New NHS Drug Option for Advanced Endometrial Cancer
The final draft guidance allows pembrolizumab (Keytruda, Merck Sharp & Dohme) to be used alongside carboplatin and paclitaxel within its marketing authorisation on the NHS. It applies to adults with previously untreated primary advanced or recurrent endometrial cancer.
Treatment should stop after 2 years, or earlier if there is disease progression or unacceptable toxicity, NICE said.
First-Line Immunotherapy
This is the first time immunotherapy has been combined with chemotherapy as a first-line treatment for this type of cancer. Around 2100 people in England could benefit, the regulator said.
The approval overturns NICE's earlier rejection in March, when it found insufficient evidence that the drug combination offered value for money. At the time, it recommended against its use in adults with previously untreated primary, advanced, or recurrent disease.
Endometrial cancer is the most common gynaecological cancer in the UK, with almost 10,000 people diagnosed each year. Only 15% of people diagnosed with stage 4 endometrial cancer survive for 5 years or more.
People with untreated primary advanced or recurrent endometrial cancer usually have platinum-based chemotherapy, such as the combination carboplatin and paclitaxel.
Trial Evidence Showed Reduced Mortality Risk
NICE's updated decision was based on evidence from the KEYNOTE-868 study, an ongoing multicentre, randomised, double-blind, phase 3 trial. It is comparing the combination of pembrolizumab with chemotherapy, followed by pembrolizumab maintenance, against chemotherapy alone followed by placebo.
NICE said that adding pembrolizumab to chemotherapy reduced the risk of death by 26% compared with chemotherapy alone. Trial data also suggest the treatment slows disease progression, although the effect on overall survival remains uncertain as the trial continues.
'Powerful' New Treatment Option
Pembrolizumab is a monoclonal antibody that acts as an immune checkpoint inhibitor. It is administered intravenously and blocks the PD-1 protein on the surface of T cells, allowing them to identify and attack cancer cells.
'For people with advanced endometrial cancer, this innovative combination offers a powerful new treatment option,' said Helen Knight, director of medicines evaluation at NICE. 'It marks a major step forward,' she added.
The treatment will be available immediately through England's Cancer Drugs Fund, following a commercial deal that provides the NHS with a discount.
Helen Hyndman, the Eve Appeal's Ask Eve lead nurse, told Medscape News UK that NICE's recommendation was 'great news' and would 'offer hope, a better quality of life, and improve outcomes for those affected'.
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