The safety and efficacy of nivolumab for the treatment of advanced renal cell carcinoma.

INTRODUCTION: Despite a variety of therapies for advanced advanced renal cell carcinoma (RCC) including vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitors (TKIs) and mammalian target of rapamycin (mTOR) inhibitors, outcomes for these patients are still not optimal. Immunotherapy with checkpoint inhibitors such as nivolumab, a fully human immunoglobulin (Ig) G4 PD-1 inhibitor antibody, is a promising development in RCC and provides a new therapeutic option for patients with advanced disease. AREAS COVERED: This article reviews safety and efficacy data from the phase I, II, and III clinical trials that have led to the approval of nivolumab for the treatment of patients with advanced RCC who have previously been treated with VEGF-directed therapy. Expert Commentary: Given the overall survival advantage with nivolumab compared to previously approved therapy, nivolumab is a new standard of care in the second-line setting for patients with advanced RCC. Additional studies are underway to answer important questions including the identification of biomarkes and the use of nivolumab in treatment-naïve patients.