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) variant: Randomized phase 2b trial.
Aggarwal R, Zhang J, Monk P, Zhu X, Costin D, 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) variant: Randomized phase 2b trial. Journal Of Clinical Oncology 2023, 41: tps5109-tps5109. DOI: 10.1200/jco.2023.41.16_suppl.tps5109.Peer-Reviewed Original ResearchMetastatic castration-resistant prostate cancerSerious adverse eventsPartial responsePrimary endpointPhase 2aRandomized Phase 2b TrialCastration-resistant prostate cancerOral small-molecule inhibitorPhase 2b trialPrime immune cellsRECIST 1.1 criteriaDisease control rateImmune checkpoint inhibitorsPhase 2 studyPlatinum-based chemotherapyDuration of responsePotential predictive biomarkersImmune effector cellsMeasurable diseaseNeuroendocrine variantPSA-PFSRECIST 1.1Safety populationCheckpoint inhibitorsData cutoff
2022
BXCL701: First-in-class oral activator of systemic innate immunity combined with pembrolizumab, in patients with metastatic castration-resistant prostate cancer (mCRPC) of adenocarcinoma phenotype—Phase 2a results.
Zhang J, Aggarwal R, Tagawa S, Linch M, Petrylak D, Costin D, De Bono J, Jones R, Karsh L, Zhu X, Borderies P, Deshpande R, O'Neill V, Monk P. BXCL701: First-in-class oral activator of systemic innate immunity combined with pembrolizumab, in patients with metastatic castration-resistant prostate cancer (mCRPC) of adenocarcinoma phenotype—Phase 2a results. Journal Of Clinical Oncology 2022, 40: 125-125. DOI: 10.1200/jco.2022.40.6_suppl.125.Peer-Reviewed Original ResearchMetastatic castration-resistant prostate cancerAnti-tumor activityEvaluable patientsTaxane chemotherapyPrior linesAndrogen receptorProstate cancerAdenocarcinoma cohortCastration-resistant prostate cancerOral small-molecule inhibitorEncouraging anti-tumor activityBone-only diseaseComposite response rateImmune-related AEPhase 1b/2 studyPrime immune cellsSystemic innate immunityDisease control rateAcceptable safety profileMost prostate cancersAndrogen deprivation treatmentImmune effector cellsCTC conversionMeasurable diseaseRECIST 1.1Impact of primary tumor location on efficacy and safety of pembrolizumab (pembro) in patients (pts) with locally advanced or metastatic urothelial carcinoma (UC) enrolled in the phase 2 KEYNOTE-052 and phase 3 KEYNOTE-045 trials.
O'Donnell P, Balar A, Castellano D, De Wit R, Vaughn D, Powles T, Vuky J, Lee J, Fradet Y, Bellmunt J, Fong L, Petrylak D, Gerritsen W, Quinn D, Culine S, Bajorin D, Xu J, Imai K, Moreno B, Grivas P. Impact of primary tumor location on efficacy and safety of pembrolizumab (pembro) in patients (pts) with locally advanced or metastatic urothelial carcinoma (UC) enrolled in the phase 2 KEYNOTE-052 and phase 3 KEYNOTE-045 trials. Journal Of Clinical Oncology 2022, 40: 516-516. DOI: 10.1200/jco.2022.40.6_suppl.516.Peer-Reviewed Original ResearchMetastatic urothelial carcinomaPrimary tumor locationKEYNOTE-045KEYNOTE-052Urothelial carcinomaTumor locationRECIST v1.1Primary tumorSafety of pembrolizumabSimilar clinical activityWithdrawal of consentMeasurable diseaseData cutoffManageable safetyUnacceptable toxicitySystemic therapyPD-L1Positive tumorsRenal pelvisDisease progressionPembroSimilar efficacyClinical activityGrade 3UT group
2021
Pembrolizumab (pembro) versus investigator’s choice of paclitaxel, docetaxel, or vinflunine in recurrent, advanced urothelial cancer (UC): 5-year follow-up from the phase 3 KEYNOTE-045 trial.
Bellmunt J, Necchi A, De Wit R, Lee J, Fong L, Vogelzang N, Durán M, Petrylak D, Choueiri T, Gerritsen W, Gurney H, Quinn D, Culine S, Sternberg C, Xu J, Moreno B, Godwin J, Bajorin D, Vaughn D, Fradet Y. Pembrolizumab (pembro) versus investigator’s choice of paclitaxel, docetaxel, or vinflunine in recurrent, advanced urothelial cancer (UC): 5-year follow-up from the phase 3 KEYNOTE-045 trial. Journal Of Clinical Oncology 2021, 39: 4532-4532. DOI: 10.1200/jco.2021.39.15_suppl.4532.Peer-Reviewed Original ResearchDuration of responseMetastatic urothelial cancerUrothelial cancerKEYNOTE-045Median OSOS benefitInvestigator's choiceKey secondary end pointMedian DOREnd pointAdvanced urothelial cancerECOG PS 0Platinum-containing regimenPrimary end pointSecondary end pointsTreatment-related AEsPhase 3 trialYears of therapyRECIST v1.1Baseline hemoglobinECOG PSMeasurable diseaseOS ratesPrior therapyData cutoffCheckMate 9KD cohort A1 final analysis: Nivolumab (NIVO) + rucaparib for post-chemotherapy (CT) metastatic castration-resistant prostate cancer (mCRPC).
Pachynski R, Retz M, Goh J, Burotto M, Gravis G, Castellano D, Flechon A, Zschaebitz S, Shaffer D, Limon J, Grimm M, McCune S, Amin N, Li J, Wang X, Unsal-Kacmaz K, Saad F, Petrylak D, Fizazi K. CheckMate 9KD cohort A1 final analysis: Nivolumab (NIVO) + rucaparib for post-chemotherapy (CT) metastatic castration-resistant prostate cancer (mCRPC). Journal Of Clinical Oncology 2021, 39: 5044-5044. DOI: 10.1200/jco.2021.39.15_suppl.5044.Peer-Reviewed Original ResearchMetastatic castration-resistant prostate cancerTreatment-related AEsObjective response rateRadiographic progression-free survivalCohorts A1Overall survivalDisease progression/unacceptable toxicityProstate-specific antigen (PSA) response rateResponse rateProgression/unacceptable toxicityCastration-resistant prostate cancerNovel hormonal therapiesSecondary efficacy resultsProgression-free survivalNew safety signalsPhase 2 trialPD-L1 upregulationPlausible therapeutic strategyPARP inhibitor treatmentMeasurable diseaseVisceral metastasesHormonal therapySecondary endpointsUnacceptable toxicityEvaluable tumorsCheckMate 9KD Arm B final analysis: Efficacy and safety of nivolumab plus docetaxel for chemotherapy-naïve metastatic castration-resistant prostate cancer.
Fizazi K, González Mella P, Castellano D, Minatta J, Rezazadeh A, Shaffer D, Vazquez Limon J, Sánchez López H, Armstrong A, Horvath L, Dzik C, Amin N, Li J, Unsal-Kacmaz K, Retz M, Saad F, Petrylak D, Pachynski R. CheckMate 9KD Arm B final analysis: Efficacy and safety of nivolumab plus docetaxel for chemotherapy-naïve metastatic castration-resistant prostate cancer. Journal Of Clinical Oncology 2021, 39: 12-12. DOI: 10.1200/jco.2021.39.6_suppl.12.Peer-Reviewed Original ResearchMetastatic castration-resistant prostate cancerTreatment-related AEsObjective response rateChemotherapy-naïve metastatic castration-resistant prostate cancerRadiographic progression-free survivalCastration-resistant prostate cancerMeasurable diseaseOverall survivalArm BProstate cancerMedian numberChemotherapy-naive metastatic castration-resistant prostate cancerDisease progression/unacceptable toxicityProstate-specific antigen (PSA) response rateResponse rateComparable objective response rateOngoing androgen deprivation therapyProgression/unacceptable toxicityImmune-related AESafety of nivolumabTreatment-related deathsAndrogen deprivation therapyPhase 2 trialProgression-free survivalAntitumor immune response
2020
Study EV-103: New randomized cohort testing enfortumab vedotin as monotherapy or in combination with pembrolizumab in locally advanced or metastatic urothelial cancer.
Mar N, Friedlander T, Hoimes C, Flaig T, Bilen M, Balar A, Henry E, Srinivas S, Rosenberg J, Petrylak D, Burgess E, Merchan J, Tagawa S, Carret A, Steinberg J, Chaney M, Milowsky M. Study EV-103: New randomized cohort testing enfortumab vedotin as monotherapy or in combination with pembrolizumab in locally advanced or metastatic urothelial cancer. Journal Of Clinical Oncology 2020, 38: tps5092-tps5092. DOI: 10.1200/jco.2020.38.15_suppl.tps5092.Peer-Reviewed Original ResearchPD-1/PD-L1 inhibitorsPlatinum-containing chemotherapyMetastatic urothelial cancerPD-L1 inhibitorsRECIST v1.1Investigator assessmentUrothelial cancerMicrotubule-disrupting agent monomethyl auristatin EDay 1PD-1 inhibitor pembrolizumabActive CNS metastasesCisplatin-containing therapyFirst-line patientsPrior systemic treatmentPD-L1 statusTumor response rateMonomethyl auristatin EAntibody-drug conjugatesMeasurable diseaseCNS metastasisPrimary endpointSecondary endpointsCreatinine clearanceSystemic treatmentUncontrolled diabetes
2019
LBA52 Efficacy and safety of nivolumab in combination with docetaxel in men with metastatic castration-resistant prostate cancer in CheckMate 9KD
Fizazi K, Mella P, Castellano D, Minatta J, Kalebasty A, Shaffer D, Limon J, Armstrong A, Lopez H, Sharkey B, Saci A, Li J, Wang X, Ciprotti M, Sathyanarayana P, Saad F, Petrylak D, Retz M, Pachynski R, Drake C. LBA52 Efficacy and safety of nivolumab in combination with docetaxel in men with metastatic castration-resistant prostate cancer in CheckMate 9KD. Annals Of Oncology 2019, 30: v885-v886. DOI: 10.1093/annonc/mdz394.045.Peer-Reviewed Original ResearchMetastatic castration-resistant prostate cancerRadiographic progression-free survivalObjective response rateCastration-resistant prostate cancerBristol-Myers SquibbGenentech/RocheAssociation of biomarkersPersonal feesMeasurable diseaseProstate cancerGrade 3/4 treatment-related adverse eventsMedian radiographic progression-free survivalProstate-specific antigen (PSA) response rateResponse rateOngoing androgen deprivation therapyTreatment-related adverse eventsSafety of nivolumabAndrogen deprivation therapyPhase II studyPhase III trialsProgression-free survivalSanofi-AventisInterim analysis resultsMedical writing assistanceNon-financial supportPSA decline and objective response rates in White (W), Black (B), and Asian men with metastatic castration-resistant prostate cancer (mCRPC).
Halabi S, Dutta S, Chi K, Tangen C, Xuan M, Petrylak D, Araujo J, Fizazi K, Quinn D, Morris M, Higano C, Tannock I, Small E, Kelly W. PSA decline and objective response rates in White (W), Black (B), and Asian men with metastatic castration-resistant prostate cancer (mCRPC). Journal Of Clinical Oncology 2019, 37: 5021-5021. DOI: 10.1200/jco.2019.37.15_suppl.5021.Peer-Reviewed Original ResearchMetastatic castration-resistant prostate cancerObjective response rateCastration-resistant prostate cancerPSA declinePercentage of patientsPooled odds ratioMultivariable analysisAsian menAA menOdds ratioProstate cancerResponse ratePhase III clinical trialsPhase III trialsResistant prostate cancerSite of metastasisIndividual patient dataLogistic regression modelsMeasurable diseaseIII trialsPerformance statusTreatment armsPrognostic importanceC menRisk factorsTROPHY-U-01: A phase II open-label study of sacituzumab govitecan (IMMU-132) in patients with advanced urothelial cancer after progression on platinum-based chemotherapy and/or anti-PD-1/PD-L1 checkpoint inhibitor therapy.
Tagawa S, Petrylak D, Grivas P, Agarwal N, Sternberg C, Hernandez C, Siemon-Hryczyk P, Goswami T, Loriot Y. TROPHY-U-01: A phase II open-label study of sacituzumab govitecan (IMMU-132) in patients with advanced urothelial cancer after progression on platinum-based chemotherapy and/or anti-PD-1/PD-L1 checkpoint inhibitor therapy. Journal Of Clinical Oncology 2019, 37: tps3153-tps3153. DOI: 10.1200/jco.2019.37.15_suppl.tps3153.Peer-Reviewed Original ResearchObjective response rateAdvanced urothelial cancerProgression-free survivalCheckpoint inhibitor therapyPhase 2 trialSacituzumab govitecanUrothelial cancerEvaluable ptsAdverse eventsInhibitor therapyEastern Cooperative Oncology Group performance status scorePhase II open-label studyTrop-2Median progression-free survivalNeutropenia/neutrophil countEpithelial cell surface antigenOpen-label studyPerformance status scorePhase 1/2 trialPlatinum-based chemotherapyActive metabolite SN38Cell surface antigensFebrile neutropeniaMeasurable diseasePivotal cohort
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
2015
Association of changes in measurable disease by RECIST with survival in metastatic castration-resistant prostate cancer (mCRPC).
Sonpavde G, Pond G, Templeton A, Petrylak D, Tombal B, Rosenthal M, Tannock I. Association of changes in measurable disease by RECIST with survival in metastatic castration-resistant prostate cancer (mCRPC). Journal Of Clinical Oncology 2015, 33: 186-186. DOI: 10.1200/jco.2015.33.7_suppl.186.Peer-Reviewed Original ResearchMetastatic castration-resistant prostate cancerProgressive diseaseOverall survivalPartial responseAssociation of changesMeasurable diseaseStable diseaseHazard ratioLandmark analysisDay 90Castration-resistant prostate cancerWorld Health Organization criteriaMeasurable disease responseUnconfirmed partial responseECOG performance statusMedian overall survivalNeutrophil-lymphocyte ratioPhase II trialResponse Evaluation CriteriaProportional hazards regressionAccrual of patientsType of progressionMeasurable lesionsRECIST 1.0VENICE trialPhase 1/2 trial of cabazitaxel with abiraterone acetate in patients with metastatic castration-resistant prostate cancer (mCRPC) progressing after docetaxel and abiraterone acetate: Phase 2 results.
Mateo J, Fizazi K, Pezaro C, Loriot Y, Mehra N, Albiges L, Bianchini D, Varga A, Ryan C, Petrylak D, Shen L, Zhang J, Attard G, De Bono J, Massard C. Phase 1/2 trial of cabazitaxel with abiraterone acetate in patients with metastatic castration-resistant prostate cancer (mCRPC) progressing after docetaxel and abiraterone acetate: Phase 2 results. Journal Of Clinical Oncology 2015, 33: 268-268. DOI: 10.1200/jco.2015.33.7_suppl.268.Peer-Reviewed Original ResearchMetastatic castration-resistant prostate cancerPhase 2 partProgression-free survivalAbiraterone acetateAdverse eventsPrimary endpointTreatment-emergent adverse eventsCastration-resistant prostate cancerECOG PS 0Median PSA-PFSPSA response rateAntitumor activityOpen-label trialDuration of responseCombination of abirateroneMeasurable diseasePSA-PFSRECIST 1.1Secondary endpointsDose intensityOverall survivalPartial responsePS 0PSA responseMedian time
2013
Phase Ib extension study of eribulin mesylate in combination with carboplatin in patients with chemotherapy-naive advanced non-small cell lung cancer (NSCLC).
Raftopoulos H, Aisner J, Kumar K, Goel S, Dittrich C, Jain M, Gopalakrishna P, Salazar P, Jones B, Petrylak D. Phase Ib extension study of eribulin mesylate in combination with carboplatin in patients with chemotherapy-naive advanced non-small cell lung cancer (NSCLC). Journal Of Clinical Oncology 2013, 31: e19145-e19145. DOI: 10.1200/jco.2013.31.15_suppl.e19145.Peer-Reviewed Original ResearchAdvanced non-small cell lung cancerNon-small cell lung cancerDisease control rateProgression-free survivalDuration of responseChemo-naïve patientsAdverse eventsOverall survivalEribulin mesylateDay 1Platinum-based doublet chemotherapyOverall objective response rateCarboplatin AUC 6Combination of eribulinCommon adverse eventsObjective response rateUnexpected safety findingsDose-escalation studyCell lung cancerLung cancer cell linesAUC 6Doublet chemotherapyFebrile neutropeniaMeasurable diseaseCancer cell linesA prognostic model for predicting overall survival in metastatic castrate-resistant prostate cancer (mCRPC) men treated with second-line chemotherapy.
Halabi S, Lin C, Small E, Armstrong A, Kaplan E, Petrylak D, Sternberg C, Shen L, Oudard S, De Bono J, Sartor A. A prognostic model for predicting overall survival in metastatic castrate-resistant prostate cancer (mCRPC) men treated with second-line chemotherapy. Journal Of Clinical Oncology 2013, 31: 5011-5011. DOI: 10.1200/jco.2013.31.15_suppl.5011.Peer-Reviewed Original ResearchMedian overall survivalSecond-line chemotherapyFirst-line chemotherapyOverall survivalPrognostic modelRisk groupsECOG performance statusPhase III trialsBaseline prognostic factorsLow-risk groupProstate cancer menProstate-specific antigenDocetaxel useLine chemotherapyMCRPC settingMeasurable diseaseIII trialsPerformance statusProgressive diseaseVisceral diseasePrognostic factorsHormonal useClinical trialsProspective validationPrognostic variablesA model for predicting overall survival in men with metastatic castrate-resistant prostate cancer (CRPC) for whom first-line chemotherapy failed.
Halabi S, Lin C, Small E, Armstrong A, Kaplan E, Petrylak D, Sternberg C, Shen L, Oudard S, De Bono J, Sartor A. A model for predicting overall survival in men with metastatic castrate-resistant prostate cancer (CRPC) for whom first-line chemotherapy failed. Journal Of Clinical Oncology 2013, 31: 24-24. DOI: 10.1200/jco.2013.31.6_suppl.24.Peer-Reviewed Original ResearchFirst-line chemotherapyCastrate-resistant prostate cancerMedian overall survivalOverall survivalLow-risk groupRisk groupsPrognostic modelHazard ratioMetastatic castrate-resistant prostate cancerECOG performance statusPhase III trialsImportant prognostic factorProstate-specific antigenTime-dependent areaTime-dependent AUCDocetaxel useMCRPC settingMeasurable diseaseIII trialsPerformance statusProgressive diseaseVisceral diseasePrognostic factorsHormonal useClinical trials
2012
Phase I results from a phase I/II study of orteronel, an oral, investigational, nonsteroidal 17,20-lyase inhibitor, with docetaxel and prednisone (DP) in metastatic castration-resistant prostate cancer (mCRPC).
Petrylak D, Gandhi J, Clark W, Heath E, Lin J, Oh W, Agus D, Kucuk O, Moran S, Wang J, Bargfrede M, Liu G. Phase I results from a phase I/II study of orteronel, an oral, investigational, nonsteroidal 17,20-lyase inhibitor, with docetaxel and prednisone (DP) in metastatic castration-resistant prostate cancer (mCRPC). Journal Of Clinical Oncology 2012, 30: 4656-4656. DOI: 10.1200/jco.2012.30.15_suppl.4656.Peer-Reviewed Original ResearchMetastatic castration-resistant prostate cancerSerious AEsFebrile neutropeniaCohort 1Phase I/II studyCastration-resistant prostate cancerCommon serious AEsECOG PS 0/1Median age 68Median PSA declinePhase 1/2 studyPhase II portionLyase inhibitorCastrate menPS 0/1Measurable diseaseMedian PSAPrior chemotherapyPSA declineII studyInfusion reactionsNeutrophil countStandard chemotherapyDose escalationWBC count
2009
A phase I open-label study using lenalidomide and docetaxel in castration- resistant prostate cancer
Petrylak D, Resto-Garces K, Tibyan M, Mohile S. A phase I open-label study using lenalidomide and docetaxel in castration- resistant prostate cancer. Journal Of Clinical Oncology 2009, 27: 5156-5156. DOI: 10.1200/jco.2009.27.15_suppl.5156.Peer-Reviewed Original ResearchMeasurable diseaseDay 1Dose levelsPhase I open-label studyCastration-resistant prostate cancerGrade 3 neutropeniaGrade 3/4 toxicitiesGrade 4 neutropeniaMedian baseline PSAOpen-label studyPost-treatment PSAPrior chemotherapy regimensMetastatic pulmonary nodulesDeep venous thrombosisFurther dose escalationPhase I trialEfficacy of docetaxelNear complete resolutionCycle 1Derivative of thalidomideAntiandrogen withdrawalNCI trialProphylactic anticoagulationTreatment PSAChemotherapy regimens
2006
A phase I open-label, dose escalation study to determine the maximum tolerated dose and to evaluate the safety profile of lenalidomide with every three week docetaxel in subjects with androgen independent prostate cancer
Moss R, Shelton G, Melia J, Mohile S, Petrylak D. A phase I open-label, dose escalation study to determine the maximum tolerated dose and to evaluate the safety profile of lenalidomide with every three week docetaxel in subjects with androgen independent prostate cancer. Journal Of Clinical Oncology 2006, 24: 14618-14618. DOI: 10.1200/jco.2006.24.18_suppl.14618.Peer-Reviewed Original ResearchAndrogen-independent prostate cancerIndependent prostate cancerMeasurable diseaseProstate cancerSerum prostate-specific antigen levelProstate-specific antigen levelDose escalation schedulePrior chemotherapy regimensEvidence of progressionFurther dose escalationPhase I trialSpecific antigen levelsEfficacy of docetaxelDerivative of thalidomideAntiandrogen withdrawalL1 patientsPalliative RTPo bidStable diseaseChemotherapy regimensMedian PSARECIST criteriaEscalation studySerum PSABone metastases