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
2020
351 Pembrolizumab plus lenvatinib vs chemotherapy and lenvatinib monotherapy for recurrent/metastatic head and neck squamous cell carcinoma that progressed on platinum therapy and immunotherapy: LEAP-009
Harrington K, Cohen E, Siu L, Rischin D, Licitra L, Vermorken J, Le Q, Tahara M, Machiels J, Hawk N, Ge J, Bidadi B, Swaby R, Burtness B. 351 Pembrolizumab plus lenvatinib vs chemotherapy and lenvatinib monotherapy for recurrent/metastatic head and neck squamous cell carcinoma that progressed on platinum therapy and immunotherapy: LEAP-009. Journal For ImmunoTherapy Of Cancer 2020, 8: a376-a376. DOI: 10.1136/jitc-2020-sitc2020.0351.Peer-Reviewed Original ResearchPlatinum-based chemotherapyRecurrent/metastatic headNeck squamous cell carcinomaECOG performance statusSquamous cell carcinomaDisease progressionLenvatinib monotherapyM HNSCCCell carcinomaRECIST v1.1SOC chemotherapyMetastatic headMonotherapy armPerformance statusTreatment optionsPhase Ib/II trialStandard first-line treatment optionPD-L1 tumor proportion scoreFirst-line treatment optionAdvanced renal cell carcinomaJ Clin OncolSafety of pembrolizumabPD-1 inhibitorsPlatinum-containing chemotherapyAdvanced solid tumors
2018
Efficacy and safety of pembrolizumab in recurrent/metastatic head and neck squamous cell carcinoma: pooled analyses after long-term follow-up in KEYNOTE-012
Mehra R, Seiwert TY, Gupta S, Weiss J, Gluck I, Eder JP, Burtness B, Tahara M, Keam B, Kang H, Muro K, Geva R, Chung HC, Lin CC, Aurora-Garg D, Ray A, Pathiraja K, Cheng J, Chow LQM, Haddad R. Efficacy and safety of pembrolizumab in recurrent/metastatic head and neck squamous cell carcinoma: pooled analyses after long-term follow-up in KEYNOTE-012. British Journal Of Cancer 2018, 119: 153-159. PMID: 29955135, PMCID: PMC6048158, DOI: 10.1038/s41416-018-0131-9.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAntibodies, Monoclonal, HumanizedB7-H1 AntigenDrug-Related Side Effects and Adverse ReactionsFemaleFollow-Up StudiesGene Expression Regulation, NeoplasticHumansKaplan-Meier EstimateMaleMiddle AgedNeoplasm MetastasisNeoplasm Recurrence, LocalProgression-Free SurvivalSquamous Cell Carcinoma of Head and NeckConceptsTreatment-related adverse eventsNeck squamous cell carcinomaSquamous cell carcinomaAdverse eventsCell carcinomaDurable anti-tumor activityRecurrent/metastatic headRecurrent/metastatic HNSCCEfficacy of pembrolizumabSafety of pembrolizumabTolerable safety profileUse of pembrolizumabMedian response durationNon-randomised trialsOverall response rateCo-primary endpointsTreatment of HNSCCYears of treatmentAnti-tumor activityConclusionsSome patientsKEYNOTE-012MethodsMulti-centreGrade 3/4Metastatic headAdvanced head
2016
Efficacy and safety of pembrolizumab in recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC): Pooled analyses after long-term follow-up in KEYNOTE-012.
Mehra R, Seiwert T, Mahipal A, Weiss J, Berger R, Eder J, Burtness B, Tahara M, Keam B, Le D, Muro K, Geva R, Chung H, Lin C, Meister A, Hille D, Cheng J, Chow L, Haddad R. Efficacy and safety of pembrolizumab in recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC): Pooled analyses after long-term follow-up in KEYNOTE-012. Journal Of Clinical Oncology 2016, 34: 6012-6012. DOI: 10.1200/jco.2016.34.15_suppl.6012.Peer-Reviewed Original Research
2015
Antitumor activity and safety of pembrolizumab in patients (pts) with advanced squamous cell carcinoma of the head and neck (SCCHN): Preliminary results from KEYNOTE-012 expansion cohort.
Seiwert T, Haddad R, Gupta S, Mehra R, Tahara M, Berger R, Lee S, Burtness B, Le D, Heath K, Blum A, Dolled-Filhart M, Emancipator K, Pathiraja K, Cheng J, Chow L. Antitumor activity and safety of pembrolizumab in patients (pts) with advanced squamous cell carcinoma of the head and neck (SCCHN): Preliminary results from KEYNOTE-012 expansion cohort. Journal Of Clinical Oncology 2015, 33: lba6008-lba6008. DOI: 10.1200/jco.2015.33.18_suppl.lba6008.Peer-Reviewed Original ResearchRecurrent/metastatic SCCHNOverall response rateDrug-related adverse eventsProgression-free survivalAdverse eventsMetastatic SCCHNPD-L1KEYNOTE-012Expansion cohortOverall survivalCommon drug-related adverse eventsTumor-specific effector T cellsResponse rateAdvanced squamous cell carcinomaDrug-related gradePost-baseline scanSafety of pembrolizumabPrimary end pointLines of therapyPD-L1 expressionEffector T cellsSquamous cell carcinomaHumanized monoclonal antibodyPreliminary efficacy analysisAdvanced SCCHNAntitumor activity and safety of pembrolizumab in patients (pts) with advanced squamous cell carcinoma of the head and neck (SCCHN): Preliminary results from KEYNOTE-012 expansion cohort.
Seiwert T, Haddad R, Gupta S, Mehra R, Tahara M, Berger R, Lee S, Burtness B, Le D, Heath K, Blum A, Dolled-Filhart M, Emancipator K, Pathiraja K, Cheng J, Chow L. Antitumor activity and safety of pembrolizumab in patients (pts) with advanced squamous cell carcinoma of the head and neck (SCCHN): Preliminary results from KEYNOTE-012 expansion cohort. Journal Of Clinical Oncology 2015, 33: lba6008-lba6008. DOI: 10.1200/jco.2015.33.15_suppl.lba6008.Peer-Reviewed Original Research