2023
Updated outcomes in TROPHY-U-01 cohort 1, a phase 2 study of sacituzumab govitecan (SG) in patients (pts) with metastatic urothelial cancer (mUC) that progressed after platinum (PT)-based chemotherapy and a checkpoint inhibitor (CPI).
Tagawa S, Balar A, Petrylak D, Rezazadeh A, Loriot Y, Flechon A, Jain R, Agarwal N, Bupathi M, Barthelemy P, Beuzeboc P, Palmbos P, Kyriakopoulos C, Pouessel D, Sternberg C, Tonelli J, Sierecki M, Zhou H, Grivas P. Updated outcomes in TROPHY-U-01 cohort 1, a phase 2 study of sacituzumab govitecan (SG) in patients (pts) with metastatic urothelial cancer (mUC) that progressed after platinum (PT)-based chemotherapy and a checkpoint inhibitor (CPI). Journal Of Clinical Oncology 2023, 41: 526-526. DOI: 10.1200/jco.2023.41.6_suppl.526.Peer-Reviewed Original ResearchMetastatic urothelial cancerTreatment-related adverse eventsObjective response rateProgression-free survivalDuration of responseClinical benefit ratePhase 2 studyCheckpoint inhibitorsSacituzumab govitecanOverall survivalPrior therapyCentral reviewResponse rateAnti-Trop-2 antibodyAccelerated FDA approvalECOG PS 0Last prior therapyTreatment-related deathsKey secondary endpointNew safety signalsFebrile neutropeniaOS ratesData cutoffPrimary endpointRECIST 1.1
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 1.1
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
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 lines
2012
918P Phase 2 Results from a Phase 1/2 Study of Tak-700 (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, Carthon B, Moran S, Liu G. 918P Phase 2 Results from a Phase 1/2 Study of Tak-700 (ORTERONEL), An Oral, Investigational, Nonsteroidal 17,20-Lyase Inhibitor, with Docetaxel and Prednisone (DP) in Metastatic Castration-Resistant Prostate Cancer (MCRPC). Annals Of Oncology 2012, 23: ix302-ix303. DOI: 10.1016/s0923-7534(20)33476-1.Peer-Reviewed Original ResearchMetastatic castration-resistant prostate cancerPhase 1/2 studyTAK-700Febrile neutropeniaMedian timeCastration-resistant prostate cancerDrug-related SAEsECOG PS 0/1Good PSA responseProgression of PsAPSA response rateTreatment-related AEsPartial tumor responseLyase inhibitorMillennium PharmaceuticalsGlaxo Smith KlineCastrate menEvaluable populationPrior chemotherapyPS 0/1PSA declinePSA progressionRadiologic progressionRECIST 1.1Data cutoffLBA24 A Phase 3 Study to Evaluate the Efficacy and Safety of Docetaxel and Prednisone (DP) with or without Lenalidomide (LEN) in Patients with Castrate-Resistant Prostate Cancer (CRPC): The Mainsail Trial
Petrylak D, Fizazi K, Sternberg C, Budnik N, De Wit R, Wiechno P, Bellmunt J, Barton D, Fandi A, Jungnelius U, Li S, Vogelzang N. LBA24 A Phase 3 Study to Evaluate the Efficacy and Safety of Docetaxel and Prednisone (DP) with or without Lenalidomide (LEN) in Patients with Castrate-Resistant Prostate Cancer (CRPC): The Mainsail Trial. Annals Of Oncology 2012, 23: ixe15. DOI: 10.1016/s0923-7534(20)34329-5.Peer-Reviewed Original ResearchCastrate-resistant prostate cancerProgression-free survivalDP armOverall survivalProgressive metastatic castrate-resistant prostate cancerMetastatic castrate-resistant prostate cancerMethods Chemotherapy-naïve patientsAddition of lenalidomideLower dose intensitySafety of docetaxelSafety of lenalidomideChemotherapy-naïve patientsEarly treatment discontinuationMedian overall survivalObjective response rateECOG PS scoreFirst-line treatmentPhase 1/2 trialShorter treatment durationPhase 3Lack of benefitFebrile neutropeniaMAINSAIL trialNeutropenic sepsisPrimary endpointPhase 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
2007
Phase II study of single-agent vinflunine in platinum-refractory transitional cell carcinoma of the urothelium (TCCU)
Vaughn D, Srinivas S, Stadler W, Pili R, Petrylak D, De Marco S, Smith D, Nason S, De Wit E, George C. Phase II study of single-agent vinflunine in platinum-refractory transitional cell carcinoma of the urothelium (TCCU). Journal Of Clinical Oncology 2007, 25: 15543-15543. DOI: 10.1200/jco.2007.25.18_suppl.15543.Peer-Reviewed Original ResearchInitial doseResponse rateManageable toxicity profileObjective response ratePlatinum-containing regimenPoor performance statusPrior pelvic irradiationPhase II studySingle-arm studyTransitional cell carcinomaVinca alkaloid classNew microtubule inhibitorMales 78Febrile neutropeniaMeasurable lesionsRenal impairmentCreatinine clearanceEfficacy endpointII studyLast doseMain toxicityPelvic irradiationPerformance statusPeripheral neuropathyCell carcinomaPhase II multicenter, two-stage study of E7389 in patients with hormone refractory prostate cancer with advanced and/or metastatic disease stratified by prior chemotherapy
Molife R, Cartwright T, Loesch D, Garbo L, Sonpavde G, Calvo E, Das A, Wanders J, Petrylak D, de Bono J. Phase II multicenter, two-stage study of E7389 in patients with hormone refractory prostate cancer with advanced and/or metastatic disease stratified by prior chemotherapy. Journal Of Clinical Oncology 2007, 25: 15513-15513. DOI: 10.1200/jco.2007.25.18_suppl.15513.Peer-Reviewed Original ResearchHormone-refractory prostate cancerRefractory prostate cancerPSA responsePrior chemotherapyProstate cancerNon-small cell lung cancerSmall cell lung cancerPhase II multicenterRefractory breast cancerSerious adverse eventsSingle-agent activityCell lung cancerProstate cancer cell linesBolus IV infusionTwo-stage studyConcomitant steroidsCancer cell linesChest painFebrile neutropeniaStudy drugAcceptable toxicityMetastatic diseasePrior regimenRenal failureAdverse events