, 2025-04-23 09:27:00
The National Institute for Health and Care Excellence (NICE) has recommended nivolumab (Opdivo) plus ipilimumab (Yervoy) for some people in England with advanced colorectal cancer.
The treatment is recommended for adults with untreated, unresectable, or metastatic colorectal cancer that shows high microsatellite instability (MSI-H) or mismatch repair deficiency (dMMR).
In final draft guidance, NICE reversed its earlier decision not to recommend the combination therapy. The change followed additional clinical data from manufacturer, Bristol-Myers Squibb, and UK approval by the Medicines and Healthcare products Regulatory Agency.
Targeting a Hard-to-Treat Subtype
MSI-H and dMMR are biomarkers associated with aggressive forms of colorectal cancer and poorer outcomes.
Around 4%-5% of patients with metastatic colorectal cancer present with these biomarkers.
Trial Supports Benefit
The efficacy and safety of the dual immunotherapy were studied in the CheckMate 8HW trial. This phase 3, randomised, open-label, international study enrolled 128 immunotherapy-naive adults at 128 centres in 23 countries.
Participants had unresectable or metastatic colorectal cancer and MSI-H or dMMR confirmed through local testing.
They were randomly assigned to receive either nivolumab plus ipilimumab, nivolumab alone, or chemotherapy with or without targeted therapies.
Improved Survival Outcomes
NICE said the combination therapy extended both progression-free survival and overall survival compared with chemotherapy.
Indirect comparisons also suggested it outperformed pembrolizumab in both measures.
Currently, standard care for this cancer subtype is either chemotherapy or pembrolizumab.
There are around 44,000 new cases of colorectal cancer diagnosed each year in the UK, with around 17,000 deaths.
NICE estimated that just over 700 people with untreated metastatic colorectal cancer with MSI-H or dMMR would be eligible to receive the newly approved treatment.
Routine NHS use in England is subject to a commercial arrangement with the manufacturer.
Dr Rob Hicks is a retired NHS doctor. A well-known TV and radio broadcaster, he has written three books and has regularly contributed to national newspapers, magazines, and online. He is based in the UK.
