NICE backs Keytruda for incurable cervical cancer via CDF

Hundreds of NHS patients with an incurable form of cervical cancer will be able to get treatment using a combination regimen based on Merck & Co/MSD’s cancer immunotherapy Keytruda, thanks to new guidance from NICE.

The cost-effectiveness agency has concluded that a combination of checkpoint inhibitor Keytruda (pembrolizumab) and chemotherapy – with or without the VEGF-targeting antibody bevacizumab – should be an option for treating persistent, recurrent, or metastatic cervical cancer in adult women whose tumours express PD-L1 with a combined positive score (CPS) of at least 1.

The regimen – which in trials was shown to extend the lives of patients by around eight months – will be made available via the Cancer Drugs Fund (CDF) for the time being, while additional information is gathered to see if it should become routinely available on the NHS.

NICE’s decision follows a positive recommendation for the therapy from the Scottish Medicines Consortium (SMC) last month, and brings England and Wales into alignment.

The guidance effectively layers in Keytruda on top of chemo with or without bevacizumab, the current standard treatment for women with advanced cervical cancer that has progressed despite prior treatment.

It is based on preliminary results from the phase 3 KEYNOTE-826 study, which found median progression-free survival (PFS) was improved with Keytruda, with a trend towards improved survival that NICE’s appraisal committee thinks is likely to become statistically significant once the data matures.

The study was the first to show that a checkpoint inhibitor was able to help patients with advanced cervical cancer live longer.

Under the final guidance, Keytruda’s use is limited to two years of uninterrupted treatment, or earlier if disease progresses, and the drug has to be provided at a confidential discount.

Dame Cally Palmer, NHS England’s national director for cancer, said: “Making this life-extending drug available today is a significant moment for women with advanced cervical cancer, which disproportionately affects younger women, allowing them to spend more precious time with loved ones and enjoy a better and longer quality of life.”

Cervical cancer is the 14th most common cancer among women in the UK, with around 3,200 diagnoses every year. Death rates have started to decline since the introduction of routine vaccination against human papillomavirus (HPV), which is a major cause of the disease.

The availability of Keytruda as a treatment for women whose options are running out was hailed as “fantastic news” by Samantha Dixon, chief executive of patient organisation Jo’s Cervical Cancer Trust.

“Treatments are far too limited for those living with advanced cervical cancer and this provides patients with a valuable option, hope and, most importantly, time,” she said. “Cervical cancer affects women of all ages, many are young. They have families, children, jobs, [and] caring responsibilities.”

The guidance is due to come into effect from 3rd May.