Libtayo available in Scotland for cervical cancer patients

New immunotherapy offers hope for recurrent cervical cancer

Regeneron UK Limited has announced that the Scottish Medicines Consortium (SMC) has accepted Libtayo (cemiplimab) for use on the National Health Service. This approval is for second-line monotherapy treatment of adults with recurrent or metastatic cervical cancer and disease progression after platinum-based chemotherapy.

Although cervical cancer is often curable when detected early advanced or metastatic disease has a poor prognosis and can significantly impact quality of life. Treatment options are also more limited in advanced stages. In Scotland, only 20% of women diagnosed with stage IV cervical cancer will survive five years.

James Winterman, Regeneron UK and Ireland Country Manager, Oncology, said: “The acceptance of cemiplimab by the SMC marks the availability of the first immunotherapy for recurrent or metastatic cervical cancer on or after platinum-based chemotherapy.

“This is a significant advance for women who currently have limited options. The rate of women diagnosed with cervical cancer each year is significantly higher in Scotland compared to the UK average.”

Cemiplimab is a fully human monoclonal antibody targeting the immune checkpoint receptor PD-1 on T cells. By binding to PD-1 cemiplimab has been shown to block cancer cells from using the PD-1 pathway to suppress T-cell activation.

The SMC’s acceptance is based on data from the EMPOWER-Cervical 1 phase 3 trial. This open-label multi-centre randomised trial included patients with disease progression after first-line platinum-containing chemotherapy. Patients were enrolled regardless of PD-L1 expression status.

In the trial patients treated with cemiplimab experienced a significant improvement in overall survival and objective response rate compared to those treated with chemotherapy. Median overall survival was 12 months for cemiplimab vs. 8.5 months for chemotherapy. The objective response rate was 16% for cemiplimab vs. 6% for chemotherapy.

The safety of cemiplimab was evaluated in 1,281 patients with advanced solid malignancies. The most common immune-mediated adverse reactions included hypothyroidism hyperthyroidism and pneumonitis.