3 July 2015
A cancer drug that aids the immune system in tackling tumours, nivolumab, has been given the green light in the UK.
Immunotherapy treatments work by harnessing the body’s own immune system to tackle cancer, rather than targeting the tumour directly. Nivolumab works by blocking a crucial protein called programmed cell death protein 1 or PD-1. Effectively it stops a pathway that cancer cells normally use to avoid being recognised and destroyed by immune system cells.
Nivolumab (Opdivo) was a headline topic at the world’s biggest annual cancer conference last month, where results from two trials were reported. The conference reportedly heralded a major step forward for immunotherapy treatments and in particular PD-1 inhibitors and combination therapies.
Bristol-Myers Squibb’s nivolumab is the first PD-1 inhibitor to be approved in Europe. The treatment has been approved for the treatment of lung cancer through the UK’s Early Access to Medicines Scheme (EAMS), along with being given an EU licence for melanoma. However, it is not yet available on the NHS as it is awaiting approval from the Cancer Drugs Fund, a dedicated and sometimes controversial government fund to pay for life-extending treatments that are not cost-effective enough to be offered via normal mechanisms.
One recent trial of nivolumab in advanced lung cancer demonstrated that patients receiving the immunotherapy treatment survived several months longer than those on chemotherapy, and experienced fewer side effects.
In a separate trial nivolumab was used in combination with the already approved drug ipilimumab, to treat patients with advanced melanoma. The trial involved 945 people who were either given these drugs alone or in combination. Over half of the patients receiving the combined treatment (58 per cent) responded to the treatment and their melanoma stopped advancing for nearly a year. In contrast only a fifth (19 per cent) of those given just illimumab responded to the treatment. However, people whose tumour displayed the protein that nivolumab targets did just as well with nivolumab alone as in combination. Also, there were more side effects with the combination therapy.
Gill Nuttall, from Melanoma UK, said: “There has been an alarming rise in the number of cases of melanoma in the UK over recent years…Today’s news is therefore very welcome as it provides more options for patients and the potential of better, longer survival”.
Looking ahead, the researchers next have to tackle the side effects of combination therapy and understand which patients will benefit the most and from which combination of drugs.
An alternative melanoma immunotherapy drug Keytruda (pembrolizumab) has also been available on the EAMS since March and beat nivolumab to approval in the US.
Nivolumab’s approval gives another option for cancer patients but there is still a lot more to learn in the field of immunotherapy, according to Prof Karol Sikora or Buckingham’s medical school. Cost, especially with combination th erapies, remains a barrier, with combined treatment estimated to cost more than £130,000.