2020
MEDI3726, a prostate-specific membrane antigen (PSMA)-targeted antibody-drug conjugate (ADC) in mCRPC after failure of abiraterone or enzalutamide.
De Bono J, Fleming M, Wang J, Cathomas R, Williams M, Bothos J, Balic K, Cho S, Martinez P, Petrylak D. MEDI3726, a prostate-specific membrane antigen (PSMA)-targeted antibody-drug conjugate (ADC) in mCRPC after failure of abiraterone or enzalutamide. Journal Of Clinical Oncology 2020, 38: 99-99. DOI: 10.1200/jco.2020.38.6_suppl.99.Peer-Reviewed Original ResearchDrug-related adverse eventsAdverse eventsAntibody-drug conjugatesMedian progression-free survivalComposite response rateGrade 3 thrombocytopeniaMedian overall survivalProgression-free survivalTaxane-based therapyPhase 1 studyDuration of responseProstate-specific membrane antigenDrug-related deathsTumor cell countPrior regimensRECIST v1.1Grade 3/4PSA decreaseStarting doseOverall survivalUnacceptable toxicityMedian ageDose escalationAntidrug antibodiesEfficacy analysisFORT-1: Phase II/III study of rogaratinib versus chemotherapy (CT) in patients (pts) with locally advanced or metastatic urothelial carcinoma (UC) selected based on FGFR1/3 mRNA expression.
Quinn D, Petrylak D, Bellmunt J, Necchi A, Gurney H, Lee J, Van Der Heijden M, Rosenbaum E, Penel N, Pang S, Li J, Garcia del Muro X, Joly F, Papai Z, Ellinghaus P, Lu C, Nakajima K, Ishida T, Nishiyama H, Sternberg C. FORT-1: Phase II/III study of rogaratinib versus chemotherapy (CT) in patients (pts) with locally advanced or metastatic urothelial carcinoma (UC) selected based on FGFR1/3 mRNA expression. Journal Of Clinical Oncology 2020, 38: 489-489. DOI: 10.1200/jco.2020.38.6_suppl.489.Peer-Reviewed Original ResearchMetastatic urothelial carcinomaUrothelial carcinomaPhase II/III studyMedian progression-free survivalTreatment-emergent adverse eventsMuscle-invasive urothelial carcinomaPhase II/IIIDisease control rateOpen-label studyProgression-free survivalStage IV diseaseAcceptable safety profileUrinary tract infectionDNA alterationsStage IIIBIII studyPrior immunotherapyStandard chemotherapyTract infectionsAdverse eventsMedian agePlatinum chemotherapySafety profileControl rateSubgroup analysis
2018
Overall survival between African-American (AA) and Caucasian (C) men with metastatic castration-resistant prostate cancer (mCRPC).
Halabi S, Dutta S, Tangen C, Rosenthal M, Petrylak D, Thompson I, Chi K, De Bono J, Fandi A, Araujo J, Eisenberger M, Logothetis C, Quinn D, Fizazi K, Higano C, George D, Morris M, Small E, Tannock I, Kelly W. Overall survival between African-American (AA) and Caucasian (C) men with metastatic castration-resistant prostate cancer (mCRPC). Journal Of Clinical Oncology 2018, 36: lba5005-lba5005. DOI: 10.1200/jco.2018.36.18_suppl.lba5005.Peer-Reviewed Original ResearchMetastatic castration-resistant prostate cancerCastration-resistant prostate cancerDocetaxel/prednisoneOverall survivalCaucasian manHazard ratioLymph nodesRisk factorsProstate cancerMedian overall survivalPerformance status 0Phase III trialsPooled hazard ratioShorter overall survivalIndividual patient dataProportional hazards modelAfrican American menStatus 0Primary endpointIII trialsMedian hemoglobinMedian ageLiver diseaseMultivariable analysisPrognostic importanceOverall survival and immune responses with sipuleucel-T and enzalutamide: STRIDE study.
Petrylak D, Drake C, Pieczonka C, Corman J, Garcia J, Dunshee C, Van Mouwerik T, Tyler R, Chang N, Quinn D. Overall survival and immune responses with sipuleucel-T and enzalutamide: STRIDE study. Journal Of Clinical Oncology 2018, 36: 246-246. DOI: 10.1200/jco.2018.36.6_suppl.246.Peer-Reviewed Original ResearchDisease progressionMetastatic castration-resistant prostate cancerCastration-resistant prostate cancerKaplan-Meier analysisNew safety concernsMedian followBaseline characteristicsOverall survivalPSA responseMedian ageClinical outcomesHormonal agentsProstate cancerClinical impactLaboratory valuesSTRIDE studyImmune responseLarger studySipuleucelWkSafety concernsFirst studyImmunotherapyPatientsFollow
2017
Phase 1 study of the PSMA-targeted small-molecule drug conjugate EC1169 in patients with metastatic castrate-resistant prostate cancer (mCRPC).
Morris M, Vogelzang N, Sartor O, Armour A, Groaning M, Robarts A, Petrylak D, Tolcher A, Gordon M, Babiker H. Phase 1 study of the PSMA-targeted small-molecule drug conjugate EC1169 in patients with metastatic castrate-resistant prostate cancer (mCRPC). Journal Of Clinical Oncology 2017, 35: 5038-5038. DOI: 10.1200/jco.2017.35.15_suppl.5038.Peer-Reviewed Original ResearchMetastatic castrate-resistant prostate cancerProstate-specific membrane antigenRadiographic progression-free survivalProstate cancerMedian radiographic progression-free survivalCastrate-resistant prostate cancerProgression-free survivalPhase 1 studySoft tissue diseasePatient selection toolPotential therapeutic targetAnti-tumor activityB ptsMost normal tissuesG3 thrombocytopeniaExpansion cohortPrimary endpointDose escalationMedian ageTissue diseaseRadiographic assessmentMedian numberDisease localizationDose reductionPart BA 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
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
2012
Correlation of progression-free survival at 6 months (PFS6) with overall survival at 12 months (OS12) in an analysis of 10 trials of second-line therapy for advanced urothelial carcinoma (UC).
Maughan B, Boucher K, Agarwal N, Choueiri T, Qu A, Vogelzang N, Fougeray R, Niegisch G, Albers P, Wong Y, Ko Y, Sridhar S, Galsky M, Petrylak D, Vaishampayan U, Beer T, Sternberg C, Rosenberg J, Molins J, Sonpavde G. Correlation of progression-free survival at 6 months (PFS6) with overall survival at 12 months (OS12) in an analysis of 10 trials of second-line therapy for advanced urothelial carcinoma (UC). Journal Of Clinical Oncology 2012, 30: 4525-4525. DOI: 10.1200/jco.2012.30.15_suppl.4525.Peer-Reviewed Original ResearchSecond-line therapyAdvanced urothelial carcinomaPhase II trialUrothelial carcinomaIndividual-level agreementResponse rateII trialIndividual patient progressionProgression-free survivalAssociation of responsePearson's chi-square testDuration of benefitSignificant unmet needRandom-effects modelChi-square testPearson correlationPrimary endpointVisceral metastasesOverall survivalPerformance statusMedian ageYates' continuity correctionPatient progressionIntermediate endpointsPFS6