Dr. Garon on the KEYNOTE-001 Study in NSCLC

Edward B. Garon, MD, MS, associate professor of medicine, David Geffen School of Medicine, University of California, Los Angeles, discusses the KEYNOTE-001 study, which examined the 5-year long-term overall survival (OS) in patients with non—small cell lung cancer (NSCLC) treated with pembrolizumab (Keytruda).

The KEYNOTE-001 study was the original study of pembrolizumab, according to Garon. However, it was unlike other first-in-human studies because it enrolled over 1000 patients and led to the initial approvals in melanoma and NSCLC, explained Garon. It also led to approval for an assay to look at PD-L1 expression.

The study showed that the 5-year OS rate was 23.2% in treatment-naïve patients and 15.5% in previously treated patients. The study also showed that the clinical benefit appeared to correlate well with PD-L1 expression, particularly with the best outcomes being amongst patients who had PD-L1 expression in at least half of their tumor cells, according to Garon. The 5-year OS rate in patients with high levels of PD-L1 expression was 29.6% in treatment-naïve patients and 25% in previously treated patients.