Libtayo Significantly Enhances Five-Year Survival for Advanced Nonsmall Cell Lung Cancer Patients, Regeneron Says

New findings shared by Regeneron Pharmaceuticals, Inc. at the 2024 World Conference of Lung Cancer meeting earlier this month showed that Libtayo (cemiplimab) provides a significant long-term survival advantage at five years for patients with advanced nonsmall cell lung cancer.

Specifically, Libtayo monotherapy nearly doubled the median overall survival and lowered the risks of death and disease progression by 41% and 50%, respectively, compared with chemotherapy, according to the company.

These results come from the final prespecified overall survival analysis of the Phase 3 EMPOWER-Lung 1 trial, which compared Libtayo’s monotherapy with chemotherapy as a first-line treatment for adults with advanced nonsmall cell lung cancer who have 50% or programmed cell death ligand 1 (PD-L1) expression and do not exhibit alterations in the EGFR, ALK, or ROS1 genes. PD-L1 is protein that is often compared to a brake that keeps the body’s immune responses under control. Libtayo is one of many "immune checkpoint inhibitors" that act on immune system cells so they recognize and attack cancer.

Ana Baramidze, M.D., head of clinical research department at the Todua Clinic in Tbilisi, Georgia, noted these enlightening results showcase the durable survival benefit and impressive efficacy of first-line Libtayo monotherapy, including a direct correlation between survival benefits and PD-L1 expression level.

“Furthermore, EMPOWER-Lung 1 continues to offer important new data to help doctors increase their understanding of investigational treatment strategies for patients who progress on PD-1 inhibitor monotherapy,” she said at the conference. “For instance, EMPOWER-Lung 1 was one of the few trials to evaluate survival when adding chemotherapy to a PD-1 inhibitor following progression.”

Previously, a one-year analysis was published in The Lancet in February 2021, but the latest findings demonstrate significantly more promising results.

In the EMPOWER-Lung 1 trial, patients who experienced disease progression were allowed to change their treatment; those initially assigned to Libtayo had the option to add four cycles of chemotherapy. At the five-year follow-up, patients who received the combination therapy showed a median overall survival of 15 months (95% CI: 11 to 18 months), a median progression-free survival of 7 months (95% CI: 6 to 8 months), and an objective response rate of 28% (95% CI: 18% to 40%).

Furthermore, exploratory subgroup analysis of EMPOWER-Lung 1 revealed direct correlations between survival and disease progression benefits and PD-L1 expression level among Libtayo patients, supporting the direct correlation between tumor response and PD-L1 expression level previously observed.

Regeneron Pharmaceuticals noted the potential use of adding chemotherapy to Libtayo following disease progression is still considered investigational, and the safety and efficacy of this regimen have not been fully evaluated by any regulatory authority.