Libtayo demonstrates lasting survival benefits in phase 3 lung cancer study

Regeneron Pharmaceuticals has announced promising five-year findings from a pivotal study of its drug Libtayo (cemiplimab) in advanced lung cancer. The phase 3 EMPOWER-Lung 1 trial evaluated the efficacy of this monoclonal antibody compared to traditional chemotherapy as an initial treatment for advanced non-small cell lung cancer (NSCLC) in adults displaying at least 50% PD-L1 expression and lacking EGFR, ALK, or ROS1 mutations.

Detailed at the recent World Conference on Lung Cancer, the final pre-determined overall survival (OS) analysis revealed that Libtayo delivers durable survival advantages. Specifically, the five-year follow-up showed that patients treated with Libtayo had a median OS of 26 months, while those in the chemotherapy group had a median OS of 13 months. Furthermore, median progression-free survival for Libtayo was eight months, in contrast to five months for those receiving chemotherapy. In terms of objective response rate, Libtayo achieved 46.5%, compared to 21% for chemotherapy.

The comprehensive benefits of Libtayo persisted through the five-year follow-up across the entire trial population, even for patients not confirmed to have at least 50% PD-L1 expression. Importantly, no new safety concerns emerged over the five years among evaluable patients.

Ana Baramidze, head of clinical research at Todua Clinic, emphasized the significance of these findings, stating, "The five-year results from EMPOWER-Lung 1 highlight the durable survival benefit and notable efficacy of first-line Libtayo monotherapy compared to chemotherapy in patients with high PD-L1 expression and advanced NSCLC. There is a clear correlation between survival benefits and PD-L1 expression levels."

Lung cancer remains the leading cause of cancer-related mortality worldwide, with NSCLC accounting for up to 85% of all cases. Libtayo has demonstrated its ability to inhibit cancer cells from exploiting the PD-1 pathway to deactivate T-cells. The drug is already approved for treating specific NSCLC cases, either alone or combined with platinum-based chemotherapy. Beyond NSCLC, Libtayo is also authorized for treating cutaneous squamous cell carcinoma and basal cell carcinoma.

These latest findings come shortly after another significant milestone for Regeneron. Just two weeks ago, the European Commission approved Regeneron's Ordspono (odronextamab) for treating two common subtypes of non-Hodgkin lymphoma.

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