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


CONCLUSIONS
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.


CONCLUSIONS
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.
Amanda Rounds is a Pharm.D. student, School of Pharmacy, University of Wisconsin (UW), Madison. Jill Kolesar, Pharm.D., BCPS, FCCP, is Professor, School of Pharmacy, UW, and Faculty Supervisor, Analytical Laboratory for Pharmacokinetics, Pharmacodynamics and Pharmacogenomics, UW Carbone Comprehensive Cancer Center, Madison.
Amanda
A
Rounds
Amanda Rounds is a Pharm.D. student, School of Pharmacy, University of Wisconsin (UW), Madison. Jill Kolesar, Pharm.D., BCPS, FCCP, is Professor, School of Pharmacy, UW, and Faculty Supervisor, Analytical Laboratory for Pharmacokinetics, Pharmacodynamics and Pharmacogenomics, UW Carbone Comprehensive Cancer Center, Madison. jill.kolesar@wisc.edu.
Jill
J
Kolesar
D000911:Antibodies, Monoclonal / Q000191:economics / Q000627:therapeutic use*; D000970:Antineoplastic Agents / Q000191:economics / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy*; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy*; D002986:Clinical Trials as Topic; D017321:Clinical Trials, Phase I as Topic; D017322:Clinical Trials, Phase II as Topic; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy*; D000077594:Nivolumab
D000911:Antibodies, Monoclonal; D000970:Antineoplastic Agents; D000077594:Nivolumab