Nivolumab for second-line treatment of metastatic squamous non-small-cell lung cancer.

PURPOSE: The pharmacokinetics, pharmacodynamics, efficacy, toxicity, and place in therapy of nivolumab, a novel immunotherapy agent for the treatment of advanced non-small-cell lung cancer (NSCLC) of the squamous cell subtype are reviewed.

SUMMARY: Nivolumab is a novel programmed cell death 1 (PD-1) immune checkpoint inhibitor indicated as a second-line treatment for patients with NSCLC whose tumors exhibit squamous cell histology. Nivolumab has high affinity for the PD-1 receptor, and durable responses to treatment have been reported in clinical trials. In a Phase II study evaluating the drug's safety and efficacy in patients who had disease progression despite treatment with platinum-based doublet chemotherapy and at least one additional systemic therapy, nivolumab-treated patients had an objective response rate of 14.5%, with a 17% rate of grade 3 or 4 treatment-related adverse events; overall survival at one year was 40.8%. A head-to-head comparison of docetaxel and nivolumab for second-line treatment of squamous cell NSCLC demonstrated superior overall survival and reduced grade 3 or 4 adverse effects in nivolumab-treated patients.

CONCLUSION: Nivolumab is a novel PD-1 immune checkpoint inhibitor that is effective for treating advanced squamous NSCLC in patients previously treated with platinum-based doublet chemotherapy or alternative first-line agents. Based on its improved efficacy and lower toxicity relative to docetaxel, nivolumab should be considered standard second-line therapy for this population.