2024
Safety profile of pembrolizumab monotherapy based on an aggregate safety evaluation of 8937 patients
Brahmer J, Long G, Hamid O, Garon E, Herbst R, Andre T, Armand P, Bajorin D, Bellmunt J, Burtness B, Choueiri T, Cohen E, Diaz L, Shitara K, Kulkarni G, McDermott D, Shah M, Tabernero J, Vogel A, Zinzani P, Jafari N, Bird S, Snyder E, Gause C, Bracco O, Pietanza M, Gruber T, Ribas A. Safety profile of pembrolizumab monotherapy based on an aggregate safety evaluation of 8937 patients. European Journal Of Cancer 2024, 199: 113530. PMID: 38295556, PMCID: PMC11227881, DOI: 10.1016/j.ejca.2024.113530.Peer-Reviewed Original ResearchConceptsImmune-mediated adverse eventsAdverse eventsInfusion reactionsSafety profileClinical trialsPembrolizumab discontinuationPembrolizumab monotherapyNon-small cell lung cancerSafety of pembrolizumabDose of pembrolizumabTreated with prednisoneCell lung cancerLow steroid dosesPopulation of patientsSteroid doseMedian durationPembrolizumabAE onsetPooled analysisLung cancerCancer clinical trialsSafety dataPatientsCancer typesInfusion
2016
Pembrolizumab for patients with PD-L1-positive advanced gastric cancer (KEYNOTE-012): a multicentre, open-label, phase 1b trial
Muro K, Chung HC, Shankaran V, Geva R, Catenacci D, Gupta S, Eder JP, Golan T, Le DT, Burtness B, McRee AJ, Lin CC, Pathiraja K, Lunceford J, Emancipator K, Juco J, Koshiji M, Bang YJ. Pembrolizumab for patients with PD-L1-positive advanced gastric cancer (KEYNOTE-012): a multicentre, open-label, phase 1b trial. The Lancet Oncology 2016, 17: 717-726. PMID: 27157491, DOI: 10.1016/s1470-2045(16)00175-3.Peer-Reviewed Original ResearchConceptsTreatment-related adverse eventsPost-baseline scanPhase 1b trialGastro-oesophageal junctionPD-L1Gastric cancerAdverse eventsMetastatic adenocarcinomaGrade 3 peripheral sensory neuropathyPositive advanced gastric cancerSolid Tumors version 1.1Anti-PD-1 antibodyDose of pembrolizumabGrade 3 fatigueGrade 4 pneumonitisMetastatic PD-L1Treatment-related deathsUnacceptable toxic effectsManageable toxicity profilePeripheral sensory neuropathyProportion of patientsResponse Evaluation CriteriaAdvanced gastric cancerPopulation of patientsClinical disease progression