2023
EV-301 long-term outcomes: 24-month findings from the phase III trial of enfortumab vedotin versus chemotherapy in patients with previously treated advanced urothelial carcinoma☆
Rosenberg J, Powles T, Sonpavde G, Loriot Y, Duran I, Lee J, Matsubara N, Vulsteke C, Castellano D, Mamtani R, Wu C, Matsangou M, Campbell M, Petrylak D. EV-301 long-term outcomes: 24-month findings from the phase III trial of enfortumab vedotin versus chemotherapy in patients with previously treated advanced urothelial carcinoma☆. Annals Of Oncology 2023, 34: 1047-1054. PMID: 37678672, DOI: 10.1016/j.annonc.2023.08.016.Peer-Reviewed Original ResearchConceptsProgression-free survivalEnfortumab vedotinAdverse eventsUrothelial carcinomaTreatment-related adverse event ratesMeaningful overall survival benefitPrior platinum-containing chemotherapyWhite blood cell countEvent ratesAdvanced urothelial carcinomaMetastatic urothelial carcinomaOverall survival benefitPeripheral sensory neuropathyPlatinum-containing chemotherapyNew safety signalsPhase III trialsAdverse event ratesRisk of deathBlood cell countIII trialsMaculopapular rashNeutrophil countObjective responseOverall survivalSurvival benefit
2021
BXCL701, first-in-class oral activator of systemic innate immunity pathway, combined with pembrolizumab (Keytruda) in men with metastatic castration-resistant prostate cancer (mCRPC).
Aggarwal R, Costin D, Zhang J, Karsh L, Healey D, Linch M, Adurthi S, Petrylak D, O'Neill V, Monk P. BXCL701, first-in-class oral activator of systemic innate immunity pathway, combined with pembrolizumab (Keytruda) in men with metastatic castration-resistant prostate cancer (mCRPC). Journal Of Clinical Oncology 2021, 39: 124-124. DOI: 10.1200/jco.2021.39.6_suppl.124.Peer-Reviewed Original ResearchMetastatic castration-resistant prostate cancerTotal daily doseAdverse eventsPhase 2 portionObjective responseImproved tolerabilityAnti-PD-1/PD-L1Day 1Serum IL-18 levelsCastration-resistant prostate cancerOral small-molecule inhibitorDipeptidyl peptidasePreliminary anti-tumor activityPhase 2 doseAndrogen deprivation therapyCytokine release syndromeStage IV melanomaIL-18 levelsPD-L1 expressionSignificant tumor growth inhibitionLower extremity edemaImmune effector cellsPrior clinical studiesTarget adverse eventsProstate cancer phenotypeEfficacy of enzalutamide (ENZA) plus androgen deprivation therapy (ADT) in men with de novo (M1) metastatic hormone-sensitive prostate cancer (mHSPC) versus progression to mHSPC (M0): Post hoc analysis of the phase III ARCHES trial.
Azad A, Villers A, Alekseev B, Szmulewitz R, Alcaraz A, Shore N, Petrylak D, Holzbeierlein J, Gomez-Veiga F, Rosbrook B, Zohren F, Lee H, Haas G, Iguchi T, Stenzl A, Armstrong A. Efficacy of enzalutamide (ENZA) plus androgen deprivation therapy (ADT) in men with de novo (M1) metastatic hormone-sensitive prostate cancer (mHSPC) versus progression to mHSPC (M0): Post hoc analysis of the phase III ARCHES trial. Journal Of Clinical Oncology 2021, 39: 102-102. DOI: 10.1200/jco.2021.39.6_suppl.102.Peer-Reviewed Original ResearchMetastatic hormone-sensitive prostate cancerEfficacy of enzalutamideAndrogen deprivation therapyDe novo metastatic hormone-sensitive prostate cancerM1 diseaseInitial diagnosisProstate-specific antigenSecondary endpointsDisease volumeTreatment armsHormone-sensitive prostate cancerProgression-free survival eventsPrior docetaxel useKey secondary endpointNew antineoplastic therapiesDeprivation therapyDocetaxel usePrior docetaxelEfficacy outcomesPrimary endpointPSA progressionBaseline characteristicsObjective responseClinical benefitSafety profileSapanisertib, a dual mTORC1/2 inhibitor, for TSC1- or TSC2- mutated metastatic urothelial carcinoma (mUC).
Kim J, Milowsky M, Hahn N, Kwiatkowski D, Morgans A, Davis N, Appleman L, Gupta S, Lara P, Hoffman-Censits J, Quinn D, Shyr Y, LoRusso P, Sklar J, Petrylak D. Sapanisertib, a dual mTORC1/2 inhibitor, for TSC1- or TSC2- mutated metastatic urothelial carcinoma (mUC). Journal Of Clinical Oncology 2021, 39: 431-431. DOI: 10.1200/jco.2021.39.6_suppl.431.Peer-Reviewed Original ResearchMetastatic urothelial carcinomaStable diseaseAdverse eventsObjective responseWithdrew consentTSC2 mutationsUrothelial carcinomaTSC1 mutationsTumor samplesCommon adverse eventsMedian overall survivalTreatment-related deathsPhase II studyCentral labOverall response rateDual mTORC1/2 inhibitorUnknown mutational statusCentral confirmationEligible patientsEvaluable patientsMUC patientsRestaging scanII studyPrimary endpointBaseline characteristics
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
2012
A phase III, randomized, double-blind, multicenter trial comparing the investigational agent orteronel (TAK-700) plus prednisone (P) with placebo plus P in patients with metastatic castration-resistant prostate cancer (mCRPC) that has progressed during or following docetaxel-based therapy.
Dreicer R, Agus D, Bellmunt J, De Bono J, Petrylak D, Tejura B, Shi Y, Fizazi K. A phase III, randomized, double-blind, multicenter trial comparing the investigational agent orteronel (TAK-700) plus prednisone (P) with placebo plus P in patients with metastatic castration-resistant prostate cancer (mCRPC) that has progressed during or following docetaxel-based therapy. Journal Of Clinical Oncology 2012, 30: tps4693-tps4693. DOI: 10.1200/jco.2012.30.15_suppl.tps4693.Peer-Reviewed Original ResearchMetastatic castration-resistant prostate cancerDisease progressionRadiographic progression-free survivalProstate-specific antigen levelCastration-resistant prostate cancerChemotherapy-naïve menDocetaxel-based therapyPhase 1/2 studyPhase 3 studyProgression-free survivalPatient-reported outcomesNew therapeutic optionsTestosterone synthesis pathwayERG fusion geneBone painMedical castrationNoncurative therapyHormonal therapyPrimary endpointPSA decreasePSA progressionStudy drugMetastatic diseaseObjective responseOverall survival
2000
A Phase II Pilot Study of KW-2189 in Patients with Advanced Renal Cell Carcinoma
Small E, Figlin R, Petrylak D, Vaughn D, Sartor O, Horak I, Pincus R, Kremer A, Bowden C. A Phase II Pilot Study of KW-2189 in Patients with Advanced Renal Cell Carcinoma. Investigational New Drugs 2000, 18: 193-198. PMID: 10857997, DOI: 10.1023/a:1006386115312.Peer-Reviewed Original ResearchConceptsRenal cell carcinomaMetastatic renal cell carcinomaCell carcinomaOpen-label phase II trialCommon drug-related toxicitiesAdvanced renal cell carcinomaPhase II pilot studyNon-hematologic toxicitiesPhase II trialDrug-related toxicityPredictable safety profileReversible myelosuppressionII trialObjective responseSafety profileDisease progressionModerate fatigueWeek 6PatientsSignificant toxicityCarcinomaPilot studyAntitumor potencyWater-soluble analogueCycle 1
1993
CYTOTOXIC CHEMOTHERAPY FOR ADVANCED RENAL CELL CARCINOMA
Yagoda A, Petrylak D, Thompson S. CYTOTOXIC CHEMOTHERAPY FOR ADVANCED RENAL CELL CARCINOMA. Urologic Clinics Of North America 1993, 20: 303-321. PMID: 8493752, DOI: 10.1016/s0094-0143(21)00489-4.Peer-Reviewed Original ResearchCytotoxic chemotherapy for advanced hormone‐resistant prostate cancer
Yagoda A, Petrylak D. Cytotoxic chemotherapy for advanced hormone‐resistant prostate cancer. Cancer 1993, 71: 1098-1109. PMID: 7679039, DOI: 10.1002/1097-0142(19930201)71:3+<1098::aid-cncr2820711432>3.0.co;2-g.Peer-Reviewed Original ResearchMeSH KeywordsAntibodies, MonoclonalAntineoplastic AgentsBone NeoplasmsCisplatinClinical Trials as TopicCoumarinsDoxorubicinDrug Administration ScheduleDrug ResistanceFluorouracilHumansIntercalating AgentsMaleMethotrexateNeoplasm StagingPolyaminesProstate-Specific AntigenProstatic NeoplasmsRemission InductionSomatostatinConceptsDrug trialsAdvanced hormone-resistant prostate cancerHormone-resistant prostate cancerObjective response rateCombination of vinblastineMost cytotoxic agentsReliable disease markersNew drug trialsProstate cancer cellsCurrent reviewNew therapeutic agentsPartial remissionVisceral metastasesAdvanced adenocarcinomaCytotoxic chemotherapyObjective responseContinuous infusionNonresponsive tumorsMarginal efficacyHormonal manipulationProstate cancerNew agentsResponse rateCytotoxic drugsTherapeutic agents