Multicenter phase 2 trial of cetuximab plus nivolumab for recurrent/metastatic head and neck squamous cell carcinoma: long-term outcomes

A multicenter phase 2 trial in the USA evaluated the combination of cetuximab and nivolumab in patients with recurrent or metastatic head and neck squamous cell carcinom (R/M HNSCC). Long-term outcomes of the trial have now been published. At a median follow-up of 47.4 months, the median overall survival and 2-year OS rate were 12.7 months and 32% in all evaluable patients (n=88) and 17.5 months and 35% in patients who had no previous therapy for R/M HNSCC (n=43). The survival efficacy was similar between patients with p16-negative and p16-positive tumors, but the response rate was significantly higher in patients with p16-negative tumors, as were clonal tumor mutational burden, hypoxia score, and EGFR pathway score. Loss of heterozygosity of MHC class I was significantly more frequent in nonresponders, whereas APOBEC-associated mutagenesis was elevated in responders. The authors conclude that long-term follow-up of the study indicated that the combination of cetuximab and nivolumab is efficacious and tolerable among patients with R/M HNSCC.