Regeneron’s Libtayo Plus Chemotherapy Delivers 5-Year Survival Benefit In NSCLC; Combination Therapy Reduces Risk Of Death by 34%

Regeneron Pharmaceuticals, Inc. announced five-year follow-up results from the Phase 3 EMPOWER-Lung 3 trial, evaluating Libtayo® (cemiplimab) plus platinum-based chemotherapy versus chemotherapy alone as a first-line treatment for adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) without EGFR, ALK, or ROS1 aberrations. The late-breaking results were presented at the IASLC 2025 World Conference on Lung Cancer (WCLC).

With a median follow-up of 60.9 months, Libtayo plus chemotherapy maintained superiority across key efficacy measures: median overall survival (OS) of 21.1 months vs. 12.9 months for chemotherapy alone, a 34% reduction in risk of death (HR: 0.66), and a five-year survival probability of 19.4% vs. 8.8%. The combination also improved median progression-free survival (8.2 vs. 5.5 months), objective response rate (43.6% vs. 22.1%), and duration of response (16.4 vs. 7.3 months). Importantly, subgroup analyses confirmed consistent survival benefit regardless of tumor histology or PD-L1 expression.

“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 Department at Todua Clinic, Tbilisi, Georgia. “Long-term results across tumor histologies were also reported, including a notable 22.3-month median overall survival for squamous NSCLC patients. Collectively, these data underscore Libtayo’s utility across a variety of patient types, both as a single agent and in combination with chemotherapy.”

The safety profile at five years remained consistent with prior data. Adverse events of any grade were reported in 96.5% of patients on Libtayo plus chemotherapy (49% ≥Grade 3) compared with 95% on chemotherapy alone (33% ≥Grade 3). Treatment-related adverse events ≥Grade 3 occurred in 30% of Libtayo patients, leading to discontinuation in 4.5% and death in 1%, compared with 18%, 1%, and 0.7% in the chemotherapy arm, respectively. These findings build on the EMPOWER-Lung 1 trial’s five-year monotherapy data, underscoring the durable, long-term survival benefit of Libtayo in advanced NSCLC.