2023
First-in-human, phase 1 study of PF-06753512, a vaccine-based immunotherapy regimen (VBIR), in non-metastatic hormone-sensitive biochemical recurrence 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, Madan R, Billotte S, Cavazos N, Bogg O, Li R, Chan K, Cho H, Kaneda M, Wang I, Zheng J, Tang S, Hollingsworth R, Kern K, Petrylak D. First-in-human, phase 1 study of PF-06753512, a vaccine-based immunotherapy regimen (VBIR), in non-metastatic hormone-sensitive biochemical recurrence and metastatic castration-resistant prostate cancer (mCRPC). Journal For ImmunoTherapy Of Cancer 2023, 11: e005702. PMID: 36948505, PMCID: PMC10040068, DOI: 10.1136/jitc-2022-005702.Peer-Reviewed Original ResearchConceptsMetastatic castration-resistant prostate cancerAndrogen deprivation therapyRadiographic progression-free survivalCastration-resistant prostate cancerPhase 1 studyBiochemical recurrenceProstate cancerImmunotherapy regimenMedian durationDose escalationMedian radiographic progression-free survivalAntigen-specific T cell responsesImmune-related adverse eventsRecommended phase 2 doseSpecific T cell responsesPhase 2 doseImmune checkpoint inhibitorsModest antitumor activityObjective response rateProgression-free survivalAntigen-specific immunityT cell responsesInfluenza-like illnessSignificant side effectsDeprivation therapy
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 ProteinsT-Lymphocytes, CytotoxicTissue ExtractsConceptsSipuleucel-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 analysis
2017
Sipuleucel-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 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, Cummings C, Trager J, Chinn 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 2016, 34: e23116-e23116. DOI: 10.1200/jco.2016.34.15_suppl.e23116.Peer-Reviewed Original ResearchSipuleucel-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