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
Planned survival analysis from KEYNOTE-045: Phase 3, open-label study of pembrolizumab (pembro) versus paclitaxel, docetaxel, or vinflunine in recurrent, advanced urothelial cancer (UC).
Bajorin D, 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, Mai Y, Puhlmann M, Perini R, Bellmunt J. Planned survival analysis from KEYNOTE-045: Phase 3, open-label study of pembrolizumab (pembro) versus paclitaxel, docetaxel, or vinflunine in recurrent, advanced urothelial cancer (UC). Journal Of Clinical Oncology 2017, 35: 4501-4501. DOI: 10.1200/jco.2017.35.15_suppl.4501.Peer-Reviewed Original ResearchAdvanced urothelial cancerUrothelial cancerSurvival analysisPrimary efficacy end pointEnd pointECOG PS 0Efficacy end pointSecond-line chemotherapyTreatment-related AEsOpen-label studySecondary end pointsPD-L1 expressionSuperior safety profileECOG PSKEYNOTE-045Measurable diseaseOS benefitMedian OSPrior therapyBaseline characteristicsLonger OSMedian durationPS 0Systemic therapyLiver metastases