Bristol Myers Squibb (BMS) has announced that the National Institute for Health and Care Excellence (NICE) has issued a Final Appraisal Document (FAD) recommending the combination of nivolumab plus ipilimumab for advanced colorectal (bowel) cancer patients with the rare MSI-H/dMMR mutation, after they have previously failed fluoropyrimidine-based chemotherapy.

This is the first immunotherapy combination approved in the UK for this patient group, who have a form of advanced bowel cancer characterised by rare gene mutations known as high microsatellite instability (MSI-H) or mismatch repair deficiency (dMMR), which affect how the cancer grows.

“Advanced bowel cancer with the rare MSI-H/dMMR mutation can be difficult to treat,” said Genevieve Edwards, Chief Executive at Bowel Cancer UK. “If chemotherapy fails then this patient population has had limited treatment options, so we welcome the NICE decision to make this combination of nivolumab with ipilimumab available to them.”

The NICE recommendation is based on data from the ongoing Phase II Checkmate-142 study, which showed that the combination of nivolumab plus ipilimumab can potentially offer long progression-free survival (PFS) and overall survival (OS).

An objective response rate of 65% after a follow up period of 51 months was seen with the combination treatment.

The decision from NICE offers a new treatment option for patients with bowel cancer after chemotherapy has failed, for whom there are currently limited treatment options.

“At Bristol Myers Squibb we are committed to bringing our innovative medicines to patients across the UK and Ireland,” said Dr Hubert Bland, Executive Medical Director UK and Ireland, Bristol Myers Squibb. “We are grateful to the hospitals and patients involved in the trials that have helped bring this immunotherapy combination to patients with advanced bowel cancer.”

Cancer which originates in the colon or rectum and has spread to other organs of the body is called advanced bowel cancer or metastatic colorectal cancer.

There are around 42,300 new cases of bowel cancer in the UK every year, of which over half are diagnosed at a late stage.

When bowel cancer is diagnosed at its latest stage, only 10% of people will survive for five years or more.

Approximately 4% of patients with metastatic colorectal cancer show high MSI, where errors that occur during DNA replication are not corrected by the body’s normal DNA repair system.

DNA MMR deficiency results in MSI mutations, tumour development and progression.

Source: Bristol Myers Squibb