Nivolumab approved in England for patients with oesophageal cancer

13 May 2021
Nivolumab approved in England for patients with oesophageal cancer

NICE recommends nivolumab as first immunotherapy for patients in England with unresectable advanced oesophageal squamous cell cancer who have failed chemotherapy

Bristol Myers Squibb (BMS) today announced that the National Institute for Health and Care Excellence (NICE) has issued a Final Appraisal Document (FAD) recommending Opdivo (nivolumab) as the first immuno-oncology monotherapy for the treatment of unresectable advanced, recurrent or metastatic oesophageal squamous cell cancer (OSCC) in England, in patients who have previously failed chemotherapy.

The landmark decision signifies the first immuno-oncology treatment to be recommended by NICE for patients with unresectable advanced OSCC, regardless of biomarker presence.

Surgery to remove the cancer or tumour has been unsuccessful or is not an option for patients diagnosed with unresectable advanced OSCC.

The current primary cancer treatment for OSCC is chemotherapy, with 45% of patients receiving it as part of their curative or palliative cancer treatment.

With the availability of nivolumab on the NHS, OSCC patients in England will now have access to an alternative treatment when chemotherapy

“Patients with unresectable advanced oesophageal squamous cell cancer have been waiting for this approval for a long time and it’s excellent to see that NICE has now made the decision to provide immunotherapy as an alternative treatment, when chemotherapy fails.” said Julie Harrington, Chief Executive Officer, Guts UK. This positive step provides new optimism to patients and their families.

There are two main types of oesophageal cancer; squamous cell cancer and adenocarcinoma. Squamous cell cancer forms in the inner lining of the oesophagus, and is the second most common type of oesophageal cancer in the UK.

Oesophageal cancer represents 3% of all new cancer diagnoses in the UK, with approximately 9,200 new cases each year. Of these, around three-quarters are diagnosed at a late stage (where the cancer has spread to the other parts of the body).

While oesophageal cancer survival  rates have improved threefold over the last 40 years in the UK, only 16% of people diagnosed with advanced oesophageal cancer will survive for five years or more.

“With treatment options limited to chemotherapy, surgery, and radiotherapy, NICE’s recommendation is a landmark decision for advancing treatment and care in unresectable advanced oesophageal squamous cell cancer, by providing access to nivolumab to those who urgently need it.” said Dr Elizabeth Smyth, Consultant in gastrointestinal oncology at Addenbrooke’s Hospital in Cambridge and NICE expert for this decision.

“It is important that we continue to provide innovative therapies in rare cancers, such as unresectable advanced oesophageal squamous cell cancer, as we look to evolve the future of cancer care.”

This NICE recommendation is supported by three-year data from the Phase III randomised ATTRACTION-3 study, which demonstrated a significant improvement in overall survival and a favourable safety profile with nivolumab compared to taxane chemotherapy (CT).

The median overall survival was 10.91 months with nivolumab versus 8.51 months with CT. The overall survival rates of patients with nivolumab and CT were 20.2% and 13.5% at 24 months, and 15.3% and 8.7% at 36 months respectively.

No new safety signals were detected during the three-year follow-up.

Source: BMS