Nivolumab (Opdivo) in combination with lirilumab, an anti-killer-cell immunoglobulin-like receptor (anti-KIR) antibody, demonstrated encouraging clinical benefit for patients with advanced squamous cell carcinoma of the head and neck (HNSCC) refractory to platinum-based therapy, according to interim data presented at the Society for Immunotherapy of Cancer (SITC) 31 Annual Meeting in National Harbor, Maryland.1

Among 29 evaluable patients with HNSCC treated with nivolumab and lirilumab, 24% achieved an objective response and 17% had deep responses with reductions in tumor burden greater than 80%. Subgroup analysis showed that 41% of the 17 evaluable patients with 1% PD-L1 expression or greater achieved a response.

The safety profile associated with lirilumab in combination with nivolumab was generally consistent with that observed with nivolumab alone. About three-quarters of 159 patients included in a safety analysis experienced treatment-related adverse events; 15% reported grade 3 to 4 treatment-related adverse events.

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Immunotherapy discontinuation was required in 8% of patients due to adverse events.

RELATED: FDA Approves Nivolumab for Recurrent/Metastatic Head and Neck Cancer

For the open-label, phase 1/2 dose escalation and cohort expansion study, researchers enrolled 159 patients with advanced refractory solid tumors. Patients received 1 of 4 doses of lirilumab once every 4 weeks plus nivolumab once every 3 weeks.


  1. Interim phase 1/2 data show encouraging clinical benefit for lirilumab in combination with Opdivo (nivolumab) in patients with advanced platinum refractory squamous cell carcinoma of the head and neck. Bristol-Myers Squibb website. Updated November 12, 2016. Accessed November 16, 2016.