A phase III comparative study of nivolumab (anti-PD-1; BMS-936558; ONO-4538) versus docetaxel in patients with previously treated advanced or metastatic squamous cell non-small cell lung cancer (NSCLC).

TPS8122 Background: NSCLC is the leading cause of cancer death worldwide, exceeding breast, colon and prostate cancer combined. Most patients (pts) are diagnosed with advanced/recurrent disease. NSCLC therapies have incrementally improved overall survival (OS), but benefit has reached a plateau (median OS for late stage pts is just 1 yr). Squamous cell carcinoma (SCC) represents one quarter of NSCLC cases and has limited treatment options. Pemetrexed and bevacizumab are not approved in SCC, and molecularly targeted therapies have limited application. Single-agent chemotherapy is standard of care following progression with platinum-based doublet chemotherapy (Pt-doublet), resulting in median OS of approximately 7 months. Immune checkpoint blockade in NSCLC may promote tumor regression by reversing tumor-induced immunosuppression and restoring the antitumor immune response. Programmed death-1 (PD-1), an immune checkpoint receptor that negatively regulates T-cell activation, is upregulated in tumor infiltrat...