Dr. Camidge on the FDA Approval of Pembrolizumab for Squamous NSCLC

D. Ross Camidge, MD, PhD, a professor of medical oncology at the University of Colorado, discusses the FDA approval of first-line pembrolizumab (Keytruda) in combination with carboplatin with paclitaxel or nab-paclitaxel (Abraxane) for the treatment of patients with metastatic squamous non—small cell lung cancer (NSCLC).

This approval was based on findings from the KEYNOTE-407 trial. In this phase III trial, the combination of pembrolizumab to chemotherapy reduced the risk of death by 36% compared with chemotherapy alone in patients with metastatic squamous NSCLC. The median overall survival (OS) was 15.9 months (95% CI, 13.2 — not evaluable) with pembrolizumab versus 11.3 months (95% CI, 9.5-14.8) with chemotherapy alone (HR, 0.64; 95% CI, 0.49-0.85; P = .0017). OS benefit was observed regardless of PD-L1 expression level, choice of taxane, age, sex, and ECOG performance status.

The median progression-free survival (PFS) was 6.4 months (95% CI, 6.2-8.3) with pembrolizumab compared with 4.8 months (95% CI, 4.3-5.7) with chemotherapy alone (HR, 0.56; 95% CI, 0.45-0.70; P <.0001). While the PFS benefit was also observed across all PD-L1 expression levels, there was a correlation between an increase in PD-L1 level and a greater magnitude of benefit. Additionally, the objective response rate in the pembrolizumab arm was 57.9%, comprising a complete response rate of 1.4% and a partial response rate of 56.5%.