A joint profile of cytokines and immune cell populations may identify HNSCC patients who benefit from nivolumab treatment. The Gruppo Oncologico Nord-Ovest (GONO) study Nivactor T-2

Abstract Background : Immunotherapy of head and neck cancer induces a limited but reproducible rate of long-term survivors, at the cost of treating a large number of patients exposed to toxicity without benefit, regardless of PD-L1 expression. Therefore, identification of better markers for response is an unmet need. Materials and methods : 18 cytokines and 24 subpopulations of immune cells, selected on their prevalent Th1 or Th2 effect, were collected from peripheral blood. Samples were gathered at baseline (T0) and after 3 courses of nivolumab (T1) in 22 head and neck cancer patients, refractory to platinum containing therapy or in second line treatment for relapsed/metastatic disease. Data extracted at each time point have been linked to overall survival. A threshold value able to discriminate between good or poor survival, have been identified by ROC analysis. The relative value of the most promising cytokines/immune cells was determined by PCA. Results: at T0, 4 cytokines (IL-6, IL-8, IL-10, TGF-β) and 2 immune cells (CD3 + CD8 + LAG3 + , CD3 + CD11 + HLA-DR low CD14 - ) were able to discriminate between good and poor survival and allowed the identification of two clusters of patients. Conclusion: with the limitation of an exploratory analysis, this report suggests that a mixed profile of cytokine and immune cells determined at baseline, is potentially able to discriminate between patients who will benefit from nivolumab treatment and those who will do not.