Low OT-NLR predicts superior survival in recurrent/metastatic HNSCC treated with cetuximab plus nivolumab

This Phase II clinical trial investigated patients with recurrent and/or metastatic head and neck squamous cell carcinoma (HNSCC) treated with the combination of cetuximab and nivolumab. The study analyzed the association between peripheral blood OT-NLR levels and clinical outcomes over a follow-up period of 24.0 months. The primary outcome was overall survival (OS), with secondary outcomes including progression-free survival (PFS) and overall response. Safety and tolerability data were not reported in this publication.

Patients with low OT-NLR demonstrated superior overall survival compared with those with high OT-NLR, with a hazard ratio (HR) of 0.32 (95% CI, 0.17-0.61). Similarly, low OT-NLR was associated with superior progression-free survival (HR 0.45; 95% CI, 0.25-0.81) and superior overall response (P <0.001). A higher proportion of patients with low OT-NLR achieved OS of 24 months or longer compared with high OT-NLR (P =0.0001). Additionally, low pretreatment T-NLR correlated with superior overall response (P =0.011). Absolute numbers for these outcomes were not reported.

No specific adverse events, serious adverse events, discontinuations, or tolerability data were reported in the input. The study did not report funding sources or conflicts of interest. Key limitations include the lack of a comparator arm and the absence of absolute numbers for survival and response rates. The observational nature of the biomarker analysis precludes causal conclusions regarding the drug regimen itself.

Further evaluation of T-NLR to improve patient selection and peripheral blood OT-NLR as a dynamic biomarker contributing to clinical benefit assessment given cetuximab and nivolumab is warranted. Clinicians should interpret these results as exploratory associations rather than definitive predictors of treatment efficacy in this specific setting.