2023
Combination Treatment with Sipuleucel-T and Abiraterone Acetate or Enzalutamide for Metastatic Castration-Resistant Prostate Cancer: STAMP and STRIDE Trials
Antonarakis E, Subudhi S, Pieczonka C, Karsh L, Quinn D, Hafron J, Wilfehrt H, Harmon M, Sheikh N, Shore N, Petrylak D. Combination Treatment with Sipuleucel-T and Abiraterone Acetate or Enzalutamide for Metastatic Castration-Resistant Prostate Cancer: STAMP and STRIDE Trials. Clinical Cancer Research 2023, 29: 2426-2434. PMID: 37058234, PMCID: PMC10320463, DOI: 10.1158/1078-0432.ccr-22-3832.Peer-Reviewed Original ResearchConceptsMetastatic castration-resistant prostate cancerAndrogen receptor-targeted agentsMedian overall survivalCastration-resistant prostate cancerOverall survivalNational Death IndexConcurrent administrationProstate cancerAntigen-presenting cell activationCurrent prescribing informationNew safety signalsKaplan-Meier methodologyLong-term outcomesConfidence intervalsReceptor-targeted agentsProstatic acid phosphataseAbiraterone acetateFirst infusionDeath IndexPrescribing informationHumoral responseSubsequent infusionSequential administrationSafety signalsImmune response
2021
First-in-human, phase I study of PF-06753512, a vaccine-based immunotherapy regimen (PrCa VBIR), in biochemical relapse (BCR) and metastatic castration-resistant prostate cancer (mCRPC).
Autio K, Higano C, Nordquist L, Appleman L, Zhang T, Zhu X, Babiker H, Vogelzang N, Prasad S, Schweizer M, Billotte S, Binder J, Cavazos N, Li R, Chan K, Cho H, Dermyer M, Hollingsworth R, Kern K, Petrylak D. First-in-human, phase I study of PF-06753512, a vaccine-based immunotherapy regimen (PrCa VBIR), in biochemical relapse (BCR) and metastatic castration-resistant prostate cancer (mCRPC). Journal Of Clinical Oncology 2021, 39: 2612-2612. DOI: 10.1200/jco.2021.39.15_suppl.2612.Peer-Reviewed Original ResearchMetastatic castration-resistant prostate cancerTreatment-related adverse eventsImmune checkpoint inhibitorsBiochemical relapseImmune responseCastration-resistant prostate cancerPhase INovel hormone therapyAntitumor activityManageable safety profileObjective tumor responsePD-1 antibodyAntigen-specific immunityProstate-specific membrane antigenAndrogen-sensitive diseaseReplication-deficient adenoviral vectorAnti-tumor activityStem cell antigenPC-associated antigensNoticeable antitumor activityAntibody tremelimumabExpansion doseCheckpoint inhibitorsImmunotherapy regimenAdverse events
2019
EV-103: Enfortumab vedotin plus pembrolizumab and/or chemotherapy for locally advanced or metastatic urothelial cancer.
Hoimes C, Rosenberg J, Petrylak D, Carret A, Melhem-Bertrandt A, Flaig T. EV-103: Enfortumab vedotin plus pembrolizumab and/or chemotherapy for locally advanced or metastatic urothelial cancer. Journal Of Clinical Oncology 2019, 37: tps4593-tps4593. DOI: 10.1200/jco.2019.37.15_suppl.tps4593.Peer-Reviewed Original ResearchMetastatic urothelial cancerCheckpoint inhibitorsDay 1Urothelial cancerCombination therapyMicrotubule-disrupting agent monomethyl auristatin EInvestigational antibody-drug conjugateFirst-line cisplatinPlatinum-containing regimenDisease control rateImmune checkpoint inhibitorsPhase 1b trialPhase 1 studyDuration of responseEnhanced immune responseMonomethyl auristatin EAntibody-drug conjugatesDose expansionResponse durabilityControl rateDisease progressionImmune responseAuristatin EResponse rateNectin-4
2018
Antigen-Specific CD8 Lytic Phenotype Induced by Sipuleucel-T in Hormone-Sensitive or Castration-Resistant Prostate Cancer and Association with Overall Survival
Antonarakis ES, Small EJ, Petrylak D, Quinn DI, Kibel AS, Chang NN, Dearstyne E, Harmon M, Campogan D, Haynes H, Vu T, Sheikh NA, Drake CG. Antigen-Specific CD8 Lytic Phenotype Induced by Sipuleucel-T in Hormone-Sensitive or Castration-Resistant Prostate Cancer and Association with Overall Survival. Clinical Cancer Research 2018, 24: 4662-4671. PMID: 29858218, PMCID: PMC6481607, DOI: 10.1158/1078-0432.ccr-18-0638.Peer-Reviewed Original ResearchMeSH KeywordsAcid PhosphataseCD8-Positive T-LymphocytesCell Line, TumorCell ProliferationClinical Trials as TopicGene Expression Regulation, NeoplasticGranulocyte-Macrophage Colony-Stimulating FactorHumansLysosomal-Associated Membrane Protein 1MaleNeoplasm MetastasisNeoplasms, Hormone-DependentProstatic Neoplasms, Castration-ResistantRecombinant Fusion ProteinsTissue ExtractsT-Lymphocytes, CytotoxicConceptsSipuleucel-T treatmentMetastatic castration-resistant prostate cancerProstatic acid phosphataseOverall survivalCTL activityWeek 26Immune responseWeek 6Peripheral cellular immune responsesCytotoxic T lymphocyte activityCastration-resistant prostate cancerEfficacy of sipuleucelImproved overall survivalMedian overall survivalT lymphocyte activityT cell responsesCellular immune responsesT cell proliferationClin Cancer ResHealthy volunteer samplesCD107a expressionLonger OSLymphocyte activityCytolytic responsesTertile analysisOverall 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
Sipuleucel-T (sip-T) to induce cytolytic T lymphocyte (CTL) activity against target antigens in men with hormone-sensitive and castration-resistant prostate cancer (CRPC).
Drake C, Antonarakis E, Petrylak D, Quinn D, Kibel A, Chang N, Dearstyne E, Campogan D, Haynes H, Vu T, Sheikh N, Small E. Sipuleucel-T (sip-T) to induce cytolytic T lymphocyte (CTL) activity against target antigens in men with hormone-sensitive and castration-resistant prostate cancer (CRPC). Journal Of Clinical Oncology 2017, 35: 5046-5046. DOI: 10.1200/jco.2017.35.15_suppl.5046.Peer-Reviewed Original ResearchCastration-resistant prostate cancerPeripheral blood mononuclear cellsCTL lytic activityCD107a expressionOverall survivalT cellsImmune responseSymptomatic metastatic castration-resistant prostate cancerMetastatic castration-resistant prostate cancerCytolytic T lymphocyte activityAntigen-specific cellular responsesAutologous cellular immunotherapyGreater CTL activityHealthy donor controlsRobust CTL responsesT lymphocyte activityCD8 T cellsLonger overall survivalAntigen-specific proliferationBlood mononuclear cellsHumoral immune responseLytic activityOS benefitMCRPC patientsMetastatic CRPCSipuleucel-T (sip-T) induced lytic CD8+ T cell responses to target antigens in men with hormone-sensitive and castration-resistant prostate cancer (CRPC).
Antonarakis E, Quinn D, Kibel A, Petrylak D, Vu T, Campogan D, Chang N, Trager J, Sheikh N, Drake C. Sipuleucel-T (sip-T) induced lytic CD8+ T cell responses to target antigens in men with hormone-sensitive and castration-resistant prostate cancer (CRPC). Journal Of Clinical Oncology 2017, 35: 162-162. DOI: 10.1200/jco.2017.35.7_suppl.162.Peer-Reviewed Original ResearchCastration-resistant prostate cancerT cell responsesCarboxyfluorescein succinimidyl esterProstatic acid phosphataseCTL activityCell responsesLytic abilityT cellsImmune responseProliferative responseSymptomatic metastatic castration-resistant prostate cancerAutologous peripheral blood mononuclear cellsMetastatic castration-resistant prostate cancerAntigen-specific CTL activityPeripheral blood mononuclear cellsSubset of ptsAntigen-specific CD8Vitro antigen stimulationBlood mononuclear cellsGranulocyte-macrophage colony-stimulating factorTumor cell lysisIntracellular granzyme BMononuclear blood cellsMacrophage colony-stimulating factorColony-stimulating factorCytokine profile of sipuleucel-T (sip-T) in differentiating reactivation of latent immunity from de novo immune responses.
Drake C, Petrylak D, Antonarakis E, Kibel A, Chang N, Vu T, Campogan D, Haynes H, Trager J, Sheikh N, Quinn D. Cytokine profile of sipuleucel-T (sip-T) in differentiating reactivation of latent immunity from de novo immune responses. Journal Of Clinical Oncology 2017, 35: 163-163. DOI: 10.1200/jco.2017.35.7_suppl.163.Peer-Reviewed Original ResearchMetastatic castration-resistant prostate cancerPeripheral blood mononuclear cellsProstatic acid phosphataseT cell responsesT cellsIL-2Cytokine profileImmune responseSymptomatic metastatic castration-resistant prostate cancerAutologous peripheral blood mononuclear cellsWk 6Cell responsesDe novo immune responsesCastration-resistant prostate cancerNovo immune responsesIntracellular IL-2IFN-γ levelsMemory T cellsBlood mononuclear cellsPre-existing immunityT cell proliferationGranulocyte-macrophage colony-stimulating factorCytokine release profileMacrophage colony-stimulating factorColony-stimulating factor
2016
Sipuleucel-T (sip-T)–induced proliferative CD8+ T-cell responses to immunizing and secondary antigens.
Antonarakis E, Quinn D, Kibel A, Petrylak D, Chang N, Cummings C, Chinn J, Pufnock J, Sheikh N, Drake C. Sipuleucel-T (sip-T)–induced proliferative CD8+ T-cell responses to immunizing and secondary antigens. Journal Of Clinical Oncology 2016, 34: 165-165. DOI: 10.1200/jco.2016.34.2_suppl.165.Peer-Reviewed Original ResearchT cell responsesMetastatic castration-resistant prostate cancerProstatic acid phosphataseGranulocyte macrophage-colony stimulating factorSecondary antigensProliferative CD8Immune responseSymptomatic metastatic castration-resistant prostate cancerCell responsesCastration-resistant prostate cancerPeripheral blood mononuclear cellsAntigen-specific CD8Improved overall survivalT-cell involvementCellular immune responsesT cell subpopulationsBlood mononuclear cellsTumor cell lysisMacrophage-colony stimulating factorAntigen spreadEvaluable ptsOverall survivalWeek 26Autologous immunotherapyMononuclear cells
2015
Immune response from STRIDE, a randomized, Phase II, open-label study of sipuleucel-T (sip-T) with concurrent vs sequential enzalutamide (enz) administration in metastatic castration-resistant prostate cancer (mCRPC)
Drake C, Quinn D, Dreicer R, Antonarakis E, Shore N, Corman J, Concepcion R, Pieczonka C, Campogan D, Fan L, Chang N, Sheikh N, Petrylak D. Immune response from STRIDE, a randomized, Phase II, open-label study of sipuleucel-T (sip-T) with concurrent vs sequential enzalutamide (enz) administration in metastatic castration-resistant prostate cancer (mCRPC). Journal For ImmunoTherapy Of Cancer 2015, 3: p145. PMCID: PMC4645289, DOI: 10.1186/2051-1426-3-s2-p145.Peer-Reviewed Original Research2526 Immune responses and clinical data from STRIDE, a randomized, phase 2, open label study of sipuleucel-T with concurrent vs sequential enzalutamide administration in metastatic castrationresistant prostate cancer
Petrylak D, Quinn D, Dreicer R, Antonarakis E, Shore N, Corman J, Concepcion R, Pieczonka C, Chang N, DeVries T, Sheikh N, Drake C. 2526 Immune responses and clinical data from STRIDE, a randomized, phase 2, open label study of sipuleucel-T with concurrent vs sequential enzalutamide administration in metastatic castrationresistant prostate cancer. European Journal Of Cancer 2015, 51: s483. DOI: 10.1016/s0959-8049(16)31345-4.Peer-Reviewed Original ResearchImmune response from STRIDE, a randomized, phase 2, open label study of sipuleucel-T (sip-T) with concurrent vs sequential enzalutamide (enz) administration in metastatic castration-resistant prostate cancer (mCRPC).
Quinn D, Drake C, Dreicer R, Antonarakis E, Shore N, Corman J, Concepcion R, Pieczonka C, Chang N, DeVries T, Sheikh N, Petrylak D. Immune response from STRIDE, a randomized, phase 2, open label study of sipuleucel-T (sip-T) with concurrent vs sequential enzalutamide (enz) administration in metastatic castration-resistant prostate cancer (mCRPC). Journal Of Clinical Oncology 2015, 33: 5040-5040. DOI: 10.1200/jco.2015.33.15_suppl.5040.Peer-Reviewed Original Research
2014
Myeloid cell biology and inhibition of anti-tumor immune responses by MPDL3280A in urothelial bladder cancer
Xiao Y, Rabe C, Kowanetz M, Powles T, Vogelzang N, Petrylak D, Loriot Y, Denker M, Nakamura R, Wu Q, Sumiyoshi T, Boyd Z, Teng S, Shen X, Fine G, Chen D, Hegde P. Myeloid cell biology and inhibition of anti-tumor immune responses by MPDL3280A in urothelial bladder cancer. Journal For ImmunoTherapy Of Cancer 2014, 2: p131. PMCID: PMC4288443, DOI: 10.1186/2051-1426-2-s3-p131.Peer-Reviewed Original Research774P 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
2013
Immune response with sipuleucel-T in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC): Phase II ProACT study.
Gardner T, Petrylak D, Corman J, Hall S, Weinstein R, Keyser R, Sims R, Sanders A, Sheikh N, Higano C. Immune response with sipuleucel-T in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC): Phase II ProACT study. Journal Of Clinical Oncology 2013, 31: 148-148. DOI: 10.1200/jco.2013.31.6_suppl.148.Peer-Reviewed Original ResearchMetastatic castration-resistant prostate cancerSymptomatic metastatic castration-resistant prostate cancerMemory B cellsImmune responseOverall survivalB cellsOngoing phase 2 studyCastration-resistant prostate cancerAutologous cellular immunotherapyPeripheral immune responsePhase 2 studyProlongs overall survivalST infusionCellular immunotherapySerum antiMemory phenotypeSipuleucelPA2024Prostate cancerCSF titersActivation phenotypeAnti-GMGM-CSFFlow cytometryMature phenotype
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