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
Antitumor Activity of Pembrolizumab in Biomarker-Unselected Patients With Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma: Results From the Phase Ib KEYNOTE-012 Expansion Cohort
Chow LQM, Haddad R, Gupta S, Mahipal A, Mehra R, Tahara M, Berger R, Eder JP, Burtness B, Lee SH, Keam B, Kang H, Muro K, Weiss J, Geva R, Lin CC, Chung HC, Meister A, Dolled-Filhart M, Pathiraja K, Cheng JD, Seiwert TY. Antitumor Activity of Pembrolizumab in Biomarker-Unselected Patients With Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma: Results From the Phase Ib KEYNOTE-012 Expansion Cohort. Journal Of Clinical Oncology 2016, 34: 3838-3845. PMID: 27646946, PMCID: PMC6804896, DOI: 10.1200/jco.2016.68.1478.Peer-Reviewed Original ResearchConceptsOverall response rateNeck squamous cell carcinomaProgression-free survivalSquamous cell carcinomaMetastatic headExpansion cohortPD-L1Cell carcinomaAnti-programmed death-1 antibodySix-month progression-free survivalTreatment-related adverse eventsEnd pointDeath-1 antibodyDose of pembrolizumabAntitumor activityPrimary end pointSecondary end pointsHuman papillomavirus (HPV) statusPD-L1 expressionOverall survival rateDurable antitumor activityFrequent dosing scheduleAssociation of responseAdvanced HNSCCM HNSCCSafety and clinical activity of pembrolizumab for treatment of recurrent or metastatic squamous cell carcinoma of the head and neck (KEYNOTE-012): an open-label, multicentre, phase 1b trial
Seiwert TY, Burtness B, Mehra R, Weiss J, Berger R, Eder JP, Heath K, McClanahan T, Lunceford J, Gause C, Cheng JD, Chow LQ. Safety and clinical activity of pembrolizumab for treatment of recurrent or metastatic squamous cell carcinoma of the head and neck (KEYNOTE-012): an open-label, multicentre, phase 1b trial. The Lancet Oncology 2016, 17: 956-965. PMID: 27247226, DOI: 10.1016/s1470-2045(16)30066-3.Peer-Reviewed Original ResearchConceptsMetastatic squamous cell carcinomaSquamous cell carcinomaDrug-related adverse eventsPost-baseline scanPhase 1b trialProportion of patientsCell carcinomaAdverse eventsPD-L1Anti-programmed death receptor 1 antibodyDeath receptor-1 (PD-1) antibodiesPositive squamous cell carcinomaActivity of pembrolizumabDose of pembrolizumabDrug-related rashMeaningful antitumour activityFull analysis setHPV-negative patientsSerious adverse eventsHPV-positive patientsPD-L1 expressionResponse Evaluation CriteriaTreatment of recurrentOverall responseDrug-related deathsPembrolizumab 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