Nivolumab for refractory metastatic squamous non-small-cell lung cancer: fulfilling an unmet need

Lung cancer is the leading cause of cancer death in the United States and worldwide (1,2). Approximately 85% of cases involve non-small-cell lung cancer (NSCLC), of which 30% will be squamous cell histology. Of those squamous cell lung cancers diagnosed yearly, it is estimated that more than 50% are metastatic at diagnosis. Until recently, the recommended treatment for good performance status patients with metastatic squamous lung cancer consisted of first-line platinum doublet chemotherapy followed, upon disease progression, by second-line single agent chemotherapy (1). Median overall survival from initial diagnosis of metastatic squamous lung cancer in patients who receive first-line platinum doublet chemotherapy ranges from 8-11 months (3,4). Therefore, effective new therapies are desperately needed. Building upon durable objective responses to the anti-programmed death-1 (anti-PD-1) antibody, nivolumab, reported in phase I studies, Rizvi et al. have recently published the results of a singlearm phase II trial of single-agent nivolumab in pretreated metastatic squamous lung cancer (5). In conjunction with headline results from a randomized phase III trial in secondline metastatic squamous lung cancer confirming improved OS for nivolumab compared with docetaxel, these data have led to the FDA approval of nivolumab for the treatment of metastatic squamous lung cancer after prior platinum-based chemotherapy (6).