2022
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.
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
CheckMate 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 tumors
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 toxicityMEDI3726, a prostate-specific membrane antigen (PSMA)-targeted antibody-drug conjugate (ADC) in mCRPC after failure of abiraterone or enzalutamide.
De Bono J, Fleming M, Wang J, Cathomas R, Williams M, Bothos J, Balic K, Cho S, Martinez P, Petrylak D. MEDI3726, a prostate-specific membrane antigen (PSMA)-targeted antibody-drug conjugate (ADC) in mCRPC after failure of abiraterone or enzalutamide. Journal Of Clinical Oncology 2020, 38: 99-99. DOI: 10.1200/jco.2020.38.6_suppl.99.Peer-Reviewed Original ResearchDrug-related adverse eventsAdverse eventsAntibody-drug conjugatesMedian progression-free survivalComposite response rateGrade 3 thrombocytopeniaMedian overall survivalProgression-free survivalTaxane-based therapyPhase 1 studyDuration of responseProstate-specific membrane antigenDrug-related deathsTumor cell countPrior regimensRECIST v1.1Grade 3/4PSA decreaseStarting doseOverall survivalUnacceptable toxicityMedian ageDose escalationAntidrug antibodiesEfficacy analysisAnalysis of clinical outcomes according to response status in prospective clinical trials of atezolizumab (atezo) in pretreated locally advanced/metastatic urothelial carcinoma (mUC).
Bedke J, Merseburger A, Loriot Y, Castellano D, Choy E, Duran I, Rosenberg J, Petrylak D, Dreicer R, Perez-Gracia J, Hoffman-Censits J, Van Der Heijden M, Degaonkar V, Thiebach L, de Ducla S, Fear S, Powles T, Sternberg C. Analysis of clinical outcomes according to response status in prospective clinical trials of atezolizumab (atezo) in pretreated locally advanced/metastatic urothelial carcinoma (mUC). Journal Of Clinical Oncology 2020, 38: 492-492. DOI: 10.1200/jco.2020.38.6_suppl.492.Peer-Reviewed Original ResearchMetastatic urothelial carcinomaStable diseasePartial responseDisease controlBaseline characteristicsRisk factorsPR/stable diseaseOverall survival durationProspective clinical trialsBroader patient populationAnalysis of outcomesData cutoffUnacceptable toxicityWorse OSComplete responseClinical outcomesMedian timeAnalysis populationPatient populationUrothelial carcinomaSurvival durationClinical trialsCohort 2Disease progressionResponse statusRelationship between hyperphosphatemia with infigratinib (BGJ398) and efficacy in FGFR3 -altered advanced/metastatic urothelial carcinoma (aUC).
Lyou Y, Grivas P, Rosenberg J, Hoffman-Censits J, Quinn D, Petrylak D, Galsky M, Vaishampayan U, De Giorgi U, Gupta S, Burris H, Rearden J, Ye Y, Wang H, Moran S, Daneshmand S, Bajorin D, Pal S. Relationship between hyperphosphatemia with infigratinib (BGJ398) and efficacy in FGFR3 -altered advanced/metastatic urothelial carcinoma (aUC). Journal Of Clinical Oncology 2020, 38: 576-576. DOI: 10.1200/jco.2020.38.6_suppl.576.Peer-Reviewed Original ResearchDisease control rateOverall response rateTreatment lengthFGFR inhibitorsPrior platinum-based chemotherapyClass effectMedian treatment lengthRECIST 1.0 criteriaCommon adverse eventsMetastatic urothelial carcinomaSignificant clinical activityPlatinum-based chemotherapyPhosphate binder sevelamerMutations/fusionsEligible patientsEfficacy outcomesUnacceptable toxicityAdverse eventsFGFR3 alterationsEfficacy findingsUrothelial carcinomaControl ratePharmacodynamic biomarkersDisease progressionClinical activityPhase III study of pembrolizumab (pembro) plus docetaxel and prednisone for enzalutamide (enza)- or abiraterone acetate (abi)–pretreated patients (pts) with metastatic castration-resistant prostate cancer (mCRPC): KEYNOTE-921.
Petrylak D, Shore N, Bennamoun M, Ratta R, Piulats J, Li B, Schloss C, Fizazi K. Phase III study of pembrolizumab (pembro) plus docetaxel and prednisone for enzalutamide (enza)- or abiraterone acetate (abi)–pretreated patients (pts) with metastatic castration-resistant prostate cancer (mCRPC): KEYNOTE-921. Journal Of Clinical Oncology 2020, 38: tps262-tps262. DOI: 10.1200/jco.2020.38.6_suppl.tps262.Peer-Reviewed Original ResearchMetastatic castration-resistant prostate cancerPrednisone/prednisoloneRECIST v1.1Prostate Cancer Working Group 3Castration-resistant prostate cancerEnd pointAdequate organ functionECOG PS 0Months of screeningPSA response rateSubsequent anticancer therapyAndrogen deprivation therapyPD-1 inhibitorsPrimary end pointSecondary end pointsSingle-agent antitumor activityPhase 3 trialPhase III studyDeprivation therapyPSA progressionUnacceptable toxicityAbiraterone acetateIII studyMetastasis locationPS 0
2019
891TiP KEYNOTE-921: Phase III study of pembrolizumab (pembro) plus docetaxel and prednisone for enzalutamide (enza)- or abiraterone (abi)-pretreated patients (pts) with metastatic castration-resistant prostate cancer (mCRPC)
Petrylak D, Li B, Schloss C, Fizazi K. 891TiP KEYNOTE-921: Phase III study of pembrolizumab (pembro) plus docetaxel and prednisone for enzalutamide (enza)- or abiraterone (abi)-pretreated patients (pts) with metastatic castration-resistant prostate cancer (mCRPC). Annals Of Oncology 2019, 30: v351. DOI: 10.1093/annonc/mdz248.048.Peer-Reviewed Original ResearchMetastatic castration-resistant prostate cancerPrednisone/prednisoloneAndrogen deprivation therapySubsidiary of MerckDohme Corp.Merck SharpKey secondary efficacy end pointsRadiographic progression-free survivalRandomized phase 3 trialSecondary efficacy end pointsCastration-resistant prostate cancerAdequate organ functionECOG PS 0/1Subsequent anticancer therapyEfficacy end pointPhase 3 trialProgression-free survivalRadiographic disease progressionCT/MRIBristol-Myers SquibbAdult ptsDeprivation therapyPS 0/1RECIST v1.1Unacceptable toxicity
2015
Interim results of a randomized phase 2 study of docetaxel with ramucirumab versus docetaxel in second-line advanced or metastatic urothelial carcinoma.
Petrylak D, Tagawa S, Kohli M, Tang S, Zhang H, Hamid O, Kauh J, Walgren R, Chi K. Interim results of a randomized phase 2 study of docetaxel with ramucirumab versus docetaxel in second-line advanced or metastatic urothelial carcinoma. Journal Of Clinical Oncology 2015, 33: 295-295. DOI: 10.1200/jco.2015.33.7_suppl.295.Peer-Reviewed Original ResearchRandomized phase 2 studyMetastatic urothelial carcinomaPhase 2 studyUrothelial carcinomaDisease progressionInterim analysisMetastatic platinum-resistant urothelial carcinomaDisease control rateECOG PS 0ECOG PS 1Investigator-assessed PFSAdvanced urothelial carcinomaCommon adverse eventsFirst-line chemotherapyMedian PFSPlatinum regimenRECIST v1.1Febrile neutropeniaPrimary endpointVisceral metastasesPFS eventsPS 0Unacceptable toxicityAdverse eventsStudy arms