Nivolumab in combination with ipilimumab has been granted an indication extension in the UK by the MHRA and is now recommended by the National Institute for Health and Care Excellence (NICE) for use on the NHS in England, Wales, and Northern Ireland 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).

This indication extension of the nivolumab-ipilimumab combination was pursued through the International Recognition Procedure (IRP), based on data from the Phase 3 CheckMate 8HW trial.

In this trial, progression-free survival (PFS) at 24 months was 72% with nivolumab-ipilimumab versus 14% with chemotherapy in the first line setting.

In the Final Draft Guidance (FDG), NICE has recommended the dual immunotherapy as a treatment option for eligible patients in England, Wales, and Northern Ireland.

The NICE recommendation follows a Medicines and Healthcare products Regulatory Agency (MHRA) indication extension of nivolumab-ipilimumab on 4 April 2025.

Eligible unresectable or metastatic colorectal cancer patients in England, Wales, and Northern Ireland will have access to this nivolumab-ipilimumab combination as a treatment option, via routine commissioning funded by the National Health Service (NHS).

Nivolumab-ipilimumab is the first dual checkpoint inhibitor treatment recommended in the UK for the first line treatment of MSI-H/dMMR mCRC.

Dr. Kai-Keen Shiu, Consultant Medical Oncologist at University College London Hospitals NHS Foundation Trust said: “NICE’s positive recommendation of nivolumab in combination with ipilimumab marks a major advancement for patients living with MSI-H/dMMR metastatic colorectal cancer. This dual immunotherapy regimen offers a meaningful alternative to existing treatments and improved quality of life for these patients versus chemotherapy. As an oncologist and researcher, I’m encouraged by the increasing and rapid access to innovative therapies which harness the immune system, providing new hope for patients with significant unmet medical need, their families, and caregivers.”

Professor Jenny Seligmann, Consultant Medical Oncologist and Senior Lecturer at the University of Leeds said: “Patients with mismatch repair deficient or microsatellite instability-high unresectable or metastatic colorectal cancer have historically had some of the worst outcomes of any colorectal cancer patients. The successful use of immunotherapy in these patients demonstrates how research can deliver targeted cancer treatments that lead to significant gains in outcomes. It is great news for patients and their families that NICE has recommended this treatment for use on the NHS.”

Colorectal cancer – also known as bowel cancer - is the fourth most common cancer in the UK, with approximately 44,000 people being diagnosed with the disease every year. Approximately 4-7% of mCRC patients have dMMR or MSI-H tumours.

These patients are less likely to benefit from conventional chemotherapy and typically have a poor prognosis.

Bowel cancer can affect someone at any age, but it is most prevalent in people over the age of 50 (94%).

More than 2,600 new cases are diagnosed in people under the age of 50 every year, with around 1 in 17 men and 1 in 20 women being diagnosed during their lifetime.The disease is treatable and curable if diagnosed early.

Guy Oliver, UK and Ireland General Manager of a global biopharmaceutical company said: “We know that cancer patients benefit from access to innovative treatments, and this is a significant milestone for eligible unresectable or metastatic colorectal cancer patients in England, Wales, and Northern Ireland. This dual immunotherapy is another example of our commitment to expanding treatment options for patients and addressing unmet medical needs.”

The MHRA and NICE decisions are supported by data from the Phase 3 CheckMate 8HW trial.

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).

 At 24 months, PFS was 72% for the nivolumab-ipilimumab combination, compared with 14% for the investigator’s choice of chemotherapy.

The safety profile for this dual immunotherapy combination remained consistent with previously reported data and was manageable with established protocols, with no new safety signals identified. 

Source: Bristol Myers Squibb