The National Institute for Health and Care Excellence (NICE) has recommended the use of the immunotherapy drug nivolumab (Opdivo) for some people in England with oesophageal cancer – a cancer that forms in the tube that connects the mouth to the stomach.
Patient and clinical experts describe this decision as a ‘step change’ for people with this cancer, as there are currently no treatments available following chemotherapy, radiotherapy and surgery.
Clinical trial evidence shows that for people who had some cancer left behind after chemoradiotherapy and surgery, nivolumab increases the time people live without their cancer returning by around a year compared to current standard care, which is surveillance alone.
Nivolumab is also likely to be more effective at extending how long people live, but clinical trial evidence is not yet available.
Ben Chiu, policy manager at Cancer Research UK, said that this is “good news” for people affected by this type of cancer.
“This group of patients currently has no treatments available after chemotherapy, radiotherapy and surgery. Clinical trials have shown that nivolumab can increase the time they live without their cancer returning,” he added.
A need for additional treatments
Oesophageal cancer is usually treated with a mix of chemotherapy and radiotherapy followed by surgery. However, around 50 to60% of people who still have a bit of their cancer left behind after chemoradiotherapy will see their disease come back.
A patient expert explained that people have ongoing fear because of a lack of available active treatments after surgery, which affects their mental wellbeing and quality of life, so new treatments like nivolumab are sorely needed.
Nivolumab is a type of immunotherapy that aims to boost the immune system’s ability to recognise and kill cancer cells. It works by blocking a molecule found on immune cells – called PD-1 – from talking to cancer cells.
The drug was recently approved for a type of advanced oesophageal cancer by NICE in June and the Scottish Medicines Consortium (SMC) in August, as well as for the treatment for a type of advanced bowel cancer in combination with another drug called ipilimumab (Yervoy).
Delaying cancer’s return
The clinical evidence for the effectiveness of this treatment came from a late-stage trial that compared nivolumab with a placebo. The trial included 794 patients from 29 countries who were randomly assigned to receive nivolumab (532 people) or a placebo (262 people).
The trial showed that nivolumab increased the time people lived without their cancer returning, with an average of 22.4 months for those who received nivolumab compared to 10.4 months with placebo.
Nivolumab is also expected to extend how long people live overall, with a clinical expert noting that those treated with nivolumab are more likely to never have their disease come back, but the final data for this is not yet available.
The patients on the trial had 1 of 2 types of oesophageal cancer – oesophageal squamous cell carcinoma or oesophageal adenocarcinoma. The results show that nivolumab may be more effective for people who have squamous cell carcinoma, but it is beneficial for both.
Overall, the treatment was considered cost-effective for use in the NHS by NICE and will now be an option on the NHS in England. NICE decisions are usually adopted in Wales and Northern Ireland as well, so the decision is likely to affect patients in all 3 nations. Scotland has a separate process for reviewing drugs.