Sandbox
Around 90 women with advanced cervical cancer in the UK could soon be eligible for treatment with Regeneron's immunotherapy Libtayo (cemiplimab) each year, after the drug was officially recommended for use by the NHS in England and Wales.
In its final draft guidance, the reimbursement authority NICE gave a green light to the PD-1 inhibitor for the treatment of recurrent or metastatic cervical cancer that has progressed on or after platinum-based chemotherapy. Patients are eligible for Libtayo if they have not had prior immunotherapy, and they can receive up to 16 six-week treatment cycles. Currently, the only treatment option available to women in this category is single-agent chemotherapy.
Aligning with Scotland
This new guidance brings England into line with Scotland, which recommended Libtayo for the same indication in early 2025. Wales and Northern Ireland are likely to follow suit following NICE's endorsement.
Despite the substantial impact of the HPV vaccination campaign in the UK-which has resulted in zero young women dying of cervical cancer between 2020 and 2024, according to data published in The Lancet-cervical cancer remains the 14th most common cancer affecting women in the UK. There are approximately 3,300 new cases each year, with HPV thought to be responsible for 99% of cases.
A Meaningful Improvement in Survival
"Recurrent or metastatic cervical cancer has a substantial impact on length and quality of life," NICE noted in a statement regarding the decision. "Living with the condition is physically and emotionally exhausting, and when the cancer recurs or spreads again, treatment options become increasingly limited."
The agency added, "Our independent committee concluded that it offers a meaningful improvement in prolonging the time before the disease gets worse and in overall survival compared with standard chemotherapy."
Clinical evidence supporting this decision stems from the EMPOWER Cervical-1 trial. Over a follow-up period of nearly four years, the trial revealed a median overall survival of 11.7 months in the Libtayo arm, compared to 8.5 months with chemotherapy. At the two-year mark, approximately 28% of Libtayo-treated women were still alive, compared to less than 12% in the chemotherapy arm.
Expanding Libtayo's Footprint
Libtayo is already utilized by the NHS in England for two forms of skin cancer-cutaneous squamous cell carcinoma (CSCC) and basal cell carcinoma (BCC)-in patients who have relapsed after prior treatment. While considered a late entrant into the highly competitive PD-1/PD-L1 inhibitor category, the drug has enjoyed a surge in sales over the past year following approval for adjuvant use in CSCC, a niche largely free of competition from other drugs in the class.
