2019
LBA52 Efficacy and safety of nivolumab in combination with docetaxel in men with metastatic castration-resistant prostate cancer in CheckMate 9KD
Fizazi K, Mella P, Castellano D, Minatta J, Kalebasty A, Shaffer D, Limon J, Armstrong A, Lopez H, Sharkey B, Saci A, Li J, Wang X, Ciprotti M, Sathyanarayana P, Saad F, Petrylak D, Retz M, Pachynski R, Drake C. LBA52 Efficacy and safety of nivolumab in combination with docetaxel in men with metastatic castration-resistant prostate cancer in CheckMate 9KD. Annals Of Oncology 2019, 30: v885-v886. DOI: 10.1093/annonc/mdz394.045.Peer-Reviewed Original ResearchMetastatic castration-resistant prostate cancerRadiographic progression-free survivalObjective response rateCastration-resistant prostate cancerBristol-Myers SquibbGenentech/RocheAssociation of biomarkersPersonal feesMeasurable diseaseProstate cancerGrade 3/4 treatment-related adverse eventsMedian radiographic progression-free survivalProstate-specific antigen (PSA) response rateResponse rateOngoing androgen deprivation therapyTreatment-related adverse eventsSafety of nivolumabAndrogen deprivation therapyPhase II studyPhase III trialsProgression-free survivalSanofi-AventisInterim analysis resultsMedical writing assistanceNon-financial support940P cfDNA is an acceptable but insufficient means of characterizing FGFR3 mutation in patients with metastatic urothelial cancer (mUC)
Pal S, Bajorin D, Hoffman-Censits J, Quinn D, Petrylak D, Galsky M, Vaishampayan U, De Giorgi U, Gupta S, Burris H, Soifer H, Li G, Dambkowski C, Moran S, Wang H, Daneshmand S, Rosenberg J. 940P cfDNA is an acceptable but insufficient means of characterizing FGFR3 mutation in patients with metastatic urothelial cancer (mUC). Annals Of Oncology 2019, 30: v377-v378. DOI: 10.1093/annonc/mdz249.037.Peer-Reviewed Original ResearchMetastatic urothelial cancerGenentech/RocheOverall response rateBristol-Myers SquibbComprehensive genomic profilingProgressive diseaseEMD SeronoFGFR3 mutationsTumor tissueSeattle GeneticsAstellas PharmaFGFR3 alterationsClovis OncologyRoche/GenentechGenomic alterationsPrior platinum-based chemotherapyBest overall response rateDisease control ratePhase Ib trialPlatinum-based chemotherapyTime of screeningMutations/fusionsBackground Previous studiesCancer Research NetworkWarrants further study853P ARCHES - The role of androgen deprivation therapy (ADT) with enzalutamide (ENZA) or placebo (PBO) in metastatic hormone-sensitive prostate cancer (mHSPC): Post hoc analyses of high and low disease volume and risk groups
Stenzl A, Szmulewitz R, Petrylak D, Holzbeierlein J, Villers A, Azad A, Alcaraz A, Alekseev B, Iguchi T, Shore N, Rosbrook B, Baron B, Haas G, Morlock R, Ramaswamy K, Armstrong A. 853P ARCHES - The role of androgen deprivation therapy (ADT) with enzalutamide (ENZA) or placebo (PBO) in metastatic hormone-sensitive prostate cancer (mHSPC): Post hoc analyses of high and low disease volume and risk groups. Annals Of Oncology 2019, 30: v332-v333. DOI: 10.1093/annonc/mdz248.010.Peer-Reviewed Original ResearchRadiographic progression-free survivalAndrogen deprivation therapyMetastatic hormone-sensitive prostate cancerCastration-resistant prostate cancerSymptomatic skeletal eventsProgression-free survivalDisease volumeOverall survivalRisk groupsAdverse eventsQuality of lifeAstellas PharmaBristol-Myers SquibbDeprivation therapyVisceral metastasesSkeletal eventsRadiographic responseTrial criteriaBone lesionsProstate cancerHigher QoLHormone-sensitive prostate cancerProstate-specific antigen progressionAstellas Pharma Inc.Genentech/Roche891TiP KEYNOTE-921: Phase III study of pembrolizumab (pembro) plus docetaxel and prednisone for enzalutamide (enza)- or abiraterone (abi)-pretreated patients (pts) with metastatic castration-resistant prostate cancer (mCRPC)
Petrylak D, Li B, Schloss C, Fizazi K. 891TiP KEYNOTE-921: Phase III study of pembrolizumab (pembro) plus docetaxel and prednisone for enzalutamide (enza)- or abiraterone (abi)-pretreated patients (pts) with metastatic castration-resistant prostate cancer (mCRPC). Annals Of Oncology 2019, 30: v351. DOI: 10.1093/annonc/mdz248.048.Peer-Reviewed Original ResearchMetastatic castration-resistant prostate cancerPrednisone/prednisoloneAndrogen deprivation therapySubsidiary of MerckDohme Corp.Merck SharpKey secondary efficacy end pointsRadiographic progression-free survivalRandomized phase 3 trialSecondary efficacy end pointsCastration-resistant prostate cancerAdequate organ functionECOG PS 0/1Subsequent anticancer therapyEfficacy end pointPhase 3 trialProgression-free survivalRadiographic disease progressionCT/MRIBristol-Myers SquibbAdult ptsDeprivation therapyPS 0/1RECIST v1.1Unacceptable toxicity895TiP A phase I study of AMG 160, a half-life extended bispecific T cell engager (HLE BiTE) immuno-oncology therapy targeting PSMA, in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC)
Tran B, Kouros-Mehr H, Fermin A, Horvath L, Roncolato F, Rettig M, Dorff T, Tagawa S, Subudhi S, Antonarakis E, Armstrong A, Petrylak D, Fizazi K, Salvati M, Scher H. 895TiP A phase I study of AMG 160, a half-life extended bispecific T cell engager (HLE BiTE) immuno-oncology therapy targeting PSMA, in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC). Annals Of Oncology 2019, 30: v353. DOI: 10.1093/annonc/mdz248.052.Peer-Reviewed Original ResearchMetastatic castration-resistant prostate cancerProstate-specific membrane antigenBristol-Myers SquibbPreliminary antitumor activityImmuno-oncology therapiesProstate cancerAntitumor activitySanofi-AventisCentral nervous system metastasesCastration-resistant prostate cancerBoehringer IngelheimContinuous androgen deprivation therapyEli LillySeattle GeneticsActive autoimmune diseaseGenentech/RochePFS/OSPhase 2 doseRECIST 1.1 criteriaTaxane-based regimensAndrogen deprivation therapyNervous system metastasesT effector cellsPhase 1 studyDuration of response927P 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 discontinuation870P A phase IIa study of radium-223 dichloride (Ra-223) alone or in combination with abiraterone acetate or enzalutamide in metastatic castration-resistant prostate cancer (mCRPC)
Petrylak D, Vaishampayan U, Patel K, Higano C, Albany C, Dawson N, Mehlhaff B, Quinn D, Nordquist L, Wagner V, Shen J, Trandafir L, Sartor O. 870P A phase IIa study of radium-223 dichloride (Ra-223) alone or in combination with abiraterone acetate or enzalutamide in metastatic castration-resistant prostate cancer (mCRPC). Annals Of Oncology 2019, 30: v340-v341. DOI: 10.1093/annonc/mdz248.027.Peer-Reviewed Original ResearchBone health agentsSSE-free survivalSymptomatic skeletal eventsMetastatic castration-resistant prostate cancerMedian overall survivalOverall survivalWeek 24Primary endpointBayer HealthCare PharmaceuticalsRa-223Open-label phase 2a studyTreatment-emergent adverse eventsBayer PharmaceuticalsCastration-resistant prostate cancerSeattle GeneticsPhase 2a studyPhase IIa studyRadium-223 dichlorideSmall study populationBristol-Myers SquibbALSYMPCA studyECOG 0/1Prior therapySecondary endpointsTreatment discontinuation901O EV-103: Initial results of enfortumab vedotin plus pembrolizumab for locally advanced or metastatic urothelial carcinoma
Hoimes C, Rosenberg J, Srinivas S, Petrylak D, Milowsky M, Merchan J, Bilen M, Gupta S, Carret A, Yuan N, Melhem-Bertrandt A, Flaig T. 901O EV-103: Initial results of enfortumab vedotin plus pembrolizumab for locally advanced or metastatic urothelial carcinoma. Annals Of Oncology 2019, 30: v356. DOI: 10.1093/annonc/mdz249.Peer-Reviewed Original ResearchBristol-Myers SquibbMetastatic urothelial carcinomaAdverse eventsSeattle GeneticsUrothelial carcinomaDay 1Common treatment-emergent adverse eventsEli LillyTreatment-emergent adverse eventsDose-escalation cohortsGenentech/RocheImmune-mediated eventsPhase 1b studyPost-baseline scanSafety/tolerabilityManageable safety profileSystemic steroid treatmentKey secondary objectiveStandard of careBavarian NordicFortress BiotechMonotherapy dataRECIST 1.1Encouraging efficacyPrimary endpoint902O An adaptive, biomarker directed platform study in metastatic urothelial cancer (BISCAY) with durvalumab in combination with targeted therapies
Powles T, Balar A, Gravis G, Jones R, Ravaud A, Florence J, Grivas P, Petrylak D, Galsky M, Carles J, Sridhar S, Arkenau H, Carroll D, DeCesare J, Mercier F, Hodgson D, Stone J, Cosaert J, Landers D. 902O An adaptive, biomarker directed platform study in metastatic urothelial cancer (BISCAY) with durvalumab in combination with targeted therapies. Annals Of Oncology 2019, 30: v356-v357. DOI: 10.1093/annonc/mdz249.001.Peer-Reviewed Original ResearchSarah Cannon Research InstituteBristol-Myers SquibbGenentech/RocheUrothelial cancerSeattle GeneticsMonotherapy armArm BClovis OncologyRoche LaboratoriesAstellas PharmaNext-generation sequencingRoche-GenentechAdvanced urothelial cancerConclusions Combination treatmentNon-randomized controlsMetastatic urothelial cancerPD-L1 expressionKey secondary objectivePD-L1 inhibitorsTumor DNA alterationsEli LillyBavarian NordicConfirmed responsesD monotherapyOS rates919P Three-year follow-up from the phase III KEYNOTE-045 trial: Pembrolizumab (Pembro) versus investigator’s choice (paclitaxel, docetaxel, or vinflunine) in recurrent, advanced urothelial cancer (UC)
Necchi A, Fradet Y, Bellmunt J, de Wit R, Lee J, Fong L, Vozelgang N, Climent M, Petrylak D, Choueiri T, Gerritsen W, Gurney H, Quinn D, Culine S, Sternberg C, Nam K, Frenkl T, Godwin J, Bajorin D, Vaughn D. 919P Three-year follow-up from the phase III KEYNOTE-045 trial: Pembrolizumab (Pembro) versus investigator’s choice (paclitaxel, docetaxel, or vinflunine) in recurrent, advanced urothelial cancer (UC). Annals Of Oncology 2019, 30: v366-v367. DOI: 10.1093/annonc/mdz249.018.Peer-Reviewed Original ResearchGenentech/RocheDuration of responseCaris Life SciencesBristol-Myers SquibbMetastatic urothelial cancerSubsidiary of MerckUrothelial cancerDohme Corp.US OncologyMerck SharpAdverse eventsRoche LaboratoriesJanssen-CilagInvestigator's choiceKey secondary end pointMedian DORTreatment-related adverse eventsSeattle GeneticsAdvanced urothelial cancerECOG PS 0Kidney Cancer AssociationPlatinum-containing regimenSecondary end pointsAstellas PharmaCancer Study Group921P Quality of life of metastatic urothelial cancer (mUC) patients treated with enfortumab vedotin (EV) following platinum-containing chemotherapy and a checkpoint inhibitor (CPI): Data from EV-201 cohort 1
McGregor B, O’Donnell P, Balar A, Petrylak D, Rosenberg J, Yu E, Quinn D, Shah S, Pinelli J, Hepp Z, Galsky M. 921P Quality of life of metastatic urothelial cancer (mUC) patients treated with enfortumab vedotin (EV) following platinum-containing chemotherapy and a checkpoint inhibitor (CPI): Data from EV-201 cohort 1. Annals Of Oncology 2019, 30: v367-v368. DOI: 10.1093/annonc/mdz249.020.Peer-Reviewed Original ResearchBristol-Myers SquibbGenentech/RochePlatinum-containing chemotherapyEnfortumab vedotinVisual analog scaleCheckpoint inhibitorsCohort 1EMD SeronoSeattle GeneticsAstellas Pharma Inc.Metastatic urothelial cancer patientsPatient-reported outcome measuresSelf-rated health statusPain/discomfortUrothelial cancer patientsGreater symptom burdenAnxiety/depressionEQ-5D utilitiesMUC patientsPrior chemotherapyExploratory endpointsSymptom burdenVAS scoresCancer QualityCycle 5LBA55 Initial results from TROPHY-U-01: A phase II open-label study of sacituzumab govitecan in patients (Pts) with metastatic urothelial cancer (mUC) after failure of platinum-based regimens (PLT) or immunotherapy
Tagawa S, Balar A, Petrylak D, Grivas P, Agarwal N, Sternberg C, Hong Q, Gladden A, Kanwal C, Siemon-Hryczyk P, Goswami T, Itri L, Loriot Y. LBA55 Initial results from TROPHY-U-01: A phase II open-label study of sacituzumab govitecan in patients (Pts) with metastatic urothelial cancer (mUC) after failure of platinum-based regimens (PLT) or immunotherapy. Annals Of Oncology 2019, 30: v890-v891. DOI: 10.1093/annonc/mdz394.049.Peer-Reviewed Original ResearchMetastatic urothelial cancerPlatinum-based regimensBristol-Myers SquibbSacituzumab govitecanCheckpoint inhibitorsTrial conductionScientific Advisory BoardSeattle GeneticsBavarian NordicEMD SeronoCohort 1Phase II open-label studyPhase I/II studyECOG performance status 0Boehringer IngelheimPre-planned interim analysisHigh unmet medical needClovis OncologyTreatment-related AEsAntitumor activityOpen-label studyPerformance status 0Significant clinical activitySingle-agent chemotherapyTreatment-related deaths
2014
774P Stride, a Randomized, Phase 2, Open-Label Study of Sipuleucel-T with Concurrent Vs Sequential Enzalutamide in Metastatic Castration-Resistant Prostate Cancer (Mcrpc)
Petrylak D, Quinn D, Dreicer R, Antonarakis E, Shore N, Corman J, Concepcion R, Pieczonka C, Stubbs A, Sheikh N, Devries T, Sandler A, Drake C. 774P Stride, a Randomized, Phase 2, Open-Label Study of Sipuleucel-T with Concurrent Vs Sequential Enzalutamide in Metastatic Castration-Resistant Prostate Cancer (Mcrpc). Annals Of Oncology 2014, 25: iv266. DOI: 10.1093/annonc/mdu336.22.Peer-Reviewed Original ResearchAdverse eventsArm ABristol-Myers SquibbArm B.Immune responsePeripheral T-cell immune responseMetastatic castration-resistant prostate cancerCastration-resistant prostate cancerElevated serum PSA levelsT cell immune responsesAutologous cellular immunotherapyTreatment of mCRPCTreatment-related gradePeripheral immune responsePhase 2 studySerum PSA levelsAndrogen receptor inhibitorMultiple treatment optionsCell immune responsesSecondary endpointsPrimary endpointPSA levelsInfusion 2Cellular immunotherapyInfusion 1
2012
943P Openact: Phase 2, Open-Label Study of Sipuleucel-T in Metastatic Castrate-Resistant Prostate Cancer (MCRPC)
Corman J, Dawson N, Hall S, Nabhan C, Ferrari A, Armstrong A, Murdock M, Stewart F, Sheikh N, Petrylak D. 943P Openact: Phase 2, Open-Label Study of Sipuleucel-T in Metastatic Castrate-Resistant Prostate Cancer (MCRPC). Annals Of Oncology 2012, 23: ix311. DOI: 10.1016/s0923-7534(20)33504-3.Peer-Reviewed Original ResearchMetastatic castrate-resistant prostate cancerTotal nucleated cell countImmune responseHigher baseline prostate-specific antigenPhase 2 open-label studyCell countBaseline prostate-specific antigenAntigen-specific immune responsesCastrate-resistant prostate cancerT cell proliferative responsesAutologous cellular immunotherapyCostimulatory molecules CD54Sipuleucel-T treatmentOpen-label studySpeakers bureauHigher total nucleated cell countSanofi-AventisVirginia Mason Medical CenterRisk of deathCell proliferative responsesProstate-specific antigenNucleated cell countD exposureBristol-Myers SquibbCD54 upregulation
2006
Neoadjuvant paclitaxel (P), carboplatin (Ca) and gemcitabine (G) in patients with locally advanced transitional cell carcinoma (TCC) of the bladder: A final report
Smith D, Mackler N, Hussain M, Dunn R, Montie J, Wood D, Lee C, Petrylak D, Quinn D, Vaishampayan U. Neoadjuvant paclitaxel (P), carboplatin (Ca) and gemcitabine (G) in patients with locally advanced transitional cell carcinoma (TCC) of the bladder: A final report. Journal Of Clinical Oncology 2006, 24: 4541-4541. DOI: 10.1200/jco.2006.24.18_suppl.4541.Peer-Reviewed Original ResearchTransitional cell carcinomaAdvanced transitional cell carcinomaPT0 rateArm IArm IITreatment of TCCGrade 3/4 hematologic toxicitiesM0 transitional cell carcinomaAdequate organ functionCycles of therapyGrade 3 toxicityPerformance status 0Pathologic complete respondersNational Cancer InstituteBristol-Myers SquibbNeoadjuvant paclitaxelStatus 0Complete respondersEvaluable subjectsHematologic toxicityNeoadjuvant chemotherapyPrimary endpointPositive patientsResection rateClinical T3