NICE gives green light for MSD’s Keytruda

The decision is the first verdict based on data from a wider immunotherapy ‘basket’ study

MSD has revealed that the National Institute for Health and Care Excellence (NICE) has recommended the use of Keytruda.

Also known as pembrolizumab, the therapy treats tumours with microsatellite instability-high (MSI-H) or mismatch repair deficiency (dMMR). It also involves adults with advanced or recurrent endometrial cancer that has progressed during or after platinum-based therapy, as well as certain patients with gastric, small intestine or biliary cancer.

The decision from NICE is the first verdict based on data from a wider immunotherapy basket study. In contrast to a traditional clinical trial, a basket version tests treatments on multiple types of cancer, with the same specific molecular alteration. Using this method can decrease the number of studies required to help bring treatments to patients.

Last year, a UK licence was issued for the indication of pembrolizumab among patients as a monotherapy across five MSI-H/dMMR tumour sites, meeting specific criteria across the basket trial. This included its indication for treating metastatic or unresectable MSI-H/dMMR colorectal cancer following fluoropyrimidine-based combination therapy.

In MSI-H/dMMR unresectable or metastatic gastric, small intestine, or biliary cancer, pembrolizumab was licensed for candidates with disease progression on or following at least one prior therapy.

Julie Harrington, CEO at Guts UK, explained: “We are delighted that some people with metastatic gastric, small intestine, biliary and colorectal cancer have gained access to an additional treatment option.

“As the first immunotherapy multi-tumour basket trial recommended by NICE for people with these types of tumours, this decision will help address this unmet need.”

David Long, Head of Oncology at MSD UK, welcomed the approval from NICE for the basket study for adults with previously treated MSI-H/dMMR tumours, saying: “MSI-H/dMMR tumours are associated with a poorer prognosis in advanced cancers, compared with non-MSI-H/dMMR status, which means there is a high unmet for patients with these gene features.”

Helen Morement, CEO at AMMF, also welcomed the approval for patients and clinical communities, adding: “More effective treatments are desperately needed to treat cholangiocarcinoma. This treatment option offers a small but important step forward in the treatment of some people with cholangiocarcinoma for whom, to this point, there has been so very little.”