Burtness B, Harrington KJ, Greil R, et al. - In a randomized, phase 3 study (KEYNOTE-048) of individuals with untreated locally incurable recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) carried out at 200 sites in 37 countries, experts compared the safety and efficiency pembrolizumab alone or with chemotherapy vs cetuximab with chemotherapy in HNSCC. A total of 882 people were randomized to receive pembrolizumab alone (n = 301), pembrolizumab with chemotherapy (n = 281), or cetuximab with chemotherapy (n = 300). On the basis of the found efficiency and safety, for recurrent or metastatic HNSCC, pembrolizumab with platinum and 5-fluorouracil is a relevant first-line treatment and for programmed cell death ligand 1-positive recurrent or metastatic HNSCC, pembrolizumab monotherapy is a suitable first-line treatment.