2024
Pembrolizumab Plus Carboplatin and Paclitaxel as First-Line Therapy for Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (KEYNOTE-B10): A Single-Arm Phase IV Trial
Dzienis M, Cundom J, Fuentes C, Spreafico A, Nordlinger M, Pastor A, Alesi E, Neki A, Fung A, Lima I, Oppelt P, da Cunha G, Burtness B, Franke F, Tseng J, Joshi A, McCarthy J, Swaby R, Sidi Y, Gumuscu B, Naicker N, de Castro G. Pembrolizumab Plus Carboplatin and Paclitaxel as First-Line Therapy for Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (KEYNOTE-B10): A Single-Arm Phase IV Trial. Journal Of Clinical Oncology 2024, 42: 2989-2999. PMID: 39038265, PMCID: PMC11361359, DOI: 10.1200/jco.23.02625.Peer-Reviewed Original ResearchBlinded independent central reviewRecurrent/metastatic head and neck squamous cell carcinomaHead and neck squamous cell carcinomaNeck squamous cell carcinomaR/M HNSCCSquamous cell carcinomaRECIST v1.1Cell carcinomaSingle-armStandard-of-care first-line treatmentSafety of first-line pembrolizumabEastern Cooperative Oncology Group performance statusDay 1Treatment-related adverse eventsAlternative chemotherapy combinationsFirst-line pembrolizumabPD-L1 statusMedian follow-upFirst-line therapyIndependent central reviewFirst-line treatmentPhase IV trialChemotherapy combinationsComplete responsePD-L1
2020
Comparing programmed death ligand 1 scores for predicting pembrolizumab efficacy in head and neck cancer
Emancipator K, Huang L, Aurora-Garg D, Bal T, Cohen EEW, Harrington K, Soulières D, Le Tourneau C, Licitra L, Burtness B, Swaby R. Comparing programmed death ligand 1 scores for predicting pembrolizumab efficacy in head and neck cancer. Modern Pathology 2020, 34: 532-541. PMID: 33239737, DOI: 10.1038/s41379-020-00710-9.Peer-Reviewed Original ResearchMeSH KeywordsAntibodies, Monoclonal, HumanizedAntineoplastic Agents, ImmunologicalB7-H1 AntigenBiomarkers, TumorBiopsyClinical Decision-MakingClinical Trials, Phase III as TopicDecision Support TechniquesDisease ProgressionHead and Neck NeoplasmsHumansImmunohistochemistryPredictive Value of TestsProgression-Free SurvivalRandomized Controlled Trials as TopicRetrospective StudiesSquamous Cell Carcinoma of Head and NeckTime FactorsConceptsTumor proportion scoreObjective response ratePD-L1 expression statusDeath ligand 1 (PD-L1) expressionNeck squamous cell carcinomaImmune checkpoint inhibitorsLigand 1 expressionPD-L1 statusProgression-free survivalSquamous cell carcinomaKEYNOTE-040Pembrolizumab efficacyCheckpoint inhibitorsOverall survivalMetastatic HNSCCCell carcinomaNeck cancerClinical trialsProportion scoreInvestigator's choiceResponse rateExpression statusYouden indexHNSCCPatientsPhase III LEAP-010 study: first-line pembrolizumab with or without lenvatinib in recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC).
Siu L, Burtness B, Cohen E, Harrington K, Licitra L, Rischin D, Zhu Y, Lee C, Pinheiro C, Swaby R, Machiels J, Tahara M. Phase III LEAP-010 study: first-line pembrolizumab with or without lenvatinib in recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC). Journal Of Clinical Oncology 2020, 38: tps6589-tps6589. DOI: 10.1200/jco.2020.38.15_suppl.tps6589.Peer-Reviewed Original ResearchBlinded independent central reviewCombined positive scoreFirst-line pembrolizumabM HNSCCDisease progressionRECIST v1.1PD-L1PD-L1 combined positive scoreECOG performance status 0PD-1 inhibitor pembrolizumabRecurrent/metastatic headEnd pointNeck squamous cell carcinomaCycles of pembrolizumabFirst-line monotherapyPerformance status 0Phase 1b/2 trialManageable safety profileObjective response ratePrimary end pointSecondary end pointsHuman papillomavirus (HPV) statusPD-L1 statusPhase 3 studyProgression-free survivalPembrolizumab (P) or P + chemotherapy (C) versus EXTREME (E) as first-line (1L) therapy for recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC): analysis of KEYNOTE-048 by disease state.
Rischin D, Harrington K, Greil R, Soulieres D, Tahara M, Castro G, Psyrri A, Baste N, Neupane P, Bratland Å, Fuereder T, Hughes B, Mesia R, Ngamphaiboon N, Rordorf T, Wan Ishak W, Lin J, Gumuscu B, Swaby R, Burtness B. Pembrolizumab (P) or P + chemotherapy (C) versus EXTREME (E) as first-line (1L) therapy for recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC): analysis of KEYNOTE-048 by disease state. Journal Of Clinical Oncology 2020, 38: 6530-6530. DOI: 10.1200/jco.2020.38.15_suppl.6530.Peer-Reviewed Original ResearchTreatment-related adverse eventsIncurable recurrentMetastatic subgroupM HNSCCSuperior OSMedian OSPFS benefitGrade 3MS subgroupsRecurrent/metastatic headNeck squamous cell carcinomaKEYNOTE-048 trialPD-L1 CPSDisease statesECOG performance statusFirst-line therapyPD-L1 statusKaplan-Meier methodTotal study populationSquamous cell carcinomaCox regression modelKEYNOTE-048Metastatic headAdverse eventsHazard ratio
2019
1115PD Analysis of efficacy outcomes based on programmed death ligand 1 (PD-L1) scoring techniques in patients with head and neck squamous cell carcinoma (HNSCC) from KEYNOTE-040
Cohen E, Harrington K, Soulières D, Le Tourneau C, Licitra L, Burtness B, Bal T, Juco J, Aurora-Garg D, Huang L, Swaby R, Emancipator K. 1115PD Analysis of efficacy outcomes based on programmed death ligand 1 (PD-L1) scoring techniques in patients with head and neck squamous cell carcinoma (HNSCC) from KEYNOTE-040. Annals Of Oncology 2019, 30: v452-v453. DOI: 10.1093/annonc/mdz252.007.Peer-Reviewed Original ResearchTumor proportion scoreSecond-line treatmentSubsidiary of MerckMerck SeronoPD-L1Dohme Corp.Boehringer IngelheimTrial conductEfficacy outcomesMerck SharpEfficacy resultsDeath ligand 1 (PD-L1) expressionNeck squamous cell carcinomaGenentech/RocheObjective response rateSecond-line therapyLigand 1 expressionPD-L1 expressionPD-L1 statusProgression-free survivalSquamous cell carcinomaStandard of careSimilar survival resultsExpression levelsEuropean Medicines Agency