Regeneron Pharmaceuticals has released five-year positive results from the Phase 3 EMPOWER-Lung 1 trial of Libtayo (cemiplimab) for advanced lung cancer.
EMPOWER-Lung 1 compared Libtayo monotherapy to chemotherapy for adults with advanced non-small cell lung cancer (NSCLC) with at least 50% PD-L1 expression and no EGFR, ALK, or ROS1 mutations.
In the US and other countries, the drug is indicated for certain patients with advanced basal cell carcinoma (BCC), advanced cutaneous squamous cell carcinoma (CSCC), and advanced NSCLC.
In the European Union, Canada, and Brazil, it is also indicated for advanced cervical cancer.
Regeneron Pharmaceuticals obtained exclusive global rights to Libtayo from Sanofi in 2022.
At the five-year follow-up, the fully human monoclonal antibody continued to outperform chemotherapy in patients.
It almost doubled median overall survival and lowered the risks of death and disease progression by 41% and 50%, respectively, in comparison to chemotherapy.
The benefits observed were consistent with those seen in the previous one-year analysis.
For patients who experienced disease progression and were initially on Libtayo, they had the option to add four cycles of chemotherapy.
Among these 75 patients, the addition of chemotherapy led to a median overall survival (OS) of 15 months, a median progression-free survival (PFS) of seven months, and an objective response rate (ORR) of 28%.
The exploratory subgroup analysis revealed that Libtayo patients with higher PD-L1 expression levels had better survival and disease progression outcomes.
Specifically, patients with tumour PD-L1 expression of ≥90% had the greatest benefit. They demonstrated a median OS of 39 months and a median PFS of 15 months.
No new safety concerns emerged at the five-year mark.
Todua Clinic in Tbilisi, Georgia clinical research department head Ana Baramidze 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.”
Libtayo is also being studied in trials both as a monotherapy and in combination with conventional or novel therapies for other solid tumours and blood cancers.
The latest findings follow Regeneron Pharmaceuticals’ European Commission approval of Ordspono in August. Ordspono is now approved to treat two common subtypes of non-Hodgkin lymphoma.
