Nivolumab vs investigator's choice in recurrent or metastatic squamous cell carcinoma of the head and neck: 2-year long-term survival update of CheckMate 141 with analyses by tumor PD-L1 expression ORAL ONCOLOGY Ferris, R. L., Blumenschein, G., Fayette, J., Guigay, J., Colevas, A., Licitra, L., Harrington, K. J., Kasper, S., Vokes, E. E., Even, C., Worden, F., Saba, N. F., Iglesias Docampo, L., Haddad, R., Rordorf, T., Kiyota, N., Tahara, M., Lynch, M., Jayaprakash, V., Li, L., Gillison, M. L. 2018; 81: 45–51

Abstract

We report 2-year results from CheckMate 141 to establish the long-term efficacy and safety profile of nivolumab and outcomes by tumor PD-L1 expression in patients with recurrent or metastatic (R/M),platinum-refractory squamous cell carcinoma of the head and neck (SCCHN).Patients with R/M SCCHN with tumor progression/recurrence within 6?months of platinum therapy were randomized 2:1 to nivolumab 3?mg/kg every 2?weeks or investigator's choice (IC). Primary endpoint: overall survival (OS). Data cutoff: September 2017.With 24.2?months' minimum follow-up, nivolumab (n?=?240) continued to improve OS vs IC (n?=?121), hazard ratio (HR)?=?0.68 (95% CI 0.54-0.86). Nivolumab nearly tripled the estimated 24-month OS rate (16.9%) vs IC (6.0%), and demonstrated OS benefit across patients with tumor PD-L1 expression =1% (HR [95% CI]?=?0.55 [0.39-0.78]) and ?

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