Libtayo® (cemiplimab) Plus Chemotherapy Results at Five Years Reinforce Significant and Durable Improvements in Survival Outcomes for Advanced Non-small Cell Lung Cancer

Core Insights - Regeneron Pharmaceuticals announced five-year follow-up results from the Phase 3 EMPOWER-Lung 3 trial, showing that Libtayo (cemiplimab) combined with chemotherapy significantly improves overall survival rates in patients with advanced non-small cell lung cancer (NSCLC) [1][2][4] - The trial demonstrated a five-year overall survival rate of 19.4% for the Libtayo combination compared to 8.8% for chemotherapy alone, indicating a substantial clinical benefit [1][4] - Notable efficacy was observed across different tumor histologies, particularly in squamous NSCLC patients, who had a median overall survival of 22.3 months [2][4] Summary by Sections Trial Results - The EMPOWER-Lung 3 trial involved 466 patients with locally advanced or metastatic NSCLC, comparing Libtayo plus platinum-based chemotherapy to chemotherapy alone [6][8] - The five-year analysis showed a median overall survival of 21.1 months for the Libtayo group versus 12.9 months for chemotherapy alone, representing a 34% reduction in the risk of death [4] - The median progression-free survival was 8.2 months for the Libtayo combination compared to 5.5 months for chemotherapy, indicating a 42% reduction in disease progression risk [4] Safety Profile - The safety profile of Libtayo plus chemotherapy remained consistent over five years, with adverse events occurring in 96.5% of patients receiving the combination [3][5] - Common adverse events included anemia (46%), alopecia (38%), and nausea (25%), with 49% of adverse events being grade 3 or higher [3][5] Efficacy Across Subgroups - Exploratory subgroup analyses indicated survival benefits for patients treated with Libtayo plus chemotherapy regardless of tumor histology or PD-L1 expression level [3] - The objective response rate was 43.6% for the Libtayo combination compared to 22.1% for chemotherapy alone, with a complete response rate of 6.4% versus 0% [4] Company Overview - Regeneron is focused on developing innovative therapies for serious diseases, with Libtayo being a key asset in its oncology pipeline [10][26] - The company utilizes its proprietary VelocImmune technology to create fully human monoclonal antibodies, including Libtayo, which targets the PD-1 immune checkpoint [12][25]