AstraZeneca’s Imfinzi (durvalumab) will become the first immunotherapy available for UK National Health Service (NHS) patients with an aggressive form of stomach cancer, after a regulatory nod from the National Institute of Health and Care Excellence (NICE).
NICE has recommended the drug for adults with stomach cancer that has not spread extensively and can be removed through surgery. This includes gastric and gastro-oesophageal junction cancers, which are frequently diagnosed at an advanced stage.
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Data from AstraZeneca’s MATTERHORN Phase III trial (NCT04592913) demonstrated that patients taking Imfinzi in combination with standard-of-care (SoC) FLOT (fluorouracil, leucovorin, oxaliplatin, and docetaxel) chemotherapy had a significant and clinically meaningful improvement in the primary endpoint of event-free survival (EFS). The combo regimen, given before and after surgery – then Imfinzi alone – increases how long people have before their cancer gets worse and how long they live compared with chemotherapy alone.
In a final overall survival (OS) analysis, the Imfinzi and FLOT perioperative regimen reduced the risk of death by 22% compared with chemotherapy alone. An estimated 69% of patients treated with the Imfinzi-based regimen were alive at three years compared with 62% in the FLOT-only arm.
Gastric cancer is the fifth leading cause of cancer death globally, with nearly one million people diagnosed each year. There are around 7,000 new cases of stomach cancer in the UK each year. While incidence rates are decreasing, stomach cancer has a poor prognosis. Around 16% of people diagnosed with stomach cancer in the UK survive their disease for ten years or more, as per the latest available data from 2018.
Helen Knight, NICE’s director of medicines evaluation, said: “Stomach cancer is a devastating disease with high rates of recurrence after surgery, so there is an urgent need for treatments like durvalumab that meaningfully extend both the length and quality of patients’ lives.”
Imfinzi is one of the early drugs to go through a new aligned pathway between NICE and the Medicines and Healthcare products Regulatory Agency (MHRA). The NHS recommendation comes just 17 days after marketing authorisation – previously this gap would have been much longer.
Knight added: “Being able to recommend this drug faster through our streamlined process will benefit thousands of people with this aggressive form of cancer. We are determined to ensure NHS patients in England have faster access to the most promising new treatments while providing value for the taxpayer.”
Imfinzi, which is given intravenously every four weeks, works by blocking the PD-L1 protein. This protein acts as a pro-tumorigenic factor in cancer cells, allowing evasion from the body’s immune system. Imfinzi, a monoclonal antibody (MAb), allows T-cells to identify and destroy tumour cells.
Stomach cancer is just one of several indications that Imfinzi holds marketing approval for. The immunotherapy was AstraZeneca’s second best-selling drug in 2025, generating $6bn globally. This was up 29% over 2024, owing to new launches in bladder and lung cancer.
