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 (Thursday, 14 May), 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 and even cure. 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.
Read the full final draft guidance for durvalumab in combination for
neoadjuvant and adjuvant treatment of resectable gastric and
gastro-oesophageal junction cancer.
ENDS
Notes to editors
- Durvalumab, also known as Imfinzi and made by AstraZeneca, is
recommended with FLOT chemotherapy both before surgery
(neoadjuvant) and after surgery (adjuvant), then on its own as a
post-surgery treatment, for adults with resectable gastric or
gastro-oesophageal junction adenocarcinoma. [link]
- Marketing authorisation for durvalumab in this indication was
granted by the MHRA on Monday, 27 April.
- Around 5,250 people in England are diagnosed with stomach
cancer each year. An estimated 1,526 people in England are
eligible for this treatment.
