A new treatment option for operable stomach cancer
NICE has approved durvalumab (brand name Imfinzi®) in combination with FLOT chemotherapy for use on the NHS in England. Durvalumab is an immunotherapy drug developed by AstraZeneca and studied in the MATTERHORN trial. It is given in combination with FLOT chemotherapy and is suitable for people with operable (stage 1b to 3) stomach and gastro-oesophageal cancers.
Why this approval matters
This decision brings immunotherapy to people on the curative treatment pathway for the first time on the NHS in England for this group of patients.
For nearly a decade, FLOT has been the standard of care for operable stomach cancer. While it represented progress at the time, recurrence rates have remained high despite radical surgery and intensive chemotherapy. The approval of durvalumab + FLOT marks the first major advance in curative-intent treatment for this disease in almost ten years.
What is durvalumab?
Durvalumab is a PD-L1 immune checkpoint inhibitor (immunotherapy drug). It is a monoclonal antibody that targets and binds to PD-L1 on the surface of tumour and immune cells, preventing tumour cells from escaping immune detection.
Who can have durvalumab?
Durvalumab + FLOT chemotherapy is approved for adults in England who:
- Have stomach or gastro-oesophageal junction adenocarcinoma
- Are stage 1b-3, and are on the operable, curative-intent pathway
Separate appraisal processes and timelines operate in Scotland, Wales and Northern Ireland. If you have stomach cancer in these territories, ask your team about availability.
What testing do you need?
No biomarker testing is needed as durvalumab + FLOT is approved for all eligible patients who have operable stomach or gastro-oesophageal adenocarcinoma regardless of PD-L1 status.
What can durvalumab + FLOT do?
The MATTERHORN trial added durvalumab to chemotherapy before and after surgery. This large international trial found that the combination of durvalumab + FLOT (also known as D-FLOT) improved outcomes compared with chemotherapy alone.
This included:
- A complete response to treatment in more people, where cancer could not be seen in the tissue removed at surgery
- A longer time on average before cancer returned, with the cancer not returning in the period of follow-up in a higher number of patients.
- Longer survival for more people.
Stomach Cancer UK’s involvement
Stomach Cancer UK was a registered stakeholder in the NICE appraisal process. We submitted a detailed patient group submission drawing on interviews with patients, caregivers and families. We also nominated two patient experts and two clinical experts to ensure that lived experience and specialist insight were fully represented during appraisal. Stomach Cancer UK believes it is essential that decisions about new treatments reflect both robust clinical evidence and the realities faced by patients and families.
Durvalumab + FLOT offers people with operable stomach cancer a stronger chance of remaining cancer-free after radical treatment. Patients on the curative pathway endure life-changing surgery and intensive chemotherapy with the hope of a cure, yet recurrence and the fear that the cancer will return have remained a heavy burden. Bringing immunotherapy into this setting meaningfully shifts that balance.Sheena Dewan, Executive Director, Stomach Cancer UK
This approval gives patients more than incremental improvement – it can give them more time. More time with family, more time at work, and more time living beyond treatment. We welcome NICE’s decision and the careful consideration of the evidence that led to it.
What happens next
Durvalumab + FLOT will now be available to eligible patients through NHS England specialist centres. All patients with operable disease are eligible, regardless of PD-L1 status.
However, the decision to include immunotherapy will be made by the multidisciplinary team, based on an individual’s performance status, other health conditions and their ability to tolerate the addition of immunotherapy to chemotherapy.
If you are newly diagnosed in England, you can ask your cancer team about adding durvalumab to FLOT chemotherapy and whether it could be an option for you. You may wish to print and bring this page to your appointment to help you discuss your options with your oncologist.
Good to know: NHS Scotland has its own separate appraisal process through the Scottish Medicines Consortium (SMC). In Wales, a positive NICE recommendation requires the NHS to make durvalumab available within two months. In Northern Ireland, a positive NICE decision would be implemented by the Department of Health (NI) for use in HSC.
For more information, visit NICE