Cost regulators for the NHS in England and Wales are endorsing use of Bristol-Myers Squibb's immunotherapy combo Opdivo/Yervoy to treat patients with advanced melanoma.

The National Institute for Health and Care Excellence has published draft guidelines declaring the combination a cost-effective use of NHS resources, after concluding that its incremental cost-effectiveness ratio compared to MSD's Keytruda (pembrolizumab) is likely to be less than £30,000 per QALY gained when incorporating a patient access scheme agreed between the firm and the Department of Health.

The Opdivo (nivolumab)/Yervoy (ipilimumab) regimen was approved by European regulators just weeks ago on findings from the Phase III Checkmate-067 study, which showed a median progression-free survival of 11.5 months versus 6.9 months for Opdivo and 2.9 months for Yervoy.

Recently published data from the Phase II CheckMate-069 trial showed that the combination demonstrated a two-year overall survival rate of 69 percent compared to 53 percent for Yervoy alone in patients with BRAF wild-type advanced melanoma.

"These promising new immunotherapy treatments for advanced melanoma look set to significantly extend the life of people with the condition," noted Professor Carole Longson, director of the Health Technology Evaluation Centre at NICE.

"The evidence we examined was very promising and I know further trials are ongoing which have also released encouraging data."

The Institute says that around 1,300 people could be eligible for the drug combination each year, but also stressed that doctors will need to be careful that patents are fit enough and willing to tolerate its often significant side effects such as diarrhoea and liver damage.