The Scottish Medicines Consortium (SMC) has approved the immunotherapy drug nivolumab (Opdivo) for patients with a type of advanced oesophageal cancer – cancer that forms in the tube that connects the mouth to the stomach – who have previously received chemotherapy.
Nivolumab is the first targeted immunotherapy treatment for people with this type of oesophageal cancer. It also causes fewer side effects than chemotherapy.
David Ferguson, public affairs manager for Cancer Research UK in Scotland, said: “We’re delighted that nivolumab has been approved to treat metastatic oesophageal cancer in Scotland. Cancer Research UK has previously funded clinical trials for this drug and it is a huge step forward for patients and their families.
“We hope that this approval will give patients facing this advanced form of cancer better options for treatment, as well as the chance for more precious time with loved ones.”
The news follows the approval of nivolumab for the same cancer type by the National Institute for Health and Care Excellence (NICE) in England in June, as well as for the treatment for a type of advanced bowel cancer in combination with the drug ipilimumab (Yervoy).
A needed treatment for an aggressive cancer
Nivolumab is a type of immunotherapy that blocks a protein that stops the immune system from locating and attacking cancer cells.
“This drug is the first of its kind to be offered to patients with metastatic oesophageal cancer. Nivolumab provides a more targeted approach to treating cancer, by helping the immune system to attack tumours,” said Ferguson.
Treatment options for advanced oesophageal squamous cell carcinoma have been very limited – those who are fit enough are offered further chemotherapy, but the benefit is small and side effects are rife, leading to hospital admission, impact on quality of life and poor prognosis.
In the Patient and Clinician Engagement (PACE) meeting ahead of the decision, patients spoke about how this type of cancer can be severe and debilitating, often with short life expectancy. They described their experiences of having difficulty swallowing, as well as vomiting, pain and general deterioration in health, which often progresses rapidly over just a few months.
This has a major impact on their quality of life, as well as their carers and families.
In Scotland, nivolumab will now be available to treat adult patients with oesophageal squamous cell carcinoma that cannot be removed by surgery and has either come back or spread to other parts of the body after initially being treated with chemotherapy.
Giving patients more time with loved ones
As well as considering views from the PACE meeting, the approval of nivolumab in Scotland is based on clinical evidence from a phase 3 trial (ATTRACTION-3), published in The Lancet Oncology in 2019.
This found the drug to significantly improve overall survival compared with treatment with the chemotherapy drug docetaxel (Taxotere) or paclitaxel (Taxol), increasing median overall survival by 2 and a half months.
Whilst this may not seem like a drastic improvement, it was considered clinically relevant by the European Medicines Agency (EMA) due to the poor outlook of patients with this advanced disease, giving them precious extra time with loved ones. The SMC took the EMA’s assessment of the drug into account during their decision making.
“Studies have shown that nivolumab can extend the time patients survive with advanced oesophageal cancer by several months, and it has been shown to work for other types of cancer too,” added Ferguson.
Cancer Research UK has previously funded trials of nivolumab for other cancer types, including the CONFIRM trial that looked at using it to treat mesothelioma – cancer in the lining covering some outer of organs – that had returned after chemotherapy.
The charity also supported a trial researching its effect on certain cancers that have spread to another part of the body or come back after treatment.
