Regeneron Pharmaceuticals has shared positive five-years results from a late-stage study of Libtayo (cemiplimab) in advanced lung cancer.
The phase 3 EMPOWER-Lung 1 trial compared the monoclonal antibody to chemotherapy as a first-line treatment for advanced non-small cell lung cancer (NSCLC) in adults with at least 50% PD-L1 expression and no EGFR, ALK or ROS1 aberrations.
The results from the final pre-specified overall survival (OS) analysis of the study were presented at this year’s World Conference on Lung Cancer and demonstrated durable survival benefits for Libtayo.
At the five-year follow-up of this patient population, a median OS of 26 months was seen in the Libtayo treatment group, compared to 13 months in the chemotherapy cohort.
Median progression-free survival for Libtayo was eight months, compared to five months for chemotherapy, and patients receiving Regeneron’s drug also demonstrated an objective response rate of 46.5%, compared to 21% for chemotherapy.
Continued and clinically meaningful benefits were also observed at the five-year follow-up of the overall trial population, in which not all patients were confirmed to have at least 50% PD-L1 expression, and no new safety signals were observed at five years among evaluable patients.
Ana Baramidze, head of clinical research department at Todua Clinic, said: “The five-year results from EMPOWER-Lung 1 showcase the durable survival benefit and impressive efficacy of first-line Libtayo monotherapy compared to chemotherapy in patients with PD-L1 high, advanced NSCLC, including a direct correlation between survival benefits and PD-L1 expression level.”
Lung cancer is the leading cause of cancer-related deaths globally and NSCLC accounts for up to 85% of all diagnoses.
Libtayo has been shown to block cancer cells from using the PD-1 pathway to suppress T-cell activation and already holds approvals to treat certain cases of NSCLC, both as a monotherapy and in combination with platinum-containing chemotherapy.
Beyond NSCLC, the therapy is also authorised to treat cutaneous squamous cell carcinoma and basal cell carcinoma.
The latest results come just two weeks after Regeneron’s Ordspono (odronextamab) was approved by the European Commission to treat two common subtypes of non-Hodgkin lymphoma.