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

B Burtness; KJ Harrington; R Greil; D Soulières; M Tahara; G de Castro; A Psyrri; N Basté; P Neupane; Å Bratland; T Fuereder; BGM Hughes; R Mesía; N Ngamphaiboon; T Rordorf; WZ Wan Ishak; RL Hong; R González Mendoza; A Roy; Y Zhang; B Gumuscu; JD Cheng; F Jin; D Rischin; G Lerzo; M Tatangelo; M Varela; JJ Zarba; M Boyer; H Gan; B Gao; G Mallesara; A Taylor; M Burian; CH Barrios; DO de Castro Junior; G Castro; FA Franke; G Girotto; IPF Lima; UR Nicolau; GDJ Pinto; L Santos; AP Victorino; N Chua; F Couture; R Gregg; A Hansen; J Hilton; J McCarthy; R Ascui; P Gonzalez; L Villanueva; M Torregroza; A Zambrano; P Holeckova; Z Kral; B Melichar; J Prausova; M Vosmik; M Andersen; N Gyldenkerne; H Jurgens; K Putnik; P Reinikainen; V Gruenwald; S Laban; G Aravantinos; I Boukovinas; V Georgoulias; D Kwong; Y Al-Farhat; T Csoszi; J Erfan; G Horvai; L Landherr; E Remenar; A Ruzsa; J Szota; S Billan; I Gluck; O Gutfeld; A Popovtzer; M Benasso; S Bui; V Ferrari; L Licitra; F Nole; T Fujii; Y Fujimoto; N Hanai; H Hara; K Matsumoto; K Mitsugi; N Monden; M Nakayama; K Okami; N Oridate

Journal article

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

B Burtness, KJ Harrington, R Greil, D Soulières, M Tahara, G de Castro, A Psyrri, N Basté, P Neupane, Å Bratland, T Fuereder, BGM Hughes, R Mesía, N Ngamphaiboon, T Rordorf, WZ Wan Ishak, RL Hong, R González Mendoza, A Roy, Y Zhang Show all

Lancet | ELSEVIER SCIENCE INC | Published : 2019

DOI: 10.1016/S0140-6736(19)32591-7

Abstract

Background: Pembrolizumab is active in head and neck squamous cell carcinoma (HNSCC), with programmed cell death ligand 1 (PD-L1) expression associated with improved response. Methods: KEYNOTE-048 was a randomised, phase 3 study of participants with untreated locally incurable recurrent or metastatic HNSCC done at 200 sites in 37 countries. Participants were stratified by PD-L1 expression, p16 status, and performance status and randomly allocated (1:1:1) to pembrolizumab alone, pembrolizumab plus a platinum and 5-fluorouracil (pembrolizumab with chemotherapy), or cetuximab plus a platinum and 5-fluorouracil (cetuximab with chemotherapy). Investigators and participants were aware of treatment..

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