2024
1622P A phase II study of the first-in-class oral innate immune activator BXCL701 with pembrolizumab in patients with metastatic castration-resistant prostate cancer (mCRPC): Long-term follow-up
Aggarwal R, Tagawa S, Monk P, Zhu X, Jones R, Linch M, Costin D, de Bono J, Karsh L, Petrylak D, Borderies P, Deshpande R, O'Neill V, Zhang J. 1622P A phase II study of the first-in-class oral innate immune activator BXCL701 with pembrolizumab in patients with metastatic castration-resistant prostate cancer (mCRPC): Long-term follow-up. Annals Of Oncology 2024, 35: s979. DOI: 10.1016/j.annonc.2024.08.1703.Peer-Reviewed Original ResearchSacituzumab Govitecan Demonstrates Efficacy across Tumor Trop-2 Expression Levels in Patients with Advanced Urothelial Cancer.
Loriot Y, Balar A, Petrylak D, Kalebasty A, Grivas P, Fléchon A, Jain R, Swami U, Bupathi M, Barthélémy P, Beuzeboc P, Palmbos P, Kyriakopoulos C, Pouessel D, Sternberg C, Tonelli J, Sierecki M, Zavodovskaya M, Elboudwarej E, Diehl L, Jürgensmeier J, Tagawa S. Sacituzumab Govitecan Demonstrates Efficacy across Tumor Trop-2 Expression Levels in Patients with Advanced Urothelial Cancer. Clinical Cancer Research 2024, 30: 3179-3188. PMID: 39086310, DOI: 10.1158/1078-0432.ccr-23-3924.Peer-Reviewed Original ResearchConceptsTrop-2 expressionTrop-2Positive tumor cellsUrothelial cancerMetastatic UCSacituzumab govitecanTumor cellsTumor samplesOpen-label phase II studyTrophoblast cell surface antigen 2Human trophoblast cell-surface antigen 2Advanced urothelial cancerSN-38 payloadPhase II studyC1-3Archival tumor samplesExpression levelsCohorts 1 to 3Surface antigen 2Antibody drug conjugatesOS benefitII studyExamined tumorsH-scoreMembrane expressionSacituzumab Govitecan in Combination With Pembrolizumab for Patients With Metastatic Urothelial Cancer That Progressed After Platinum-Based Chemotherapy: TROPHY-U-01 Cohort 3
Grivas P, Pouessel D, Park C, Barthelemy P, Bupathi M, Petrylak D, Agarwal N, Gupta S, Fléchon A, Ramamurthy C, Davis N, Recio-Boiles A, Sternberg C, Bhatia A, Pichardo C, Sierecki M, Tonelli J, Zhou H, Tagawa S, Loriot Y. Sacituzumab Govitecan in Combination With Pembrolizumab for Patients With Metastatic Urothelial Cancer That Progressed After Platinum-Based Chemotherapy: TROPHY-U-01 Cohort 3. Journal Of Clinical Oncology 2024, 42: 1415-1425. PMID: 38261969, PMCID: PMC11095901, DOI: 10.1200/jco.22.02835.Peer-Reviewed Original ResearchMetastatic urothelial cancerPlatinum-based chemotherapyClinical benefit rateProgression-free survivalDuration of responseSacituzumab govitecanCheckpoint inhibitorsCohort 3Central reviewUrothelial cancerFirst-line platinum-based chemotherapyOpen-label phase II studyDay 1Median duration of responseMedian progression-free survivalTreatment-related adverse eventsMedian overall survivalMedian follow-upPhase II studySecondary end pointsAntibody-drug conjugatesMetastatic settingOverall survivalStandard therapyII study
2023
1803P Phase I/II study of bavdegalutamide, a PROTAC androgen receptor (AR) degrader in metastatic castration-resistant prostate cancer (mCRPC): Radiographic progression-free survival (rPFS) in patients (pts) with AR ligand-binding domain (LBD) mutations
Petrylak D, Garmezy B, Shen J, Kalebasty A, Sartor O, Dreicer R, Agarwal N, Hussain M, Percent I, Heath E, Gedrich R, Yu T, Healey D, Parameswaran J, Sternberg C, Gao X. 1803P Phase I/II study of bavdegalutamide, a PROTAC androgen receptor (AR) degrader in metastatic castration-resistant prostate cancer (mCRPC): Radiographic progression-free survival (rPFS) in patients (pts) with AR ligand-binding domain (LBD) mutations. Annals Of Oncology 2023, 34: s973-s974. DOI: 10.1016/j.annonc.2023.09.2751.Peer-Reviewed Original ResearchEnfortumab Vedotin With or Without Pembrolizumab in Cisplatin-Ineligible Patients With Previously Untreated Locally Advanced or Metastatic Urothelial Cancer
O'Donnell P, Milowsky M, Petrylak D, Hoimes C, Flaig T, Mar N, Moon H, Friedlander T, McKay R, Bilen M, Srinivas S, Burgess E, Ramamurthy C, George S, Geynisman D, Bracarda S, Borchiellini D, Geoffrois L, Rey J, Ferrario C, Carret A, Yu Y, Guseva M, Moreno B, Rosenberg J. Enfortumab Vedotin With or Without Pembrolizumab in Cisplatin-Ineligible Patients With Previously Untreated Locally Advanced or Metastatic Urothelial Cancer. Journal Of Clinical Oncology 2023, 41: 4107-4117. PMID: 37369081, PMCID: PMC10852367, DOI: 10.1200/jco.22.02887.Peer-Reviewed Original ResearchConceptsTreatment-related adverse eventsCisplatin-ineligible patientsDuration of responseMetastatic urothelial cancerUrothelial cancerAdverse eventsHigher treatment-related adverse eventsPhase Ib/II studyMedian DORFirst-line treatment optionEnd pointBlinded independent central reviewCommon grade 3Objective response ratePrimary end pointSecondary end pointsNew safety signalsCisplatin-based therapyIndependent central reviewUntreated LACombination armDurable responsesII studyMaculopapular rashSurvival benefit
2021
Sapanisertib, 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
2020
BT8009-100 phase I/II study of the safety, pharmacokinetics, & preliminary clinical activity of BT8009 in patients with Nectin-4 expressing advanced malignancies
Mckean M, Bendell J, Petrylak D, Powles T, Sonpavde G, Dickson A, Dosunmu L, Hennessy M, Jeffrey P, Rigby M, West T. BT8009-100 phase I/II study of the safety, pharmacokinetics, & preliminary clinical activity of BT8009 in patients with Nectin-4 expressing advanced malignancies. Annals Of Oncology 2020, 31: s500-s501. DOI: 10.1016/j.annonc.2020.08.713.Peer-Reviewed Original ResearchTROPHY-U-01 cohort 1 final results: A phase II study of sacituzumab govitecan (SG) in metastatic urothelial cancer (mUC) that has progressed after platinum (PLT) and checkpoint inhibitors (CPI)
Loriot Y, Balar A, Petrylak D, Tagawa S, Rezazadeh A, Fléchon A, Jain R, Agarwal N, Bupathi M, Barthélémy P, Beuzeboc P, Palmbos P, Kyriakopoulos C, Pouessel D, Sternberg C, Hong Q, Goswami T, Itri L, Grivas P. TROPHY-U-01 cohort 1 final results: A phase II study of sacituzumab govitecan (SG) in metastatic urothelial cancer (mUC) that has progressed after platinum (PLT) and checkpoint inhibitors (CPI). Annals Of Oncology 2020, 31: s1156. DOI: 10.1016/j.annonc.2020.08.2253.Peer-Reviewed Original Research
2018
793PD Preliminary results from TRITON2: A phase II study of rucaparib in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC) associated with homologous recombination repair (HRR) gene alterations
Abida W, Bryce A, Vogelzang N, Amato R, Percent I, Shapiro J, McDermott R, Hussain A, Patnaik A, Petrylak D, Ryan C, Stanton T, Zhang J, Simmons A, Despain D, Collins M, Golsorskhi T, Scher H, Chowdhury S. 793PD Preliminary results from TRITON2: A phase II study of rucaparib in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC) associated with homologous recombination repair (HRR) gene alterations. Annals Of Oncology 2018, 29: viii272. DOI: 10.1093/annonc/mdy284.002.Peer-Reviewed Original ResearchTRITON2: An international, multicenter, open-label, phase II study of the PARP inhibitor rucaparib in patients with metastatic castration-resistant prostate cancer (mCRPC) associated with homologous recombination deficiency (HRD).
Abida W, Bryce A, Balar A, Chatta G, Dawson N, Guancial E, Hussain A, Jha G, Lipsitz D, Patnaik A, Petrylak D, Ryan C, Stanton T, Vogelzang N, Zhang J, Simmons A, Go J, Golsorkhi T, Chowdhury S, Scher H. TRITON2: An international, multicenter, open-label, phase II study of the PARP inhibitor rucaparib in patients with metastatic castration-resistant prostate cancer (mCRPC) associated with homologous recombination deficiency (HRD). Journal Of Clinical Oncology 2018, 36: tps388-tps388. DOI: 10.1200/jco.2018.36.6_suppl.tps388.Peer-Reviewed Original ResearchMetastatic castration-resistant prostate cancerHomologous recombination deficiencyNodal diseaseDeleterious germlineProstate cancerProstate-specific antigen (PSA) responseRadiographic progression-free survivalCastration-resistant prostate cancerDNA repair genesClinical benefit rateObjective response ratePhase 2 studyPhase II studyProgression-free survivalTaxane-based chemotherapyHomologous recombination (HR) DNA repair genesPlatinum-based chemotherapyPretreatment blood samplesAdvanced prostate cancerDuration of responseSoft tissue diseaseRepair genesPrimary endpointSecondary endpointsII study
2015
21LBA Atezolizumab in patients (pts) with locally-advanced or metastatic urothelial carcinoma (mUC): Results from a pivotal multicenter phase II study (IMvigor 210)
Rosenberg J, Petrylak D, Abidoye O, Van der Heijden M, Hofman-Censits J, Necchi A, O'Donnell P, Balmanoukian A, Loriot Y, Retz M, Perez-Gracia J, Dawson N, Balar A, Galsky M, Fleming M, Powles T, Cui N, Mariathasan S, Fine G, Dreicer R. 21LBA Atezolizumab in patients (pts) with locally-advanced or metastatic urothelial carcinoma (mUC): Results from a pivotal multicenter phase II study (IMvigor 210). European Journal Of Cancer 2015, 51: s720. DOI: 10.1016/s0959-8049(16)31942-6.Peer-Reviewed Original ResearchFirst-line randomized phase II study of gemcitabine/cisplatin plus apatorsen or placebo in patients with advanced bladder cancer: The International Borealis-1 trial.
Bellmunt J, Eigl B, Senkus-Konefka E, Loriot Y, Twardowski P, Castellano D, Blais N, Sridhar S, Sternberg C, Retz M, Blumenstein B, Jacobs C, Stewart P, Petrylak D. First-line randomized phase II study of gemcitabine/cisplatin plus apatorsen or placebo in patients with advanced bladder cancer: The International Borealis-1 trial. Journal Of Clinical Oncology 2015, 33: 4503-4503. DOI: 10.1200/jco.2015.33.15_suppl.4503.Peer-Reviewed Original Research
2013
A phase I/II study of safety and efficacy of orteronel (TAK-700), an oral, investigational, nonsteroidal 17,20-lyase inhibitor, with docetaxel and prednisone (DP) in metastatic castration-resistant prostate cancer (mCRPC): Updated phase II results.
Petrylak D, Gandhi J, Clark W, Heath E, Lin J, Oh W, Agus D, Carthon B, Moran S, Kong N, Suri A, Bargfrede M, Liu G. A phase I/II study of safety and efficacy of orteronel (TAK-700), an oral, investigational, nonsteroidal 17,20-lyase inhibitor, with docetaxel and prednisone (DP) in metastatic castration-resistant prostate cancer (mCRPC): Updated phase II results. Journal Of Clinical Oncology 2013, 31: 59-59. DOI: 10.1200/jco.2013.31.6_suppl.59.Peer-Reviewed Original ResearchMetastatic castration-resistant prostate cancerPSA responseMedian timePhase I/II studyCastration-resistant prostate cancerDrug-related SAEsECOG PS 0/1Good PSA responseProgression of PsAPhase 1/2 studyPartial tumor responsePhase II resultsBlood alkaline phosphataseCastrate menPS 0/1Median PSAPrior chemotherapyPSA declinePSA progressionRadiologic progressionRECIST 1.1Data cutoffII studyRadiographic diseaseSerum PSA
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
2008
Efficacy and safety of docetaxel in the elderly
Mohile S, Berenji F, Sahasrabudhe D, Morrow G, Petrylak D. Efficacy and safety of docetaxel in the elderly. Aging Health 2008, 4: 113-127. DOI: 10.2217/1745509x.4.2.113.Peer-Reviewed Original ResearchElderly patientsWeekly dosingSide effectsSafety of docetaxelPhase II studyCommon side effectsElderly cancer patientsIncidence of myelosuppressionMost side effectsSolid tumor malignanciesEffective chemotherapeutic agentSignificant age-related effectsDermatologic toxicitiesII studyAdverse eventsDosing schedulesHypersensitivity reactionsCancer patientsFluid retentionAge-related effectsDose reductionTreatment planCancer subtypesTumor malignancyChemotherapeutic agents
2007
4534 POSTER Phase II study of single-agent vinflunine in platinum-refractory transitional cell carcinoma of the urothelium (TCCU)
George C, Vaughn D, Petrylak D, Srinivas S, Pili R, Stadler W, De Marco S, Smith D, Nason S, DeWit E. 4534 POSTER Phase II study of single-agent vinflunine in platinum-refractory transitional cell carcinoma of the urothelium (TCCU). European Journal Of Cancer Supplements 2007, 5: 309. DOI: 10.1016/s1359-6349(07)71165-5.Peer-Reviewed Original ResearchPhase 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 carcinoma
2005
A pilot multicenter phase II study of adjuvant docetaxel (D) for high risk prostate cancer (PC) patients (pts) after radical prostatectomy (RP): Preliminary data
Rosenbaum E, Kibel A, Roth B, Wilding G, Dreicer R, Chatta G, Petrylak D, Dipaula R, Beer T, Eisenberger M. A pilot multicenter phase II study of adjuvant docetaxel (D) for high risk prostate cancer (PC) patients (pts) after radical prostatectomy (RP): Preliminary data. Journal Of Clinical Oncology 2005, 23: 4565-4565. DOI: 10.1200/jco.2005.23.16_suppl.4565.Peer-Reviewed Original Research
2004
Phase II study of DHA-paclitaxel (TXP) as first line chemotherapy in patients with hormone refractory prostate cancer (HRPC)
Bellet R, Carducci M, Petrylak D, Kasimis B, Irwin D, Modiano M, Mansour R, Axelrod R, Doukas M. Phase II study of DHA-paclitaxel (TXP) as first line chemotherapy in patients with hormone refractory prostate cancer (HRPC). Journal Of Clinical Oncology 2004, 22: 4657-4657. DOI: 10.1200/jco.2004.22.14_suppl.4657.Peer-Reviewed Original ResearchPhase II study of DHA-paclitaxel (TXP) as first line chemotherapy in patients with hormone refractory prostate cancer (HRPC)
Bellet R, Carducci M, Petrylak D, Kasimis B, Irwin D, Modiano M, Mansour R, Axelrod R, Doukas M. Phase II study of DHA-paclitaxel (TXP) as first line chemotherapy in patients with hormone refractory prostate cancer (HRPC). Journal Of Clinical Oncology 2004, 22: 4657-4657. DOI: 10.1200/jco.2004.22.90140.4657.Peer-Reviewed Original Research