Updated results from Phase III study of Keytruda (pembrolizumab) in non-small cell lung cancer- Merck Inc

Merck Inc announced updated overall survival (OS) findings from KEYNOTE-024, the phase III study evaluating Keytruda (pembrolizumab) as a monotherapy compared to platinum-containing chemotherapy in the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC) whose tumors express high levels of PD-L1 (tumor proportion score [TPS] of 50 percent or more). The study included patients with squamous and non-squamous NSCLC with no EGFR or ALK genomic tumor aberrations and demonstrated a reduction in the risk of death by 37 percent for Keytruda compared to chemotherapy based on 19 months of median follow-up.

Additionally, in an exploratory analysis, progression-free survival 2 (PFS2) – a clinical endpoint used to assess the impact of next-line treatment on disease control – was substantially improved for patients in the Keytruda group compared to the chemotherapy group. With approximately eight additional months of follow-up, data showed continued OS benefit with Keytruda over chemotherapy in the first-line treatment of patients with advanced NSCLC whose tumors expressed high levels of PD-L1 – showing an 18-month OS rate of 61.2 percent in the Keytruda group compared to 43.0 percent in the chemotherapy group; the 12-month OS rate was 70.3 percent in the Keytruda group compared to 54.8 percent in the chemotherapy group.

For PFS2, findings based on 19 months of median follow-up showed a 46 percent reduction in the risk of progression after the start of the second-line regimen or death in patients initially randomized to Keytruda compared to patients initially randomized to chemotherapy. These data are being presented at the 2017 American Society of Clinical Oncology (ASCO) Annual Meeting.