2023
First-in-class oral innate immune activator BXCL701 combined with pembrolizumab in patients with metastatic, castration-resistant prostate cancer (mCRPC) of small cell neuroendocrine (SCNC) phenotype: Phase 2a final results.
Aggarwal R, Zhang J, Zhu X, Monk P, Jones R, Linch M, Costin D, De Bono J, Karsh L, Petrylak D, Borderies P, Deshpande R, Hafeez A, O'Neill V, Tagawa S. First-in-class oral innate immune activator BXCL701 combined with pembrolizumab in patients with metastatic, castration-resistant prostate cancer (mCRPC) of small cell neuroendocrine (SCNC) phenotype: Phase 2a final results. Journal Of Clinical Oncology 2023, 41: 176-176. DOI: 10.1200/jco.2023.41.6_suppl.176.Peer-Reviewed Original ResearchEvaluable patientsMedian durationDay 1Castration-resistant prostate cancerOral small-molecule inhibitorEncouraging anti-tumor activityImmune-related AEPrime immune cellsAcceptable safety profilePhase 2 studyDurability of responsePlatinum-based chemotherapyImmune effector cellsStandard of careAnti-tumor activityComposite respondersRECIST respondersBID dosingCheckpoint inhibitorsMCRPC patientsPrimary endpointRECIST 1.1Acceptable tolerabilityAdverse eventsCytotoxic chemotherapy
2022
BXCL701: First-in-class oral activator of systemic innate immunity combined with pembrolizumab, in patients with metastatic castration-resistant prostate cancer (mCRPC) of small-cell neuroendocrine carcinoma (SCNC) phenotype—Phase 2a interim results.
Tagawa S, Zhang J, Monk P, Zhu X, Jones R, Linch M, Costin D, De Bono J, Karsh L, Petrylak D, Borderies P, Deshpande R, O'Neill V, Aggarwal R. BXCL701: First-in-class oral activator of systemic innate immunity combined with pembrolizumab, in patients with metastatic castration-resistant prostate cancer (mCRPC) of small-cell neuroendocrine carcinoma (SCNC) phenotype—Phase 2a interim results. Journal Of Clinical Oncology 2022, 40: 126-126. DOI: 10.1200/jco.2022.40.6_suppl.126.Peer-Reviewed Original ResearchSmall cell neuroendocrine carcinomaMetastatic castration-resistant prostate cancerEvaluable patientsAnti-tumor activityPrior linesCastration-resistant prostate cancerOral small-molecule inhibitorEncouraging anti-tumor activityBone-only diseaseComposite response rateImmune-related AEPhase 1b/2 studyPrime immune cellsSystemic innate immunityAcceptable safety profileImmune effector cellsStandard of careInterim resultsStage 1Prior chemotherapyRECIST 1.1Unconfirmed PRBID dosingCheckpoint inhibitorsMCRPC patients
2020
Safety and clinical activity of atezolizumab (atezo) + radium-223 dichloride (r-223) in 2L metastatic castration-resistant prostate cancer (mCRPC): Results from a phase Ib clinical trial.
Morris M, Fong L, Petrylak D, Sartor A, Higano C, Pagliaro L, Alva A, Appleman L, Tan W, Vaishampayan U, Porcu R, Tayama D, Kadel E, Yuen K, Datye A, Armstrong A. Safety and clinical activity of atezolizumab (atezo) + radium-223 dichloride (r-223) in 2L metastatic castration-resistant prostate cancer (mCRPC): Results from a phase Ib clinical trial. Journal Of Clinical Oncology 2020, 38: 5565-5565. DOI: 10.1200/jco.2020.38.15_suppl.5565.Peer-Reviewed Original ResearchMetastatic castration-resistant prostate cancerPSA response ratePSA progressionDosing schedulesPD-L1Clinical benefitResponse ratePD-1/PD-L1Castration-resistant prostate cancerPhase Ib clinical trialPhase 1b studyPhase Ib studyTumor-directed radiationAnti-tumor immunityDose-limiting toxicityRadium-223 dichlorideLimited treatment optionsMechanism of actionEvaluable ptsRadiographic PFSMCRPC patientsMedian OSBaseline characteristicsEvaluable dataUnacceptable toxicity
2019
Genomic characteristics of deleterious BRCA1 and BRCA2 alterations and associations with baseline clinical factors in patients with metastatic castration-resistant prostate cancer (mCRPC) enrolled in TRITON2.
Abida W, Bryce A, Vogelzang N, Amato R, Percent I, Shapiro J, McDermott R, Hussain A, Patnaik A, Petrylak D, Ryan C, Stanton T, Zhang J, Loehr A, Simmons A, Despain D, Golsorkhi A, Watkins S, Scher H, Chowdhury S. Genomic characteristics of deleterious BRCA1 and BRCA2 alterations and associations with baseline clinical factors in patients with metastatic castration-resistant prostate cancer (mCRPC) enrolled in TRITON2. Journal Of Clinical Oncology 2019, 37: 5031-5031. DOI: 10.1200/jco.2019.37.15_suppl.5031.Peer-Reviewed Original ResearchMetastatic castration-resistant prostate cancerBaseline clinical characteristicsDNA damage repair genesClinical characteristicsBRCA1 patientsProstate-specific antigen levelCastration-resistant prostate cancerBaseline clinical factorsMeasurable tumor burdenDeleterious alterationsGenomic alterationsCo-occurring alterationsRepair genesNext-generation sequencing assayBRCA alterationsMCRPC patientsBaseline PSAPSA levelsClinical factorsTumor burdenDeleterious germlineAntigen levelsBRCA mutationsBRCA2 alterationsDeleterious BRCA1
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 CRPC