Dual immunotherapy for the first line treatment of adult patients with mismatch repair deficient or microsatellite instability-high unresectable or metastatic colorectal cancer now available in Scotland
Medical Media , Trade Media , Consumer Media
19/01/26
Opdivo® (nivolumab) in combination with Yervoy® (ipilimumab) has been made available within NHS Scotland for the first line treatment of adult patients with mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) unresectable or metastatic colorectal cancer (mCRC).1
The Scottish Medicines Consortium (SMC) acceptance follows a National Institute for Health and Care Excellence (NICE) recommendation of the nivolumab-ipilimumab combination in England, Wales, and Northern Ireland in 2025.2 The acceptance provides an additional treatment option for eligible patients in Scotland with MSI-H/dMMR mCRC.1
The SMC decision is supported by data from the Phase 3 CheckMate 8HW trial.1,3 In this trial, progression-free survival (PFS) at 24 months was 72% with nivolumab-ipilimumab versus 14% with chemotherapy in the first line setting.4
(Uxbridge, Middlesex, Monday 19 January 2026) – Bristol Myers Squibb (BMS) has announced that the Scottish Medicines Consortium (SMC) has accepted Opdivo® (nivolumab) in combination with Yervoy® (ipilimumab) for the first line treatment of adult patients with mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) unresectable or metastatic colorectal cancer (mCRC).1
Eligible unresectable or metastatic colorectal cancer patients in Scotland will have access to the nivolumab-ipilimumab combination as a treatment option, via routine commissioning funded by NHS Scotland.1 Nivolumab-ipilimumab is the first dual checkpoint inhibitor treatment accepted in Scotland for the first line treatment of MSI-H/dMMR mCRC.
Colorectal cancer – also known as bowel cancer - is one of the most common cancers in Scotland, with approximately 4,000 people being diagnosed with the disease every year.5 Approximately 4-7% of mCRC patients have dMMR or MSI-H tumours.4 These patients are less likely to benefit from conventional chemotherapy and typically have a poor prognosis.4 Bowel cancer can affect someone at any age, but it is most prevalent in men and people over the age of 50 (94%).5,6 The disease is treatable and curable, if diagnosed early.6 In Scotland, the number of people with bowel cancer is estimated to increase by 44% from 2019 to 2044 (from 29,000 prevalent cases to 41,700).7 Cases of early-onset bowel cancer are increasing in younger adults globally and in the UK.8
Professor Richard Wilson, Consultant in Medical Oncology at the Beatson West of Scotland Cancer Centre and Professor of Gastro-Intestinal Oncology at the University of Glasgow said: “I welcome this positive SMC decision for Scottish colorectal cancer patients and their families. We can now offer the nivolumab and ipilimumab immunotherapy earlier for those with DNA mismatch repair deficient unresectable or metastatic colorectal cancer, which has been shown to result in prolonged progression free survival with improved quality of life compared to the chemotherapy-based treatments we have previously used. It also demonstrates the importance of scientific research that delivers targeted treatments which can lead to genuine benefits for people living with cancer.”
Professor Janet Graham, Consultant Medical Oncologist at the Beatson West of Scotland Cancer Centre and Honorary Professor at the University of Glasgow School of Cancer Sciences said: “The SMC recommendation is a positive step forward for patients in Scotland with dMMR or MSI-H unresectable or metastatic colorectal cancer. Having an innovative combination immunotherapy available as a first-line treatment option offers a meaningful alternative to existing approaches. Importantly, the nivolumab-ipilimumab combination is generally well tolerated, which may help to support patients’ quality of life during a crucial time.”
Guy Oliver, UK and Ireland General Manager at Bristol Myers Squibb said: “This is a significant milestone for eligible unresectable or metastatic colorectal cancer patients in Scotland – a country with a higher rate of bowel cancer compared to many others in the Western world. While a person’s risk of developing the disease is higher from the age of 50 onwards, we are seeing rates increase in younger adults, making early diagnosis and access to innovative treatments such as dual immunotherapies crucially important in helping to address unmet medical needs.”
The SMC decision follows a Medicines and Healthcare products Regulatory Agency (MHRA) indication extension of nivolumab-ipilimumab in 2025.9,10 This was supported by data from the Phase 3 CheckMate 8HW trial.1,3 In the study, nivolumab-ipilimumab demonstrated a statistically significant and clinically meaningful improvement in the co-primary endpoint of progression-free survival (PFS) as assessed by Blinded Independent Central Review (BICR).4 At 24 months, PFS was 72% for the nivolumab-ipilimumab combination, compared with 14% for the investigator’s choice of chemotherapy.4 The safety profile for this dual immunotherapy combination remained consistent with previously reported data and was manageable with established protocols, with no new safety concerns identified.4
Notes to editors
About Nivolumab
Nivolumab attaches to a target protein called programmed death-1 receptor (PD-1) that can switch off the activity of T cells (a type of white blood cell that forms part of the immune system, the body’s natural defences). By attaching to PD-1, nivolumab blocks its action and prevents it from switching off T cells. This helps increase their activity against cancer cells.11 More information can be found in the Summary of Product Characteristics.9
About Ipilimumab
Ipilimumab helps the immune system to attack and destroy cancer cells.12 It is used in combination with nivolumab to treat various cancers.10 More information can be found in the Summary of Product Characteristics.10
About the Phase 3 CheckMate 8HW trial
CheckMate 8HW (NCT04008030) is a Phase 3 randomised, open-label trial evaluating nivolumab plus ipilimumab compared to nivolumab alone or the investigator’s choice of chemotherapy (mFOLFOX-6 or FOLFIRI with or without bevacizumab or cetuximab) in adult patients with MSI-H or dMMR mCRC.3,4
303 patients were randomised to receive either nivolumab plus ipilimumab (nivolumab 240 mg plus ipilimumab 1 mg/kg Q3W every 3 weeks for the first 12 weeks, followed by nivolumab 480 mg Q4W for up to 2 years), or investigator’s choice of chemotherapy.4 The co-primary endpoint considered by MHRA and NICE for this indication was PFS per BICR for nivolumab plus ipilimumab compared to investigator’s choice of chemotherapy in the first line setting.3,4 The trial also evaluates several secondary efficacy endpoints, including overall survival, which is ongoing, as well as safety.3,4
About dMMR or MSI-H colorectal cancer
CRC is cancer that develops in the colon or the rectum, which are parts of the body’s digestive or gastrointestinal system.13 dMMR occurs when the genes that repair mismatch errors in DNA replication are missing or non-functional, leading to MSI-H tumours.14,15,16
About Bristol Myers Squibb: Transforming Patients’ Lives Through Science
At Bristol Myers Squibb, our mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. We are pursuing bold science to define what’s possible for the future of medicine and the patients we serve. For more information, visit us at bms.com/gb and follow us on LinkedIn.
References:
1. Scottish Medicines Consortium. Nivolumab (Opdivo) Final Advice Document. December 2025. https://scottishmedicines.org.uk/media/9660/nivolumab-opdivo-final-dec-2025-for-website.pdf. Accessed January 2026.
2. National Institute for Health and Care Excellence. Final Draft Guidance. https://www.nice.org.uk/guidance/gid-ta10165/documents/674. Accessed: January 2026.
3. Clinicaltrials.gov. A Study of Nivolumab, Nivolumab Plus Ipilimumab, or Investigator's Choice Chemotherapy for the Treatment of Participants With Deficient Mismatch Repair (dMMR)/Microsatellite Instability High (MSI-H) Metastatic Colorectal Cancer (mCRC) (CheckMate 8HW). Available at: https://www.clinicaltrials.gov/study/NCT04008030. Accessed January 2026.
4. Andre T, Elez E, Van Cutsem E, et al. Nivolumab plus Ipilimumab in Microsatellite-Instability–High Metastatic Colorectal Cancer. N Engl J Med. 2024;391:2014-2026.
5. Public Health Scotland. Bowel Screening. Available at: https://publichealthscotland.scot/population-health/conditions-and-diseases/disease-screening/bowel-screening/overview/facts-about-bowel-cancer/. Accessed January 2026.
6. Bowel Cancer UK. Bowel Cancer. Available at: www.bowelcanceruk.org.uk/about-bowel-cancer/bowel-cancer/. Accessed January 2026.
7. Public Health Scotland. Scottish Burden of Disease. Main Points. Available at: https://www.scotpho.org.uk/media/2673/2025-06-24-scottishburdenofdisease-colorectalcancer.pdf. Accessed January 2026.
8. Cancer Research UK. Cancer News. Available at: https://news.cancerresearchuk.org/2024/12/11/early-onset-bowel-cancer-rise-global-phenomenon/. Accessed January 2026.
9. EMC. Opdivo (nivolumab). Summary of Product Characteristics (SmPC). Available at: https://www.medicines.org.uk/emc/product/6888/smpc. Accessed January 2026.
10. EMC. Yervoy (ipilimumab). Summary of Product Characteristics (SmPC). Available at: https://www.medicines.org.uk/emc/product/4683/smpc. Accessed January 2026.
11. EMC. Opdivo (nivolumab). Patient Leaflet (PIL). https://www.medicines.org.uk/emc/files/pil.6888.pdf. Accessed January 2026.
12. EMC. Yervoy (ipilimumab). Patient Leaflet (PIL). Available at: https://www.medicines.org.uk/emc/files/pil.4683.pdf. Accessed January 2026.
13. National Cancer Institute. NCI Dictionary of Cancer Terms: colorectal cancer. Available at https://www.cancer.gov/publications/dictionaries/cancer-terms/def/colorectal-cancer. Accessed January 2026.
14. National Cancer Institute. NCI Dictionary of Cancer Terms: dMMR. Available at https://www.cancer.gov/publications/dictionaries/cancer-terms/def/dmmr. Accessed January 2026.
15. National Cancer Institute. NCI Dictionary of Cancer Terms: MSI-H cancer. Available at https://www.cancer.gov/publications/dictionaries/cancer-terms/def/msi-h-cancer. Accessed January 2026.
16. Guan J, Li GM. DNA mismatch repair in cancer immunotherapy. NAR Cancer. 2023;5(3):zcad031. Published 2023 Jun 13. doi:10.1093/narcan/zcad031.
7356-GB-2600012
January 2026