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 therapyFirst-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
2019
Mature results from EV-101: A phase I study of enfortumab vedotin in patients with metastatic urothelial cancer (mUC).
Rosenberg J, Sridhar S, Zhang J, Smith D, Ruether J, Flaig T, Baranda J, Lang J, Plimack E, Sangha R, Heath E, Merchan J, Quinn D, Srinivas S, Milowsky M, Wu C, Gartner E, Melhem-Bertrandt A, Petrylak D. Mature results from EV-101: A phase I study of enfortumab vedotin in patients with metastatic urothelial cancer (mUC). Journal Of Clinical Oncology 2019, 37: 377-377. DOI: 10.1200/jco.2019.37.7_suppl.377.Peer-Reviewed Original ResearchMetastatic urothelial cancerTreatment-related AEsLiver metastasesMedian followUrothelial cancerPrimary tumor siteUnmet medical needMedian PFSPrior chemotherapyMonotherapy studiesMedian durationPoor prognosisCombination therapyPlatinum chemotherapyMature resultsDay 1Nectin-4Medical needTumor siteSecondary objectivePhase IAntitumor activityEncouraging responseSurvival dataChemotherapy
2018
Pembrolizumab (pembro) versus investigator’s choice (paclitaxel, docetaxel, or vinflunine) in recurrent, advanced urothelial cancer (UC): 2-year follow-up from the phase 3 KEYNOTE-045 trial.
Fradet Y, Bellmunt J, De Wit R, Vaughn D, Lee J, Fong L, Vogelzang N, Climent M, Petrylak D, Choueiri T, Necchi A, Gerritsen W, Gurney H, Quinn D, Culine S, Sternberg C, Nam K, Frenkl T, Perini R, Bajorin D. Pembrolizumab (pembro) versus investigator’s choice (paclitaxel, docetaxel, or vinflunine) in recurrent, advanced urothelial cancer (UC): 2-year follow-up from the phase 3 KEYNOTE-045 trial. Journal Of Clinical Oncology 2018, 36: 4521-4521. DOI: 10.1200/jco.2018.36.15_suppl.4521.Peer-Reviewed Original ResearchMetastatic urothelial cancerUrothelial cancerInvestigator's choiceAdverse eventsPrimary efficacy end pointTreatment-related adverse eventsEnd pointAdvanced urothelial cancerPlatinum-containing regimenEfficacy end pointSecondary end pointsKaplan-Meier methodPlatinum-based chemotherapyRisk factor groupsBaseline hemoglobinECOG PSMedian OSOS benefitPrior therapyEligible patientsLiver metastasesMedian durationPembroInterim analysisExpression subgroupsTwo-year follow-up from the phase 3 KEYNOTE-045 trial of pembrolizumab (pembro) vs investigator’s choice (paclitaxel, docetaxel, or vinflunine) in recurrent, advanced urothelial cancer (UC).
Bellmunt J, De Wit R, Vaughn D, Fradet Y, Lee J, Fong L, Vogelzang N, Climent M, Petrylak D, Choueiri T, Necchi A, Gerritsen W, Gurney H, Quinn D, Culine S, Sternberg C, Nam K, Frenkl T, Perini R, Bajorin D. Two-year follow-up from the phase 3 KEYNOTE-045 trial of pembrolizumab (pembro) vs investigator’s choice (paclitaxel, docetaxel, or vinflunine) in recurrent, advanced urothelial cancer (UC). Journal Of Clinical Oncology 2018, 36: 410-410. DOI: 10.1200/jco.2018.36.6_suppl.410.Peer-Reviewed Original ResearchMetastatic urothelial cancerUrothelial cancerInvestigator's choiceAdverse eventsPrimary efficacy end pointTreatment-related adverse eventsEnd pointAdvanced urothelial cancerPlatinum-containing regimenEfficacy end pointSecondary end pointsKaplan-Meier methodPlatinum-based chemotherapyRisk factor groupsECOG PSBaseline hemoglobinEligible patientsMedian OSOS benefitPrior therapyMedian durationLiver metastasesPembroInterim analysisExpression subgroups
2017
Planned survival analysis from KEYNOTE-045: Phase 3, open-label study of pembrolizumab (pembro) versus paclitaxel, docetaxel, or vinflunine in recurrent, advanced urothelial cancer (UC).
Bajorin D, De Wit R, Vaughn D, Fradet Y, Lee J, Fong L, Vogelzang N, Climent M, Petrylak D, Choueiri T, Necchi A, Gerritsen W, Gurney H, Quinn D, Culine S, Sternberg C, Mai Y, Puhlmann M, Perini R, Bellmunt J. Planned survival analysis from KEYNOTE-045: Phase 3, open-label study of pembrolizumab (pembro) versus paclitaxel, docetaxel, or vinflunine in recurrent, advanced urothelial cancer (UC). Journal Of Clinical Oncology 2017, 35: 4501-4501. DOI: 10.1200/jco.2017.35.15_suppl.4501.Peer-Reviewed Original ResearchAdvanced urothelial cancerUrothelial cancerSurvival analysisPrimary efficacy end pointEnd pointECOG PS 0Efficacy end pointSecond-line chemotherapyTreatment-related AEsOpen-label studySecondary end pointsPD-L1 expressionSuperior safety profileECOG PSKEYNOTE-045Measurable diseaseOS benefitMedian OSPrior therapyBaseline characteristicsLonger OSMedian durationPS 0Systemic therapyLiver metastasesA 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
2014
808O Inhibition of Pd-L1 By Mpdl3280A Leads to Clinical Activity in Pts with Metastatic Urothelial Bladder Cancer (Ubc)
Bellmunt J, Petrylak D, Powles T, Braiteh F, Vogelzang N, Cruz C, Burris H, Eder J, Fine G, Teng M, Shen X, Bruey J, Boyd Z, Hegde P, Chen D, Loriot Y. 808O Inhibition of Pd-L1 By Mpdl3280A Leads to Clinical Activity in Pts with Metastatic Urothelial Bladder Cancer (Ubc). Annals Of Oncology 2014, 25: iv280. DOI: 10.1093/annonc/mdu337.1.Peer-Reviewed Original ResearchMedian durationPD-L1Metastatic urothelial bladder cancerCaris Life SciencesClinical cutoff dateDrug-related AEsECOG PS 1Employees of GenentechPD-L1 statusPD-L1 expressionPoor prognostic factorReceptor PD-1Urothelial bladder cancerPD-L1 IHCPD-L1 bindingEvaluable ptsIHC 0/1Median DoRPrior chemoPrior cisplatinPrior therapyRECIST v1.1Visceral metastasesLiver metastasesObjective response
2006
Intermittent chemotherapy in metastatic androgen-independent prostate cancer (AIPC): Initial results from ASCENT
Beer T, Ryan C, Venner P, Petrylak D, Chatta G, Ruether J, Chi K, Arroyo A, Clow F. Intermittent chemotherapy in metastatic androgen-independent prostate cancer (AIPC): Initial results from ASCENT. Journal Of Clinical Oncology 2006, 24: 4518-4518. DOI: 10.1200/jco.2006.24.18_suppl.4518.Peer-Reviewed Original ResearchAndrogen-independent prostate cancerMetastatic androgen-independent prostate cancerMulti-institutional trialSerum PSAIntermittent chemotherapyChemotherapy holidayTreatment holidayDN-101Large multi-institutional trialsOverall PSA response rateDocetaxel-containing chemotherapyFirst large trialPSA response rateResumption of treatmentPhase III studyMinority of patientsPhase II dataStable PSASame regimenIII studyMedian durationMost patientsSurvival benefitLarge trialsPSA values
2000
DEXAMETHASONE DOES NOT SIGNIFICANTLY CONTRIBUTE TO THE RESPONSE RATE OF DOCETAXEL AND ESTRAMUSTINE IN ANDROGEN INDEPENDENT PROSTATE CANCER
WEITZMAN A, SHELTON G, ZUECH N, OWEN C, JUDGE T, BENSON M, SAWCZUK I, KATZ A, OLSSON C, BAGIELLA E, PFAFF C, NEWHOUSE J, PETRYLAK D. DEXAMETHASONE DOES NOT SIGNIFICANTLY CONTRIBUTE TO THE RESPONSE RATE OF DOCETAXEL AND ESTRAMUSTINE IN ANDROGEN INDEPENDENT PROSTATE CANCER. Journal Of Urology 2000, 163: 834-837. PMID: 10687988, DOI: 10.1016/s0022-5347(05)67815-9.Peer-Reviewed Original ResearchConceptsProstate-specific antigenAndrogen-independent prostate cancerIndependent prostate cancerResponse rateMedian timeProstate cancerBaseline prostate-specific antigenSerum prostate-specific antigenMedian PSA increasePSA response rateDexamethasone monotherapyEstramustine administrationPSA declineMedian durationPartial responsePSA increaseDisease 3Day 1Specific antigenWeek 9Day 2EstramustinePatientsDocetaxelDexamethasone
1992
Estramustine and Vinblastine: Use of Prostate Specific Antigen as a Clinical Trial End Point for Hormone Refractory Prostatic Cancer
Seidman A, Scher H, Petrylak D, Dershaw D, Curley T. Estramustine and Vinblastine: Use of Prostate Specific Antigen as a Clinical Trial End Point for Hormone Refractory Prostatic Cancer. Journal Of Urology 1992, 147: 931-934. PMID: 1371564, DOI: 10.1016/s0022-5347(17)37426-8.Peer-Reviewed Original ResearchConceptsHormone-refractory prostatic cancerProstatic cancerProgressive hormone-refractory prostate cancerElevated prostate-specific antigen levelsProstate-specific antigen levelHormone-refractory prostate cancerClinical trial end pointsOutpatient treatment regimenRefractory prostate cancerSpecific antigen levelsTrial end pointsProstate-specific antigenManageable toxicityMedian durationPartial responsePSA levelsTreatment regimenEstramustine phosphateAntigen levelsProstate cancerAdditive cytotoxicityMedian decreasePatientsSpecific antigenHuman prostate