Pembrolizumab for Non–Small-Cell Lung Cancer

Following publication of the phase Ib KEYNOTE-001 study (NEJM JW Oncol Hematol Jun 2015, and N Engl J Med 2015; 372:2018), pembrolizumab (MK-3475), an IgG4 monoclonal antibody to PD-1, was granted accelerated FDA approval for evaluation in chemorefractory non–small-cell lung cancer (NSCLC) that expresses PD-L1.

Now, investigators have conducted an industry-funded, international phase II/III, randomized, controlled, open-label trial (KEYNOTE-010), in which previously treated NSCLC patients who expressed PD-L1 in at least 1% of tumor cells received one of three treatments: pembrolizumab (2 mg/kg), pembrolizumab (10 mg/kg), or docetaxel (75 mg/m²).

Results were as follows:

• For the entire study population, median overall survival (OS) was improved…