Durvalumab immunotherapy recommended for advanced bile duct cancers in England and Scotland

The immunotherapy durvalumab (Imfinzi) is now recommended as a first option for treating biliary tract cancers that are locally advanced, can’t be removed through surgery or have spread (metastasised) in adults in England and Scotland.  

It will be added to the existing treatment, a combination of the chemotherapy drugs gemcitabine and cisplatin.  

The recommendations, from the Scottish Medicines Consortium (SMC) and the National Institute of Health and Care Excellence (NICE), will make durvalumab the first immunotherapy available as a first-line (or initial) treatment on the NHS for biliary tract cancers, which include bile duct cancer (cholangiocarcinoma), gallbladder cancer and ampullary cancer.  

These rare and aggressive cancers are usually diagnosed at an advanced stage, when there are few treatment options beyond gemcitabine and cisplatin, which has been the standard of care for over a decade. The NICE committee responsible for the decision in England noted that the prognosis and quality of life with current chemotherapy is poor and that more treatment options are urgently needed. 

NICE estimates that just over 1,800 people in England are diagnosed with unresectable or advanced biliary tract cancers each year. Just over 700 people in England will be eligible to receive durvalumab when the NICE decision is finalised in January. 

NICE and the SMC made their decisions after consulting the results of the Phase III TOPAZ-1 trial, which showed that adding durvalumab to gemcitabine and cisplatin increases how long people with biliary tract cancers live and extends the time before their cancer progresses.  

The trial randomly assigned 685 patients to receive durvalumab alongside gemcitabine and cisplatin, or gemcitabine and cisplatin with a placebo. Estimates based on the results suggest that adding durvalumab could more than double two-year overall survival, although the exact extent of the improvement is unclear. 

Durvalumab is delivered to the blood using a drip. It stimulates the body’s immune system to fight cancer by seeking out cells with a protein called PD-L1 on their surface and attaching to them. The immune system then recognises the marked cells and kills them. 

The treatment was licenced through Project Orbis, an international programme to review and approve promising cancer drugs so patients can access innovative treatments faster. 

NICE decisions are usually adopted in Wales and Northern Ireland, so durvalumab is likely to be offered to patients across the whole of the UK.