MSD – known as Merck & Co in the US and Canada – has announced that its anti-PD-1 therapy Keytruda (pembrolizumab) has been recommended by the National Institute for Health and Care Excellence (NICE) to treat endometrial cancer.
The health technology assessment agency has issued final draft guidance recommending that the drug be used on the NHS in England and Wales, in combination with carboplatin and paclitaxel chemotherapy, for adults with previously untreated primary advanced or recurrent endometrial cancer.
This includes both patients with mismatch repair proficient (pMMR) tumours and mismatch repair deficient (dMMR) tumours.
More than 9,700 new cases of endometrial cancer are diagnosed every year in the UK. The disease is the most common type of womb cancer and, while survival is generally good when diagnosed early, five-year survival rates can be 50% or less when diagnosed at stage 3 or 4.
Administered as an intravenous infusion, Keytruda works by increasing the ability of the body’s immune system to help detect and fight tumour cells. It will be available immediately for this patient population through the Cancer Drugs Fund.
NICE’s recommendation comes shortly after the Scottish Medicines Consortium accepted Keytruda for primary advanced or recurrent endometrial carcinoma within NHS Scotland and was supported by positive results from the late-stage KEYNOTE-868 trial, in which the Keytruda regimen resulted in longer progression-free survival (PFS) compared to chemotherapy alone.
Among patients with dMMR tumours, media PFS in the Keytruda regimen arm was not reached at a median follow-up of 14.4 months, compared to 8.3 months in the chemotherapy only cohort. For those with pMMR tumours, median PFS was 13.1 months in the Keytruda plus chemotherapy group at a median follow-up of ten months, versus 8.7 months in the chemotherapy arm.
Benson Fayehun, head of oncology at MSD in the UK, said: “With over 9,700 cases of endometrial cancer being diagnosed across the UK annually, the decision is a significant milestone for endometrial cancer patients. In particular, for those with pMMR tumours who have previously been a particularly underserved population.”
Also welcoming the recommendation, Eleanor Jones, chair of trustees at Peaches Womb Cancer Trust, said: “This additional treatment for primary advanced or recurrent pMMR and dMMR endometrial cancer will provide much needed options for patients currently facing the reality of limited cancer treatments.”