The treatment is indicated for patients with locally advanced biliary tract cancer which cannot be surgically resected or has metastasised. Credit: yay jormami / Shutterstock.com.

The Scottish Medicines Consortium and the UK’s National Institute of Health and Care Excellence (NICE) have recommended the use of AstraZeneca’s durvalumab (Imfinzi) as a first-line option to treat adults with advanced biliary tract cancers in England and Scotland.

The immunotherapy should be used with the chemotherapy drugs gemcitabine plus cisplatin.  

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The treatment is indicated for patients with locally advanced biliary tract cancer which cannot be surgically resected or has metastasised.

Durvalumab is the first immunotherapy offered as an initial treatment for biliary tract cancers on the NHS.

The combination regimen will treat biliary tract cancers, including gallbladder cancer, ampullary cancers and bile duct cancer or cholangiocarcinoma.

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More than 700 individuals in England will be eligible for the treatment following NICE’s final decision in January 2024. 

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The latest decision by the England and Scotland authorities is based on data from the Phase III TOPAZ-1 clinical trial of durvalumab plus gemcitabine and cisplatin.

In the trial, 685 subjects were randomised to receive either durvalumab plus gemcitabine and cisplatin or gemcitabine and cisplatin along with a placebo. 

The combination regimen enhanced the survival rate of biliary tract cancer patients and the time to disease progression.  

Durvalumab almost exceeded in doubling the two-year overall patient survival. 

Durvalumab can induce the immune system to detect and kill cancer cells by using a PD-L1 protein on their surface and binding to the cells. 

The treatment is delivered into the bloodstream via a drip and has been licensed through the international programme, Project Orbis.

Decisions by NICE are also frequently accepted in Wales and Northern Ireland, meaning that durvalumab may be available to patients across the UK.