2022
TROPHY-U-01 Cohort 3: Sacituzumab govitecan (SG) in combination with pembrolizumab (Pembro) in patients (pts) with metastatic urothelial cancer (mUC) who progressed after platinum (PLT)-based regimens.
Grivas P, Pouessel D, Park C, Barthélémy P, Bupathi M, Petrylak D, Agarwal N, Flechon A, Ramamurthy C, Davis N, Recio-Boiles A, Tagawa S, Sternberg C, Bhatia A, Pichardo C, Goswami T, Loriot Y. TROPHY-U-01 Cohort 3: Sacituzumab govitecan (SG) in combination with pembrolizumab (Pembro) in patients (pts) with metastatic urothelial cancer (mUC) who progressed after platinum (PLT)-based regimens. Journal Of Clinical Oncology 2022, 40: 434-434. DOI: 10.1200/jco.2022.40.6_suppl.434.Peer-Reviewed Original ResearchObjective response rateTreatment-emergent adverse eventsMetastatic urothelial cancerInvestigator-assessed objective response ratePhase 2 trialProgression-free survivalSacituzumab govitecanCheckpoint inhibitorsEastern Cooperative Oncology Group performance status 0Most common treatment-emergent adverse eventsCommon treatment-emergent adverse eventsSolid Tumors version 1.1Long-term disease controlBlinded independent central reviewAntigen 2 antibodiesClinical benefit rateECOG PS 1Manageable safety profileMedian overall survivalPerformance status 0Phase 2 doseTreatment-related AEsTreatment-related deathsTreatment-related gradeNew safety signalsTROPHY-U-01 cohort 4: Sacituzumab govitecan (SG) in combination with cisplatin (Cis) in platinum (PLT)-naïve patients (pts) with metastatic urothelial cancer (mUC).
Tagawa S, Grivas P, Petrylak D, Sternberg C, Swami U, Bhatia A, Pichardo C, Goswami T, Loriot Y. TROPHY-U-01 cohort 4: Sacituzumab govitecan (SG) in combination with cisplatin (Cis) in platinum (PLT)-naïve patients (pts) with metastatic urothelial cancer (mUC). Journal Of Clinical Oncology 2022, 40: tps581-tps581. DOI: 10.1200/jco.2022.40.6_suppl.tps581.Peer-Reviewed Original ResearchMetastatic urothelial cancerBlinded independent central reviewObjective response rateSacituzumab govitecanOverall survivalDay 1Antibody-drug conjugatesCohort 4Eastern Cooperative Oncology Group performance status 0Prophylactic granulocyte colony-stimulating factorActive interstitial lung diseaseAntigen 2 antibodiesClinical benefit ratePerformance status 0Phase 2 doseStudy drug initiationMedian overall survivalProgression-free survivalPhase 2 trialDose-limiting toxicityInterstitial lung diseaseDuration of responseEfficacy/safetyGranulocyte colony-stimulating factorIndependent central review
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 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
Early results of TROPHY-U-01 Cohort 2: Sacituzumab govitecan (SG) in platinum-ineligible patients (pts) with metastatic urothelial cancer (mUC) who progressed after prior checkpoint inhibitor (CPI) therapy.
Petrylak D, Tagawa S, Jain R, Bupathi M, Balar A, Rezazadeh A, George S, Palmbos P, Nordquist L, Davis N, Vogelzang N, Ramamurthy C, Sternberg C, Loriot Y, Agarwal N, Hong Q, Gladden A, Kanwal C, Goswami T, Grivas P. Early results of TROPHY-U-01 Cohort 2: Sacituzumab govitecan (SG) in platinum-ineligible patients (pts) with metastatic urothelial cancer (mUC) who progressed after prior checkpoint inhibitor (CPI) therapy. Journal Of Clinical Oncology 2020, 38: 5027-5027. DOI: 10.1200/jco.2020.38.15_suppl.5027.Peer-Reviewed Original ResearchMetastatic urothelial cancerOverall response rateTreatment-related AEsSacituzumab govitecanCPI therapySafety profileCohort 2Anti-Trop-2 antibodyFirst-line metastatic settingECOG PS 0Epithelial cell surface antigenPlatinum-ineligible patientsPrior treatment linesTreatment-related deathsCheckpoint inhibitor therapyManageable safety profilePhase 2 trialProgression-free survivalInterstitial lung diseaseDuration of responseMajority of ptsCell surface antigensAdvanced UCCPI treatmentFebrile neutropenia
2019
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.
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 cohortSacituzumab govitecan (IMMU-132) in patients with previously treated metastatic urothelial cancer (mUC): Results from a phase I/II study.
Tagawa S, Faltas B, Lam E, Saylor P, Bardia A, Hajdenberg J, Morgans A, Lim E, Kalinsky K, Simpson P, Galsky M, Goswam T, Wegener W, Petrylak D. Sacituzumab govitecan (IMMU-132) in patients with previously treated metastatic urothelial cancer (mUC): Results from a phase I/II study. Journal Of Clinical Oncology 2019, 37: 354-354. DOI: 10.1200/jco.2019.37.7_suppl.354.Peer-Reviewed Original ResearchMetastatic urothelial cancerObjective response rateProgression-free survivalDuration of responseSacituzumab govitecanOverall survivalPhase I/II studyImmune checkpoint inhibitor therapyMedian DORMedian progression-free survivalNeutropenia/neutrophil countNovel antibody-drug conjugateClinical benefit rateEpithelial cell surface antigenPrior treatment linesCheckpoint inhibitor therapyAdvanced solid tumorsCT/MRI scansPhase 2 trialLimited treatment optionsCell surface antigensAntibody-drug conjugatesAdvanced UCFebrile neutropeniaRECIST 1.1TROPHY-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, Siemon-Hryczyk P, Goswam 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: tps495-tps495. DOI: 10.1200/jco.2019.37.7_suppl.tps495.Peer-Reviewed Original ResearchObjective response rateMetastatic urothelial cancerPlatinum-based chemotherapyCheckpoint inhibitor therapyPhase 2 trialSacituzumab govitecanAdverse eventsInhibitor therapyUrothelial cancerPhase II open-label studyTrop-2Median progression-free survivalAdvanced urothelial cancerEpithelial cell surface antigenMedian overall survivalOpen-label studySafety/tolerabilityProgression-free survivalSingle-arm trialCell surface antigensAdvanced UCEvaluable ptsPrior therapyRECIST 1.1Overall survival
2015
419 Androgen receptor (AR) and AR-V7 expression in circulating tumor cells (CTCs) and response to prostate-specific membrane antigen antibody drug conjugate (PSMA ADC) in castration-resistant prostate cancer: A correlative analysis from a phase 2 trial
Petrylak D, DiPippo V, Werner S, Baird S, Anderson A, Marrinucci D, Israel R. 419 Androgen receptor (AR) and AR-V7 expression in circulating tumor cells (CTCs) and response to prostate-specific membrane antigen antibody drug conjugate (PSMA ADC) in castration-resistant prostate cancer: A correlative analysis from a phase 2 trial. European Journal Of Cancer 2015, 51: s84-s85. DOI: 10.1016/s0959-8049(16)30253-2.Peer-Reviewed Original ResearchA phase 2 study of prostate specific membrane antigen antibody drug conjugate (PSMA ADC) in patients (pts) with progressive metastatic castration-resistant prostate cancer (mCRPC) following abiraterone and/or enzalutamide (abi/enz).
Petrylak D, Vogelzang N, Chatta G, Fleming M, Smith D, Appleman L, Hussain A, Modiano M, Singh P, Tagawa S, Gore I, McClay E, Mega A, Sartor A, Somer B, Wadlow R, Shore N, Stambler N, DiPippo V, Israel R. A phase 2 study of prostate specific membrane antigen antibody drug conjugate (PSMA ADC) in patients (pts) with progressive metastatic castration-resistant prostate cancer (mCRPC) following abiraterone and/or enzalutamide (abi/enz). Journal Of Clinical Oncology 2015, 33: 144-144. DOI: 10.1200/jco.2015.33.7_suppl.144.Peer-Reviewed Original ResearchMetastatic castration-resistant prostate cancerCTC declineProgressive metastatic castration-resistant prostate cancerCastration-resistant prostate cancerAntitumor activityMeasurable target lesionsNeuroendocrine serum markersPhase 2 studyPhase 2 trialPhase 1 studyHigh PSMA expressionProstate cancer cellsPSMA-positive cellsRadiologic responseHuman IgG1 antibodyPSA declineRadiologic evidenceElectrolyte imbalanceSerum markersCTC countEfficacy responseTarget lesionsProstate cancerPSMA expressionEnz treatment
2014
A phase 2 trial of prostate-specific membrane antigen antibody drug conjugate (PSMA ADC) in taxane-refractory metastatic castration-resistant prostate cancer (mCRPC).
Petrylak D, Smith D, Appleman L, Fleming M, Hussain A, Dreicer R, Sartor A, Shore N, Vogelzang N, Youssoufian H, DiPippo V, Stambler N, Huang K, Israel R. A phase 2 trial of prostate-specific membrane antigen antibody drug conjugate (PSMA ADC) in taxane-refractory metastatic castration-resistant prostate cancer (mCRPC). Journal Of Clinical Oncology 2014, 32: 5023-5023. DOI: 10.1200/jco.2014.32.15_suppl.5023.Peer-Reviewed Original ResearchMP70-20 A PHASE 2 TRIAL OF PROSTATE SPECIFIC MEMBRANE ANTIGEN ANTIBODY DRUG CONJUGATE (PSMA ADC) IN TAXANE-TREATED METASTATIC CASTRATION-RESISTANT PROSTATE CANCER (MCRPC)
Petrylak D, Smith D, Appleman L, Fleming M, Hussain A, Dreicer R, Sartor A, Shore N, Vogelzang N, Youssoufian H, Olson W, Stambler N, Huang K, Israel R. MP70-20 A PHASE 2 TRIAL OF PROSTATE SPECIFIC MEMBRANE ANTIGEN ANTIBODY DRUG CONJUGATE (PSMA ADC) IN TAXANE-TREATED METASTATIC CASTRATION-RESISTANT PROSTATE CANCER (MCRPC). Journal Of Urology 2014, 191: e813-e814. DOI: 10.1016/j.juro.2014.02.2218.Peer-Reviewed Original Research870 A phase 2 trial of prostate specific membrane antigen antibody drug conjugate (PSMA ADC) in taxane-treated metastatic castration-resistant prostate cancer (MCRPC)
Petrylak D, Smith D, Appleman L, Fleming M, Hussain A, Dreicer R, Sartor O, Shore N, Vogelzang N, Youssoufian H, Stambler N, Huang K, Israel R. 870 A phase 2 trial of prostate specific membrane antigen antibody drug conjugate (PSMA ADC) in taxane-treated metastatic castration-resistant prostate cancer (MCRPC). European Urology Open Science 2014, 13: e870. DOI: 10.1016/s1569-9056(14)60857-5.Peer-Reviewed Original Research
2013
Prostate-specific membrane antigen antibody drug conjugate (PSMA ADC): A phase I trial in metastatic castration-resistant prostate cancer (mCRPC) previously treated with a taxane.
Petrylak D, Kantoff P, Mega A, Vogelzang N, Stephenson J, Fleming M, Stambler N, Petrini M, Blattman S, Israel R. Prostate-specific membrane antigen antibody drug conjugate (PSMA ADC): A phase I trial in metastatic castration-resistant prostate cancer (mCRPC) previously treated with a taxane. Journal Of Clinical Oncology 2013, 31: 5018-5018. DOI: 10.1200/jco.2013.31.15_suppl.5018.Peer-Reviewed Original ResearchMetastatic castration-resistant prostate cancerProstate-specific membrane antigenProgressive metastatic castration-resistant prostate cancerMonomethyl auristatin ELiver function testsFree MMAEPhase 1 dose-escalation studyCastration-resistant prostate cancerTaxane-containing chemotherapyAntitumor activityDose-escalation studyPhase 2 trialPhase I trialCancer cellsProstate cancer cellsSpecific membrane antigenECOG statusLFT abnormalitiesPrior docetaxelAdverse eventsEscalation studyI trialPeripheral neuropathyAntibody therapyFunction testsProstate-specific membrane antigen antibody drug conjugate (PSMA ADC): A phase I trial in metastatic castration-resistant prostate cancer (mCRPC) previously treated with a taxane.
Petrylak D, Kantoff P, Mega A, Vogelzang N, Stephenson J, Fleming M, Stambler N, Petrini M, Huang K, Israel R. Prostate-specific membrane antigen antibody drug conjugate (PSMA ADC): A phase I trial in metastatic castration-resistant prostate cancer (mCRPC) previously treated with a taxane. Journal Of Clinical Oncology 2013, 31: 119-119. DOI: 10.1200/jco.2013.31.6_suppl.119.Peer-Reviewed Original ResearchMetastatic castration-resistant prostate cancerProstate-specific membrane antigenMonomethyl auristatin EFree MMAEProstate cancer cellsProgressive metastatic castration-resistant prostate cancerDose levelsPhase 1 dose-escalation studyLiver function test elevationsCastration-resistant prostate cancerTaxane-containing chemotherapyAntitumor activityDose-escalation studyPhase 2 trialPhase I trialCancer cellsClinical disease progressionHighest dose levelSpecific membrane antigenECOG statusLFT abnormalitiesPrior docetaxelAdverse eventsEscalation studyI trial
2011
MP-16.01 Cellular and Humoral Immune System Activation by Sipuleucel-T: Preliminary Data from the OpenACT Phase 2 Trial
Petrylak D, Corman J, Hall S, Nabhan C, Ferrari A, Armstrong A, Dawson N, Sims R, Stewart F, Sheikh N. MP-16.01 Cellular and Humoral Immune System Activation by Sipuleucel-T: Preliminary Data from the OpenACT Phase 2 Trial. Urology 2011, 78: s147. DOI: 10.1016/j.urology.2011.07.369.Peer-Reviewed Original Research
2005
Chemotherapy agents and timing of chemotherapy in prostate cancer management
Donohue K, Petrylak D. Chemotherapy agents and timing of chemotherapy in prostate cancer management. Current Prostate Reports 2005, 3: 58-61. DOI: 10.1007/s11918-005-0017-1.Peer-Reviewed Original ResearchHormone-refractory prostate cancerSurvival benefitProstate cancerMetastatic hormone-refractory prostate cancerProstate-specific antigen levelTiming of chemotherapyPhase 2 trialProstate cancer managementMedian survivalPalliative benefitSurvival improvementAntigen levelsClinical trialsChemotherapy agentsCancer managementSingle agentChemotherapeutic agentsDocetaxelTrialsPhase 3Preliminary dataChemotherapyEstramustinePatientsCancer