2023
Avelumab First-line Maintenance Therapy for Advanced Urothelial Carcinoma: Comprehensive Clinical Subgroup Analyses from the JAVELIN Bladder 100 Phase 3 Trial
Grivas P, Park S, Voog E, Caserta C, Gurney H, Bellmunt J, Kalofonos H, Ullén A, Loriot Y, Sridhar S, Yamamoto Y, Petrylak D, Sternberg C, Gupta S, Huang B, Costa N, Laliberte R, di Pietro A, Valderrama B, Powles T. Avelumab First-line Maintenance Therapy for Advanced Urothelial Carcinoma: Comprehensive Clinical Subgroup Analyses from the JAVELIN Bladder 100 Phase 3 Trial. European Urology 2023, 84: 95-108. PMID: 37121850, DOI: 10.1016/j.eururo.2023.03.030.Peer-Reviewed Original ResearchConceptsBest supportive careProgression-free survivalAdvanced urothelial carcinomaPlatinum-based chemotherapyOverall survivalHazard ratioUrothelial carcinomaAnalysis of OSFirst-line maintenance therapyRelevant subgroupsCox proportional hazards modelClinical subgroup analysisPhase 3 trialKaplan-Meier methodProportional hazards modelFirst-line maintenanceMetastatic UCMaintenance therapyStable diseaseSupportive careComplete responsePartial responseAdvanced cancerPD-L1Maintenance treatment
2021
Sapanisertib, a dual mTORC1/2 inhibitor, for TSC1- or TSC2- mutated metastatic urothelial carcinoma (mUC).
Kim J, Milowsky M, Hahn N, Kwiatkowski D, Morgans A, Davis N, Appleman L, Gupta S, Lara P, Hoffman-Censits J, Quinn D, Shyr Y, LoRusso P, Sklar J, Petrylak D. Sapanisertib, a dual mTORC1/2 inhibitor, for TSC1- or TSC2- mutated metastatic urothelial carcinoma (mUC). Journal Of Clinical Oncology 2021, 39: 431-431. DOI: 10.1200/jco.2021.39.6_suppl.431.Peer-Reviewed Original ResearchMetastatic urothelial carcinomaStable diseaseAdverse eventsObjective responseWithdrew consentTSC2 mutationsUrothelial carcinomaTSC1 mutationsTumor samplesCommon adverse eventsMedian overall survivalTreatment-related deathsPhase II studyCentral labOverall response rateDual mTORC1/2 inhibitorUnknown mutational statusCentral confirmationEligible patientsEvaluable patientsMUC patientsRestaging scanII studyPrimary endpointBaseline characteristics
2020
Maintenance avelumab + best supportive care (BSC) versus BSC alone after platinum-based first-line (1L) chemotherapy in advanced urothelial carcinoma (UC): JAVELIN Bladder 100 phase III interim analysis.
Powles T, Park S, Voog E, Caserta C, Valderrama B, Gurney H, Kalofonos H, Radulovic S, Demey W, Ullén A, Loriot Y, Sridhar S, Tsuchiya N, Kopyltsov E, Sternberg C, Bellmunt J, Aragon-Ching J, Petrylak D, di Pietro A, Grivas P. Maintenance avelumab + best supportive care (BSC) versus BSC alone after platinum-based first-line (1L) chemotherapy in advanced urothelial carcinoma (UC): JAVELIN Bladder 100 phase III interim analysis. Journal Of Clinical Oncology 2020, 38: lba1-lba1. DOI: 10.1200/jco.2020.38.18_suppl.lba1.Peer-Reviewed Original ResearchBest supportive careAdvanced urothelial carcinomaProgression-free survivalMedian overall survivalOverall survivalPlatinum-based chemotherapyPD-L1Urothelial carcinomaAdverse eventsSupportive carePlatinum-based first-line chemotherapyCausality adverse eventsCycles of gemcitabineFirst-line chemotherapyMetastatic urothelial carcinomaPhase 3 trialUrinary tract infectionIndependent central reviewEligible patientsNonvisceral diseaseOS benefitStable diseaseMaintenance therapyPrimary endpointSecondary endpointsAnalysis 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
2017
A multicohort phase I study of ramucirumab (R) plus pembrolizumab (P): Interim safety and clinical activity in patients with urothelial carcinoma.
Petrylak D, Arkenau H, Perez-Gracia J, Krebs M, Santana-Davila R, Yang J, Rege J, Mi G, Ferry D, Herbst R. A multicohort phase I study of ramucirumab (R) plus pembrolizumab (P): Interim safety and clinical activity in patients with urothelial carcinoma. Journal Of Clinical Oncology 2017, 35: 349-349. DOI: 10.1200/jco.2017.35.6_suppl.349.Peer-Reviewed Original ResearchTreatment-related AEsECOG PS 0Median durationPS 0PD-L1Urothelial carcinomaDay 1Phase 1a/b trialPlatinum-based systemic therapyTreatment-related grade 4Advanced urothelial carcinomaElevated alanine aminotransferaseNew safety signalsElevated aspartate aminotransferaseBaseline tumor tissuePreliminary efficacy dataTransitional cell carcinomaEligible ptsMeasurable diseaseMedian PFSStable diseasePartial responseProgressive diseaseSystemic therapyMedian age
2015
Association of changes in measurable disease by RECIST with survival in metastatic castration-resistant prostate cancer (mCRPC).
Sonpavde G, Pond G, Templeton A, Petrylak D, Tombal B, Rosenthal M, Tannock I. Association of changes in measurable disease by RECIST with survival in metastatic castration-resistant prostate cancer (mCRPC). Journal Of Clinical Oncology 2015, 33: 186-186. DOI: 10.1200/jco.2015.33.7_suppl.186.Peer-Reviewed Original ResearchMetastatic castration-resistant prostate cancerProgressive diseaseOverall survivalPartial responseAssociation of changesMeasurable diseaseStable diseaseHazard ratioLandmark analysisDay 90Castration-resistant prostate cancerWorld Health Organization criteriaMeasurable disease responseUnconfirmed partial responseECOG performance statusMedian overall survivalNeutrophil-lymphocyte ratioPhase II trialResponse Evaluation CriteriaProportional hazards regressionAccrual of patientsType of progressionMeasurable lesionsRECIST 1.0VENICE trial
2012
Randomized phase II trial of maintenance sunitinib versus placebo following response to chemotherapy (CT) for patients (pts) with advanced urothelial carcinoma (UC).
Grivas P, Nanus D, Stadler W, Daignault S, Dreicer R, Kohli M, Petrylak D, Vaughn D, Bylow K, Belldegrun A, Sottnik J, Keller E, Smith D, Hussain M. Randomized phase II trial of maintenance sunitinib versus placebo following response to chemotherapy (CT) for patients (pts) with advanced urothelial carcinoma (UC). Journal Of Clinical Oncology 2012, 30: 265-265. DOI: 10.1200/jco.2012.30.5_suppl.265.Peer-Reviewed Original ResearchOpen-label sunitinibAdvanced urothelial carcinomaUrothelial carcinomaMaintenance sunitinibProgression rateResponse rateMedian age 69 yearsRandomized phase II trialAdequate organ functionECOG PS 0ECOG PS 1Objective response rateCycles of chemotherapyVEGF/Age 69 yearsPhase II trialSerum level changesProgression of UCMedian TTPSecondary endpointsStable diseaseII trialOral sunitinibPS 0Complete response
2011
Preliminary Results of An Ongoing Phase I Trial of Oral Belinostat a Novel Histone Deacetylase Inhibitor in Patients with Lymphoid Malignancies,
Zain J, Foss F, Diefenbach C, Petrylak D, Narwal A, Neylon E, Knoblauch P, O'Connor O. Preliminary Results of An Ongoing Phase I Trial of Oral Belinostat a Novel Histone Deacetylase Inhibitor in Patients with Lymphoid Malignancies,. Blood 2011, 118: 3710. DOI: 10.1182/blood.v118.21.3710.3710.Peer-Reviewed Original ResearchHistone deacetylase inhibitorsTumor shrinkageSolid tumorsDeacetylase inhibitorsIntra-patient dose escalationOngoing phase I trialClass I/II histone deacetylase inhibitorEarly tumor shrinkageGrade 3 diarrheaMedian age 48Frequent adverse eventsNovel histone deacetylase inhibitorPhase I trialHighest dose levelMantle cell lymphomaAnorexia/Dose cohortsEvaluable diseaseQ3w scheduleStable diseaseAdverse eventsDaily doseDose escalationI trialNHL patients
2009
Final results of a phase I study of oral belinostat (PXD101) in patients with lymphoma
Zain J, Foss F, Kelly W, DeBono J, Petrylak D, Narwal A, Neylon E, Blumenschein G, Lassen U, O'Connor O. Final results of a phase I study of oral belinostat (PXD101) in patients with lymphoma. Journal Of Clinical Oncology 2009, 27: 8580-8580. DOI: 10.1200/jco.2009.27.15_suppl.8580.Peer-Reviewed Original ResearchNon-Hodgkin lymphomaHodgkin's diseaseDose escalationTumor shrinkageSolid tumorsIntra-patient dose escalationRefractory non-Hodgkin lymphomaPhase IAcceptable organ functionEarly tumor shrinkageMedian age 51Frequent adverse eventsPossible dose escalationMantle cell lymphomaHistone deacetylase inhibitorsEvaluable diseaseLeg DVTPrior regimensQ3w scheduleStable diseaseAdverse eventsDaily doseSafety profileCohort C.Preclinical activity
2006
A phase I open-label, dose escalation study to determine the maximum tolerated dose and to evaluate the safety profile of lenalidomide with every three week docetaxel in subjects with androgen independent prostate cancer
Moss R, Shelton G, Melia J, Mohile S, Petrylak D. A phase I open-label, dose escalation study to determine the maximum tolerated dose and to evaluate the safety profile of lenalidomide with every three week docetaxel in subjects with androgen independent prostate cancer. Journal Of Clinical Oncology 2006, 24: 14618-14618. DOI: 10.1200/jco.2006.24.18_suppl.14618.Peer-Reviewed Original ResearchAndrogen-independent prostate cancerIndependent prostate cancerMeasurable diseaseProstate cancerSerum prostate-specific antigen levelProstate-specific antigen levelDose escalation schedulePrior chemotherapy regimensEvidence of progressionFurther dose escalationPhase I trialSpecific antigen levelsEfficacy of docetaxelDerivative of thalidomideAntiandrogen withdrawalL1 patientsPalliative RTPo bidStable diseaseChemotherapy regimensMedian PSARECIST criteriaEscalation studySerum PSABone metastasesA Phase I Trial of Pox PSA vaccines (PROSTVAC®-VF) with B7-1, ICAM-1, and LFA-3 co-stimulatory molecules (TRICOM™) in Patients with Prostate Cancer
DiPaola R, Plante M, Kaufman H, Petrylak D, Israeli R, Lattime E, Manson K, Schuetz T. A Phase I Trial of Pox PSA vaccines (PROSTVAC®-VF) with B7-1, ICAM-1, and LFA-3 co-stimulatory molecules (TRICOM™) in Patients with Prostate Cancer. Journal Of Translational Medicine 2006, 4: 1. PMID: 16390546, PMCID: PMC1360095, DOI: 10.1186/1479-5876-4-1.Peer-Reviewed Original ResearchProstate-specific antigenSerious adverse eventsAdverse eventsProstate cancerB7-1ICAM-1Co-stimulatory molecules B7-1Mean prostate-specific antigenRecombinant vaccinia virus vaccineAndrogen-independent prostate cancerFurther phase IIPreliminary clinical activityInjection site reactionsPhase I trialVaccinia virus vaccineCo-stimulatory moleculesIndependent prostate cancerFeasible therapeutic approachRecombinant fowlpox virusStable diseaseMetastatic diseaseProgressive diseaseI trialTherapeutic vaccinesSafety profile