���Improvement in overall survival is the ultimate objective in the treatment of advanced lung cancer. KEYNOTE-042 is the first randomized Phase 3 study of a single-agent immunotherapy using overall survival as the primary endpoint that has demonstrated significant benefit as first-line therapy in NSCLC patients who tested positive for PD-L1 at 1 percent or higher.���

~Prof. Tony SK Mok, Department of Clinical Oncology, the Chinese University of Hong Kong

The primary endpoint OS in the KEYNOTE-042 study was sequentially tested and of statistical significance in subsets of patients with a PD-L1 TPS ���50%, PD-L1 TPS ���20%, and in the entire study population with a PD-L1 TPS ���1%. Safety data of pembrolizumab��was reported similar to prior single-agent studies of the PD-1 immunotherapy in advanced NSCLC.

KEYNOTE-024 in PD-L1 ���50% expression

Previously, the Phase 3 KEYNOTE-024 study showed the drug to more than double the OS in the frontline setting for patients with Stage IIIb and IV NSCLC and a TPS ���50% when compared to platinum-based chemotherapy (Figure 1). Based on the results of this KEYNOTE-024 trial, the United States Food and Drug Administration (US FDA) approved pembrolizumab��for��1st-line treatment of patients with metastatic NSCLC of any histology, negative EGFR and ALK status, and a PD-L1 TPS ���50%��in October 2016.

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Figure 1. The KEYNOTE-024 in patients with any histology NSCLC, a negative EGFR and ALK status, and a PD-L1 TPS ���50% resulted in a 37% reduction for risk of death favouring pembrolizumab when compared to chemotherapy (HR=0.63, P=0.002; 95% CI=0.47-0.86).