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 indexHNSCCPatients
2019
Pembrolizumab alone or with chemotherapy versus cetuximab with chemotherapy for recurrent or metastatic squamous cell carcinoma of the head and neck (KEYNOTE-048): a randomised, open-label, phase 3 study
Burtness B, Harrington KJ, Greil R, Soulières D, Tahara M, de Castro G, Psyrri A, Basté N, Neupane P, Bratland Å, Fuereder T, Hughes BGM, Mesía R, Ngamphaiboon N, Rordorf T, Ishak W, Hong RL, Mendoza R, Roy A, Zhang Y, Gumuscu B, Cheng JD, Jin F, Rischin D, Investigators K, Lerzo G, Tatangelo M, Varela M, Zarba J, Boyer M, Gan H, Gao B, Hughes B, Mallesara G, Rischin D, Taylor A, Burian M, Fuereder T, Greil R, Barrios C, de Castro D, Castro G, Franke F, Girotto G, Lima I, Nicolau U, Pinto G, Santos L, Victorino A, Chua N, Couture F, Gregg R, Hansen A, Hilton J, McCarthy J, Soulieres D, Ascui R, Gonzalez P, Villanueva L, Torregroza M, Zambrano A, Holeckova P, Kral Z, Melichar B, Prausova J, Vosmik M, Andersen M, Gyldenkerne N, Jurgens H, Putnik K, Reinikainen P, Gruenwald V, Laban S, Aravantinos G, Boukovinas I, Georgoulias V, Psyrri A, Kwong D, Al-Farhat Y, Csoszi T, Erfan J, Horvai G, Landherr L, Remenar E, Ruzsa A, Szota J, Billan S, Gluck I, Gutfeld O, Popovtzer A, Benasso M, Bui S, Ferrari V, Licitra L, Nole F, Fujii T, Fujimoto Y, Hanai N, Hara H, Matsumoto K, Mitsugi K, Monden N, Nakayama M, Okami K, Oridate N, Shiga K, Shimizu Y, Sugasawa M, Tahara M, Takahashi M, Takahashi S, Tanaka K, Ueda T, Yamaguchi H, Yamazaki T, Yasumatsu R, Yokota T, Yoshizaki T, Kudaba I, Stara Z, Ishak W, Cheah S, Ponce J, Mendoza R, Hernandez C, Soto F, Buter J, Hoeben A, Oosting S, Suijkerbuijk K, Bratland A, Brydoey M, Alvarez R, Mas L, Caguioa P, Querol J, Regala E, Tamayo M, Villegas E, Kawecki A, Karpenko A, Klochikhin A, Smolin A, Zarubenkov O, Goh B, Cohen G, du Toit J, Jordaan C, Landers G, Ruff P, Szpak W, Tabane N, Brana I, Docampo L, Lavernia J, Mesia R, Abel E, Muratidu V, Nielsen N, Cristina V, Rordorf T, Rothschild S, Hong R, Wang H, Yang M, Yeh S, Yen C, Ngamphaiboon N, Soparattanapaisarn N, Sriuranpong V, Aksoy S, Cicin I, Ekenel M, Harputluoglu H, Ozyilkan O, Harrington K, Agarwala S, Ali H, Alter R, Anderson D, Bruce J, Burtness B, Campbell N, Conde M, Deeken J, Edenfield W, Feldman L, Gaughan E, Goueli B, Halmos B, Hegde U, Hunis B, Jotte R, Karnad A, Khan S, Laudi N, Laux D, Martincic D, McCune S, McGaughey D, Misiukiewicz K, Mulford D, Nadler E, Neupane P, Nunnink J, Ohr J, O'Malley M, Patson B, Paul D, Popa E, Powell S, Redman R, Rella V, Lima C, Sivapiragasam A, Su Y, Sukari A, Wong S, Yilmaz E, Yorio J. Pembrolizumab alone or with chemotherapy versus cetuximab with chemotherapy for recurrent or metastatic squamous cell carcinoma of the head and neck (KEYNOTE-048): a randomised, open-label, phase 3 study. The Lancet 2019, 394: 1915-1928. PMID: 31679945, DOI: 10.1016/s0140-6736(19)32591-7.Peer-Reviewed Original ResearchConceptsCombined positive scoreSecond interim analysisProgression-free survivalPD-L1 combined positive scoreAppropriate first-line treatmentFirst-line treatmentOverall survivalSquamous cell carcinomaChemotherapy groupMetastatic HNSCCInterim analysisAdverse eventsAlone groupCell carcinomaFinal analysisCell death ligand 1 (PD-L1) expressionDeath ligand 1 (PD-L1) expressionMetastatic squamous cell carcinomaNeck squamous cell carcinomaCause adverse eventsPD-L1 positivityLigand 1 expressionPD-L1 expressionTotal populationIncurable recurrent1115PD 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