The immunotherapy combination nivolumab/ipilimumab has been recommended for patients with advanced malignant melanoma, according to draft guidance from the National Institute for Health and Care Excellence (NICE).
The approval means that patients in England and Wales will be the first in Europe to receive the drug combination, following marketing approval by the European Commission in May 2016.
“After one of the fastest drug appraisals NICE has carried out, these promising new immunotherapy treatments for advanced melanoma look set to significantly extend the life of people with the condition,” says 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.”
In a phase III trial, involving around 600 patients with both BRAF positive and negative tumours, combination treatment resulted in progression-free survival of 11.5 months compared with 2.9 months with ipilimumab alone.
Data from a phase II trial showed that overall survival at 18 months was 69% among patients who received the combination, compared with 35% in historical data on patients who received ipilimumab monotherapy.
However, given the increased rate of side effects, which include fatigue, diarrhoea, nausea and liver damage, NICE caution that the drug combination should only be given to patients who are fit enough to tolerate them. It is thought the new treatment option will be available to around 700–1,300 patients a year.
Both drugs have also previously been approved individually by NICE for advanced malignant melanoma. But ipilimumab has fallen from favour as a first-line monotherapy because of the superior efficacy and lower toxicity of nivolumab and pembrolizumab – another immunotherapy recently approved by NICE.
Both nivolumab and ipilimumab are marketed by Bristol-Myers Squibb and the combination’s approval is contingent on a discount agreed between the manufacturer and the Department of Health.