Regeneron Pharmaceuticals, Inc. has announced five-year follow-up results from its Phase 3 EMPOWER-Lung 3 trial, showing that Libtayo® (cemiplimab) combined with chemotherapy significantly improves survival outcomes for patients with advanced non-small cell lung cancer (NSCLC) compared with chemotherapy alone.
Data presented at the 2025 World Conference on Lung Cancer (WCLC) demonstrated that Libtayo plus chemotherapy achieved a five-year overall survival probability of 19.4% versus 8.8% with chemotherapy alone. Median overall survival was 21.1 months compared to 12.9 months, reflecting a 34% reduction in risk of death. Progression-free survival and objective response rates also improved substantially in the combination arm .
The benefit was consistent across histologies and PD-L1 expression levels. In squamous NSCLC, median overall survival was 22.3 months compared with 13.8 months for chemotherapy. In non-squamous patients, survival reached 19.4 months versus 12.4 months. For patients with PD-L1 expression ≥1%, the median overall survival was 24 months compared with 12.1 months .
“After more than five years of follow-up, the EMPOWER-Lung 3 trial continues to demonstrate sustained survival – with an impressive overall survival probability of 19.4% at five years – when Libtayo is added to chemotherapy in patients with advanced non-small cell lung cancer,” said Ana Baramidze, M.D., Ph.D., Head of Clinical Research at Todua Clinic, Georgia .
The safety profile of Libtayo plus chemotherapy remained consistent with previous reports, with adverse events largely manageable and no new safety signals identified .
About the EMPOWER-Lung 3 Trial
The global Phase 3 trial enrolled 466 patients with locally advanced or metastatic NSCLC across all PD-L1 expression levels, excluding those with EGFR, ALK or ROS1 aberrations. Patients were randomised 2:1 to receive either Libtayo plus platinum-doublet chemotherapy or chemotherapy alone .
