The European Commission (EC) has granted approval for Regeneron's Libtayo (cemiplimab) as monotherapy for adult patients with recurrent or metastatic cervical cancer who have experienced disease progression during or after platinum-based chemotherapy. This landmark approval establishes Libtayo as the first immunotherapy authorized in Europe for advanced cervical cancer treatment, regardless of PD-L1 expression or tumor histology.
Significant Clinical Trial Results
The approval stems from the groundbreaking EMPOWER-Cervical 1 trial, a global phase 3 study involving 608 patients across 14 countries. The study, conducted in collaboration with the GOG Foundation, ENGOT, and NRG Oncology-Japan, demonstrated compelling efficacy results. Patients receiving Libtayo showed a 31% reduction in death risk compared to those on standard chemotherapy, leading to an early trial termination due to overwhelming positive results.
"Libtayo was the first PD-1 inhibitor to demonstrate significant improvements in survival compared to chemotherapy in a phase 3 trial," noted Dr. Israel Lowy, senior vice president of translational and clinical sciences in Oncology at Regeneron.
Understanding the Disease Burden
Cervical cancer represents a significant global health challenge as the fourth leading cause of cancer death in women worldwide. The disease typically affects younger women, with most diagnoses occurring between ages 35 and 44. Approximately 600,000 new cases are diagnosed annually, resulting in 350,000 deaths. Human papillomavirus (HPV) infection causes almost all cases, with about 80% classified as squamous cell carcinoma (SCC).
Treatment Mechanism and Trial Design
Libtayo functions as a fully human monoclonal antibody targeting the PD-1 immune checkpoint receptor on T-cells. In the pivotal trial, patients (median age 51 years) were randomized to receive either 350mg Libtayo every three weeks or conventional chemotherapy options including permetrexed, vinorelbine, topotecan, irinotecan, or gemcitabine.
Professor Ignace Vergote from University Hospitals Leuven, serving as vice-chair of the Trial Steering Committee, emphasized the treatment's significance: "Libtayo is an important advancement for patients with recurrent or metastatic cervical cancer whose disease has progressed following platinum-based chemotherapy and could offer a new standard of care in this setting."
Expanded Treatment Portfolio
This approval significantly broadens Libtayo's therapeutic scope in the European Union. The drug is now approved for treating four distinct cancer types: advanced squamous cell carcinoma (SCC), advanced basal cell carcinoma (BCC), advanced cutaneous squamous cell carcinoma (CSCC), and advanced non-small cell lung cancer (NSCLC). The trial results supporting this approval were published in the prestigious New England Journal of Medicine, further validating the treatment's clinical significance.
