NICE says Libtayo can be used for advanced cervical cancer

Around 90 women with advanced cervical cancer in the UK could be eligible for treatment with Regeneron's immunotherapy Libtayo each year, after the drug was recommended for use by the NHS in England and Wales.

In final draft guidance, reimbursement authority NICE has given a green light to the PD-1 inhibitor for the treatment of recurrent or metastatic cervical cancer that has progressed on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 (cemiplimab) if they have not had prior immunotherapy, and can receive up to 16 six-week treatment cycles with the drug. At the moment, the only treatment option available to women in this category is single-agent chemotherapy.

The new guidance brings England into line with Scotland, which recommended Libtayo for the same indication in early 2025, with Wales and Northern Ireland likely to follow suit following NICE's endorsement.

Despite the 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 from a paper published in The Lancet – cervical cancer remains the 14th most common cancer affecting women in the UK, with around 3,300 new cases each year. It is thought HPV, which is spread through close skin-to-skin contact, is responsible for 99% of cases.

"Recurrent or metastatic cervical cancer has a substantial impact on length and quality of life," said NICE in a statement on 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."

Evidence for that comes from the EMPOWER Cervical-1, which revealed a median overall survival of 11.7 months in the Libtayo arm, compared to 8.5 months with chemo, over nearly four years of follow-up. At the two-year timepoint, around 28% of Libtayo-treated women were still alive, versus less than 12% of the chemo arm.

Libtayo is already used 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 a late entrant into the PD-1/PD-L1 inhibitor category, the drug has started enjoying a surge in sales over the last year after getting approval for adjuvant use in CSCC, a niche free of competition from other drugs in the class.