Over 1,500 people set to benefit from first immunotherapy for aggressive stomach cancer
The targeted treatment helps people live longer and can help prevent the disease from returning.
More than 1,500 people a year with an aggressive form of stomach cancer are set to receive a new treatment available on the NHS from today, after NICE recommended durvalumab - the first immunotherapy for people with this form of cancer.
Durvalumab, also known as Imfinzi and made by AstraZeneca, is recommended for adults whose stomach (gastric and gastro-oesophageal junction) cancer has not spread extensively and can be removed through surgery.
The drug received its marketing authorisation from the Medicines and Healthcare products Regulatory Agency (MHRA) just 17 days ago and NICE’s guidance was produced using a simpler assessment process, meaning patients will get access to the treatment faster than if the standard process had been used.
Gastric and gastro-oesophageal junction cancer - where tumours form in the stomach or where it meets the oesophagus - is frequently diagnosed at an advanced stage. Even when surgery is possible, the cancer returns in many patients, and only around half of people survive five years after diagnosis.
Clinical trial evidence shows that durvalumab plus FLOT chemotherapy (fluorouracil, leucovorin, oxaliplatin and docetaxel) before and after surgery, then on its own after surgery, increases how long people have before their cancer gets worse and how long they live compared with chemotherapy alone.
In one trial, people taking durvalumab had on average just over 40 months without their cancer getting worse, compared with just over 32 months for people taking chemotherapy alone. Of the 948 people who took durvalumab as part of the trial, 68.6% lived for three years compared with 61.9% taking the standard chemotherapy treatment.
Patient and clinical experts told NICE that stomach cancer coming back after surgery is common, meaning the current long-term prognosis for patients is poor.
Durvalumab is given by intravenous infusion every four weeks. It works by blocking the PD-L1 protein, which cancer cells use to hide from the body's immune system. The drug allows the immune system to identify and attack cancer cells.
NICE applied its light-touch, streamlined process to its assessment of durvalumab, enabling a positive final draft to be made faster than under its usual process, without the need for a committee meeting.
Helen Knight, director of medicines evaluation at NICE, 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.
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.
Sheena Dewan, Executive Director at Stomach Cancer UK, said: “Stomach Cancer UK welcomes NICE’s positive appraisal of durvalumab in combination with FLOT for people with operable stomach and gastro-oesophageal junction cancer in England. This is the first major advance in curative-intent treatment for stomach cancer in nearly a decade.
"Adding immunotherapy to perioperative chemotherapy offers a real opportunity for lower recurrence and longer survival. For too long, patients have been enduring the dual burden of life-altering surgery and high rates of recurrence.
This treatment gives individuals and families living with the constant fear that the cancer will return a meaningful opportunity for more time with loved ones, more time at work and more time to live well beyond treatment. We are grateful to NICE for its careful consideration of the evidence and for recognising the importance of progress in a cancer that has historically had limited available treatment options.
The company has a confidential commercial arrangement in place which makes durvalumab available to the NHS with a discount.