EC approves Regeneron's Libtayo for advanced cervical cancer

Regeneron has announced that the European Commission (EC) has approved Libtayo (cemiplimab) as a monotherapy for the treatment of adult patients with second-line recurrent or metastatic cervical cancer and disease progression on or after platinum-based chemotherapy.

The approval means that Libtayo is now the first immunotherapy approved in Europe to treat advanced cervical cancer, regardless of PD-L1 expression or tumour histology.

The fourth leading cause of cancer death in women globally, cervical cancer is most frequently diagnosed between 35 and 44 years old. Annually, approximately 600,000 new cases of cervical cancer are diagnosed, and each year 350,000 die from the disease. Almost all cases are caused by human papillomavirus (HPV) infection, with approximately 80% classified as squamous cell carcinoma (SCC); the remainder are largely adenocarcinomas. Cervical cancer is curable if detected early and effectively managed, but advanced stages have limited treatment options.

The EC approved Libtayo – a fully human monoclonal antibody targeting the immune checkpoint receptor PD-1 on T-cells – based on data from the global open-label, multi-centre phase 3 EMPOWER-Cervical 1 trial of 608 patients across 14 countries, conducted with the GOG Foundation, Inc. (GOG), the European Network for Gynaecological Oncological Trial groups (ENGOT), and NRG Oncology-Japan.

Patients were of a median age of 51 years old – 78% with SCC and 22% with adenocarcinoma or adenosquamous carcinoma – and randomised to receive 350mg Libtayo every three weeks or chemotherapy (permetrexed, vinorelbine, topotecan, irinotecan, or gemcitabine).

The trial was stopped early, following a unanimous recommendation by the Independent Data Monitoring Committee, based on the highly significant effect of Libtayo, with results that demonstrated significant overall survival (OS) benefit in patients with SCC recurrent or metastatic cervical cancer, and a 31% reduced risk of death compared to chemotherapy during the study. The results were published in the New England Journal of Medicine.

Dr Israel Lowy, senior vice president of translational and clinical sciences in Oncology at Regeneron, said: “Despite recent advancements in the prevention and treatment of cervical cancer, there remain limited options for people with recurrent or metastatic cases […] Libtayo was the first PD-1 inhibitor to demonstrate significant improvements in survival compared to chemotherapy in a phase 3 trial.”

Professor Ignace Vergote, investigator and gynaecologist oncologist at University Hospitals Leuven in Belgium, and vice-chair of the Trial Steering Committee, commented: “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.”

The EC approval also now means that Libtayo can be used to treat certain patients across four types of cancer within the European Union: advanced squamous cell carcinoma (SCC), advanced basal cell carcinoma (BCC), advanced cutaneous squamous cell carcinoma (CSCC), and advanced non-small cell lung cancer (NSCLC).

Last week, Regeneron announced a strategic research collaboration with CytomX Therapeutics within the field of conditionally activated bispecific therapeutics for the treatment of cancer.

Meanwhile, another company focused on advanced cervical cancer is Nykode Therapeutics, its VB10.16 vaccine to treatment with Roche’s cancer immunotherapy Tecentriq reported in May this year to have resulted in disease control in two-thirds of patients.