A healthy T cell. Image via Wikimedia Commons
Melanoma patients in England and Wales are to become the first in Europe to benefit from a powerful combination of immunotherapy drugs.
The National Institute for Health and Care Excellence (NICE) has approved the combination therapy of nivolumab (Opdivo) and ipilimumab (Yervoy) for people with melanoma that has spread around the body.
Used in isolation, only a minority of patients respond to these drugs, whereas in combination they appear to work in around six out of 10 patients.
Around 12,200 people are diagnosed with the disease each year. And some 1,300 people could be eligible for the combination every year, in one of the fastest drug appraisals carried out by the NHS watchdog.
NICE approved the drugs within weeks of them receiving their licence from the European Medicines Agency.
Professor Peter Johnson, Cancer Research UK’s chief clinician, said the speedy decision matched the ‘real progress’ that patients are seeing with immunotherapies in clinical trials.
Johnson added that ongoing research will need to focus on working out how best to use these combinations of drugs in more patients.
“These results give new hope to melanoma patients. But, it’s important to remember that more powerful treatment comes with an increased chance of severe side effects,” he said.
“Our research now needs to identify which patients are most likely to benefit from this combination and who is most likely to experience the side effects, so doctors can make sure we get the balance right.”
Professor Carole Longson, director of the health technology evaluation centre at NICE, said: “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.
“The evidence we examined was very promising and I know further trials are ongoing which have also released encouraging data.”
In April, the results of a phase II clinical trial of the drugs showed impressive results.
Of 95 patients given the combined treatment, more than 60% were still alive after two years.
Dr James Larkin, consultant medical oncologist at the Royal Marsden Hospital in London, has treated patients with the drugs as part of another on-going trial.
He said the immunotherapy drugs – which enable the body’s immune system to fight tumours – are “an effective two-pronged attack against the cancer”.
The drugs, known as ‘checkpoint inhibitors’, target two different molecules on immune cells, effectively lifting the ‘brakes’ on the immune system so it can attack the tumour cells.
Ipilimumab targets a molecule on immune cells called CTLA-4 while nivolumab targets another called PD-1.
The drugs have also shown promise in other cancers, including advanced lung cancer.
Research presented at the American Society of Clinical Oncology (ASCO) conference last week showed that the combination treatment doubled the number of patients who saw their tumours stop growing.