An immunotherapy drug will be made available to some patients with advanced melanoma skin cancer on the NHS in England.
Nivolumab (Opdivo) will be an option for patients whose melanoma has spread to the lymph nodes or other organs and who have already had surgery, according to a recommendation from the National Institute for Health and Care Excellence (NICE). The drug works by boosting the immune system’s ability to kill cancer cells and will be given to help target any cancer cells left behind after surgery.
The current standard of care for these patients after surgery is monitoring to see if the cancer comes back.
In a clinical trial involving 906 patients, nivolumab was compared to another immunotherapy drug, ipilumumab (Yervoy). Both treatments have been tested in patients with melanoma that has spread to other parts of the body, but neither had previously been used to treat patients after surgery.
7 in 10 patients taking nivolumab were cancer free 12 months after treatment, compared to 6 in 10 of those taking ipilimumab. Patients taking nivolumab were cancer free for 30.8 months on average, compared with 24.1 months in those taking ipilimumab, according to unpublished data presented at a conference.
Severe side effects, including rashes, diarrhoea and raised liver enzymes, were also less common in those taking nivolumab. 3 in 20 patients taking nivolumab experienced severe side effects compared with 9 in 20 patients taking ipilimumab.
Long term data needed
While the clinical trial results looked promising, the long-term effects of using the drug in this way aren’t known, and the trial is still running.
NICE said that there are no trials directly comparing nivolumab with the routine surveillance, the standard of care. But the committee noted that nivolumab is likely to have benefits compared to this option given the results of trials that have looked at the treatments separately.
The committee also said there was limited information on the overall survival benefits of the nivolumab.
Nivolumab will therefore be made available through the Cancer Drugs Fund while more data is collected on its effectiveness. The Fund was redesigned in 2016 to speed up access to promising new treatments.
The drug was given an initial ‘no’ for use on the NHS in England in August.
Expanding treatment options
Last week a different immunotherapy drug, pembrolizumab (Keytruda), was added to the Cancer Drugs Fund for people whose melanoma has spread to the lymph nodes and who have already had surgery.
Rose Gray, policy manager at Cancer Research UK, said that the decision gives people with melanoma another option to reduce the risk of their cancer coming back (relapse).
“Together, these decisions are great news for patients, who previously would have had to watch and wait for any signs of relapse,” she said. “They also show the value of the Cancer Drugs Fund as a way to make promising new treatments available to patients quickly, while more evidence is collected about their effectiveness.”
NICE (2018) Nivolumab for adjuvant treatment of resected stage III and IV melanoma [ID1316] – Final appraisal document