Bristol Myers Squibb (BMS) has announced that its dual immunotherapy combination has been recommended by the National Institute for Health and Care Excellence (NICE) as a first-line treatment for a subset of colorectal cancer patients.
The health technology assessment agency has recommended in final draft guidance that Opdivo (nivolumab) plus Yervoy (ipilimumab) be used on the NHS in England, Wales and Northern Wales to treat adults with mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) unresectable or metastatic colorectal cancer.
Approximately 44,000 people in the UK are diagnosed with colorectal cancer, also known as bowel cancer, every year. Up to 7% of patients with metastatic disease have dMMR or MSI-H tumours and, as a result, are less likely to benefit from conventional chemotherapy and typically have a poor prognosis.
NICE’s decision, which comes after the Medicines and Healthcare products Regulatory Agency granted an indicated extension to the combination earlier this month, is supported by positive results from the phase 3 CheckMate 8HW trial.
In the study, progression-free survival at 24 months was 72% with Opdivo plus Yervoy compared to 14% with investigator’s choice of chemotherapy in the first-line setting. The safety profile of the combination was also found to be consistent with previously reported data, with no new safety signals identified.
Guy Oliver, UK and Ireland general manager at BMS, 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.”
Sharing a similar sentiment, Kai-Keen Shiu, consultant medical oncologist at University College London Hospitals NHS Foundation Trust said the recommendation “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,” Shiu added.
NICE’s decision comes just two weeks after the US Food and Drug Administration approved Opdivo plus Yervoy as a first-line treatment for adult and paediatric patients aged 12 years and older with unresectable or metastatic MSI-H or dMMR colorectal cancer.
The Opdivo/Yervoy combination was also recently approved by the FDA as a first-line treatment for adults with unresectable or advanced cases of hepatocellular carcinoma, the most common type of liver cancer.