Regeneron’s PD-1 inhibitor Libtayo (cemiplimab) has been approved by the European Commission (EC) as monotherapy for the treatment of adult patients with recurrent or metastatic cervical cancer and disease progression on or after platinum-based chemotherapy, the company announced.
The approval is based on results from the global phase 3 trial, EMPOWER-Cervical 1, that evaluated Libtayo in comparison to an investigator’s choice of chemotherapy. The trial enrolled 608 patients across 14 countries, irrespective of PD-L1 expression status or histology.
Results demonstrated that those treated with Libtayo compared to chemotherapy experienced significant improvements in overall survival, progression-free survival and objective response rate.
This included a 31% reduction in the risk of death and a longer median overall survival in the overall population, with patients receiving Libtayo achieving a 12-month overall survival, versus 8.5 months in those receiving chemotherapy.
The significant improvement in overall survival, which was the primary endpoint of the trial, was the basis for the Independent Data Monitoring Committee’s recommendation that the trial be stopped early.
Cervical cancer is the fourth leading cause of cancer death in women worldwide and is most frequently diagnosed between the ages of 35 and 44. Approximately 600,000 new cases of cervical cancer and 350,000 deaths from cervical cancer occur worldwide each year.
Human papillomavirus (HPV) infection accounts for nearly all cervical cancer cases, with approximately 80% classified as squamous cell carcinoma and the remainder largely adenocarcinomas. Cervical cancer is often curable when detected early and effectively managed, but treatment options are more limited in advanced stages.
“Despite recent advancements in the prevention and treatment of cervical cancer, there remain limited options for people with recurrent or metastatic cases,” said Israel Lowy, senior vice president, translational and clinical sciences, oncology at Regeneron.
“Libtayo was the first PD-1 inhibitor to demonstrate significant improvements in survival compared to chemotherapy in a phase 3 trial. With this fourth approval from the EC, Libtayo can now be extended to appropriate patients in the EU with advanced cervical cancer, irrespective of their PD-L1 status or histology,” he added.
Libtayo is also approved in the EU for the treatment of certain patients with advanced basal cell carcinoma, advanced cutaneous squamous cell carcinoma and advanced non-small cell lung cancer.
Commenting on the most recent EU approval, Professor Ignace Vergote, investigator and gynaecologist oncologist at University Hospitals Leuven in Belgium, and vice-chair of the Trial Steering Committee, said: “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.”