Pembrolizumab for Non–Small-Cell Lung Cancer

Anti–PD-1 (programmed cell death 1) and anti–PD-L1 (PD-1 ligand) antibodies have been shown to produce response in some patients with advanced non–small-cell lung cancer (NSCLC). Now, investigators have conducted an industry-funded, international, phase I study (KEYNOTE-001) to test the safety and antitumor activity of the anti–PD-1 antibody pembrolizumab in 495 patients with NSCLC. They also sought to identify a tumor PD-L1 expression level associated with pembrolizumab benefit.

Patients received intravenous pembrolizumab at doses of 2 mg/kg or 10 mg/kg every 3 weeks or 10 mg/kg every 2 weeks. Results were as follows:

• The main adverse effects were neither dose- nor schedule-dependent and included fatigue, pruritus, and diminished appetite. I…