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 cutoff
2019
919P Three-year follow-up from the phase III KEYNOTE-045 trial: Pembrolizumab (Pembro) versus investigator’s choice (paclitaxel, docetaxel, or vinflunine) in recurrent, advanced urothelial cancer (UC)
Necchi A, Fradet Y, Bellmunt J, de Wit R, Lee J, Fong L, Vozelgang N, Climent M, Petrylak D, Choueiri T, Gerritsen W, Gurney H, Quinn D, Culine S, Sternberg C, Nam K, Frenkl T, Godwin J, Bajorin D, Vaughn D. 919P Three-year follow-up from the phase III KEYNOTE-045 trial: Pembrolizumab (Pembro) versus investigator’s choice (paclitaxel, docetaxel, or vinflunine) in recurrent, advanced urothelial cancer (UC). Annals Of Oncology 2019, 30: v366-v367. DOI: 10.1093/annonc/mdz249.018.Peer-Reviewed Original ResearchGenentech/RocheDuration of responseCaris Life SciencesBristol-Myers SquibbMetastatic urothelial cancerSubsidiary of MerckUrothelial cancerDohme Corp.US OncologyMerck SharpAdverse eventsRoche LaboratoriesJanssen-CilagInvestigator's choiceKey secondary end pointMedian DORTreatment-related adverse eventsSeattle GeneticsAdvanced urothelial cancerECOG PS 0Kidney Cancer AssociationPlatinum-containing regimenSecondary end pointsAstellas PharmaCancer Study Group
2018
Pembrolizumab (pembro) versus investigator’s choice (paclitaxel, docetaxel, or vinflunine) in recurrent, advanced urothelial cancer (UC): 2-year follow-up from the phase 3 KEYNOTE-045 trial.
Fradet Y, Bellmunt J, De Wit R, Vaughn D, Lee J, Fong L, Vogelzang N, Climent M, Petrylak D, Choueiri T, Necchi A, Gerritsen W, Gurney H, Quinn D, Culine S, Sternberg C, Nam K, Frenkl T, Perini R, Bajorin D. Pembrolizumab (pembro) versus investigator’s choice (paclitaxel, docetaxel, or vinflunine) in recurrent, advanced urothelial cancer (UC): 2-year follow-up from the phase 3 KEYNOTE-045 trial. Journal Of Clinical Oncology 2018, 36: 4521-4521. DOI: 10.1200/jco.2018.36.15_suppl.4521.Peer-Reviewed Original ResearchMetastatic urothelial cancerUrothelial cancerInvestigator's choiceAdverse eventsPrimary efficacy end pointTreatment-related adverse eventsEnd pointAdvanced urothelial cancerPlatinum-containing regimenEfficacy end pointSecondary end pointsKaplan-Meier methodPlatinum-based chemotherapyRisk factor groupsBaseline hemoglobinECOG PSMedian OSOS benefitPrior therapyEligible patientsLiver metastasesMedian durationPembroInterim analysisExpression subgroupsTwo-year follow-up from the phase 3 KEYNOTE-045 trial of pembrolizumab (pembro) vs investigator’s choice (paclitaxel, docetaxel, or vinflunine) in recurrent, advanced urothelial cancer (UC).
Bellmunt J, 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, Nam K, Frenkl T, Perini R, Bajorin D. Two-year follow-up from the phase 3 KEYNOTE-045 trial of pembrolizumab (pembro) vs investigator’s choice (paclitaxel, docetaxel, or vinflunine) in recurrent, advanced urothelial cancer (UC). Journal Of Clinical Oncology 2018, 36: 410-410. DOI: 10.1200/jco.2018.36.6_suppl.410.Peer-Reviewed Original ResearchMetastatic urothelial cancerUrothelial cancerInvestigator's choiceAdverse eventsPrimary efficacy end pointTreatment-related adverse eventsEnd pointAdvanced urothelial cancerPlatinum-containing regimenEfficacy end pointSecondary end pointsKaplan-Meier methodPlatinum-based chemotherapyRisk factor groupsECOG PSBaseline hemoglobinEligible patientsMedian OSOS benefitPrior therapyMedian durationLiver metastasesPembroInterim analysisExpression subgroups
2017
Health-related quality of life (HRQoL) of pembrolizumab (pembro) vs chemotherapy (chemo) for previously treated advanced urothelial cancer (UC) in KEYNOTE-045.
De Wit R, Bajorin D, Bellmunt J, 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, Li H, Perini R, Vaughn D. Health-related quality of life (HRQoL) of pembrolizumab (pembro) vs chemotherapy (chemo) for previously treated advanced urothelial cancer (UC) in KEYNOTE-045. Journal Of Clinical Oncology 2017, 35: 4530-4530. DOI: 10.1200/jco.2017.35.15_suppl.4530.Peer-Reviewed Original ResearchAdvanced urothelial cancerGlobal health status/QoL scoreUrothelial cancerKEYNOTE-045HRQoL instrumentsQOL scoresWk 15Cox proportional hazards modelStratified log-rank testHRQOL end pointsSecond-line therapyTreatment-related AEsHealth-related qualityLog-rank testProportional hazards modelSuperior OSBetter HRQoLHRQoL analysisStudy treatmentPembroHazards modelInvestigator's choiceRate of improvementLongitudinal data analysis modelEnd pointHealth-related quality of life (HRQoL) in the KEYNOTE-045 study of pembrolizumab versus investigator-choice chemotherapy for previously treated advanced urothelial cancer.
Vaughn D, Bellmunt J, De Wit R, 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, Li H, Perini R, Bajorin D. Health-related quality of life (HRQoL) in the KEYNOTE-045 study of pembrolizumab versus investigator-choice chemotherapy for previously treated advanced urothelial cancer. Journal Of Clinical Oncology 2017, 35: 282-282. DOI: 10.1200/jco.2017.35.6_suppl.282.Peer-Reviewed Original ResearchGlobal health status/QoL scoreAdvanced UCKEYNOTE-045HRQoL instrumentsQOL scoresWk 15Cox proportional hazards modelStratified log-rank testAdvanced urothelial cancerHRQOL end pointsInvestigator-choice chemotherapySecond-line therapyTreatment-related AEsHealth-related qualityLog-rank testProportional hazards modelSuperior OSBetter HRQoLHRQoL analysisUrothelial cancerStudy treatmentPembroHazards modelInvestigator's choiceRate of improvement