026.Peer-Reviewed Original ResearchMetastatic urothelial carcinomaBody mass indexF. Hoffmann-La RochePersonal feesBristol-Myers SquibbHoffmann-La RocheCohort 1Roche/GenentechMedian body mass indexSeattle GeneticsMedian treatment durationObjective response rateSignificant OS differenceOverall survival outcomesDifferent treatment settingsSignificant differencesBristol-Meyers SquibbAtezolizumab monotherapyECOG PSFortress BiotechMale ptsMedian OSOS benefitWeill Cornell MedicineTreatment discontinuation
2018
Enfortumab vedotin (EV) in patients (Pts) with metastatic urothelial carcinoma (mUC) with prior checkpoint inhibitor (CPI) failure: A prospective cohort of an ongoing phase 1 study.
Petrylak D, Smith D, Flaig T, Zhang J, Sridhar S, Ruether J, Plimack E, Merchan J, Quinn D, Kilari D, Srinivas S, Baranda J, Lang J, Milowsky M, Galsky M, Spira A, Gartner E, Wu C, Melhem-Bertrandt A, Rosenberg J. Enfortumab vedotin (EV) in patients (Pts) with metastatic urothelial carcinoma (mUC) with prior checkpoint inhibitor (CPI) failure: A prospective cohort of an ongoing phase 1 study. Journal Of Clinical Oncology 2018, 36: 431-431. DOI: 10.1200/jco.2018.36.6_suppl.431.Peer-Reviewed Original ResearchMetastatic urothelial carcinomaOngoing phase 1 studiesPhase 1 studyLiver metastasesEvaluable ptsDisease progressionNectin-4High unmet medical needPhase 2 dosePost-baseline scanAntitumor activityMedian treatment durationPhase 2 studyPrimary tumor siteHigh unmet needUnmet medical needMonomethyl auristatin E.CPI therapyFatal AEsPrior chemotherapyPrior therapyRECIST v1.1Unconfirmed PRMetastatic settingPrimary endpoint
2017
A phase I study of enfortumab vedotin (ASG-22CE; ASG-22ME): Updated analysis of patients with metastatic urothelial cancer.
Petrylak D, Perez R, Zhang J, Smith D, Ruether J, Sridhar S, Sangha R, Lang J, Heath E, Merchan J, Gartner E, Chu R, Anand B, Doñate F, Jackson L, Adams J, Melhem-Bertrandt A, Rosenberg J. A phase I study of enfortumab vedotin (ASG-22CE; ASG-22ME): Updated analysis of patients with metastatic urothelial cancer. Journal Of Clinical Oncology 2017, 35: 106-106. DOI: 10.1200/jco.2017.35.15_suppl.106.Peer-Reviewed Original ResearchTreatment-related adverse eventsMetastatic urothelial cancerOverall response rateNectin-4 expressionUrothelial cancerAntitumor activityMost treatment-related adverse eventsImmune checkpoint inhibitor therapyMedian progression-free survivalPhase IPrior chemotherapy regimenTreatment-related deathsCheckpoint inhibitor therapyMedian treatment durationFavorable tolerability profilePost-baseline assessmentProgression-free survivalUrinary tract infectionAnalysis of patientsMonomethyl auristatin EDifferent dose levelsArchival tumor specimensAntibody-drug conjugatesEvaluable ptsPrior therapy
2016
IMvigor 210, a phase II trial of atezolizumab (MPDL3280A) in platinum-treated locally advanced or metastatic urothelial carcinoma (mUC).
Hoffman-Censits J, Grivas P, Van Der Heijden M, Dreicer R, Loriot Y, Retz M, Vogelzang N, Perez-Gracia J, Rezazadeh A, Bracarda S, Yu E, Hoimes C, Bellmunt J, Quinn D, Petrylak D, Hussain S, Cui N, Mariathasan S, Abidoye O, Rosenberg J. IMvigor 210, a phase II trial of atezolizumab (MPDL3280A) in platinum-treated locally advanced or metastatic urothelial carcinoma (mUC). Journal Of Clinical Oncology 2016, 34: 355-355. DOI: 10.1200/jco.2016.34.2_suppl.355.Peer-Reviewed Original ResearchMetastatic urothelial carcinomaPoor prognostic factorPrognostic factorsPD-L1Prognostic subgroupsPD-L1/PDImmune cell statusMedian treatment durationPD-L1 subgroupsTreatment-related AEsPD-L1 expressionPD-L1 statusPhase II trialPlatinum-based chemotherapyCo-primary endpointsPoor prognostic subgroupMUC patientsRECIST v1.1Data cutoffDurable responsesII trialAntitumor immunityG3-4Median ageHistoric controls