Defining immunotherapy in combination with chemotherapy as first-line treatment of patients with advanced biliary tract cancer (durvalumab)

Narrative

Our work as part of the international multi-centre phase 3 study (TOPAZ-1 trial ) has changed the standard of care for patients with advanced biliary tract cancer. The trial showed that treatment with durvalumab plus chemotherapy significantly reduced the risk of death by 20% compared to chemotherapy alone.

In July 2022, this treatment was added to National Comprehensive Cancer Network (NCCN) guidelines as a preferred 1st-line therapy for locally advanced or metastatic BTC based on the data from TOPAZ-1.

In September 2022, the FDA approved the use of durvalumab (known as Imfinzi) plus chemotherapy for adults with locally advanced or metastatic biliary tract cancer.

In Nov 2022 European Society for Medical Oncology (ESMO) Biliary Tract Cancer Clinical Guidelines stated cisplatine-gemcitabine-durvalumab should be considered for the first-line treatment of advanced BTC based on TOPAZ-1.

In January 2024, Durvalumab plus gemcitabine and cisplatin was recommended as an option for treating locally advanced, unresectable, or metastatic biliary tract cancer in adults by NICE. The TOPAZ-1 trial was cited within the evidence used.

Impact date	2022
Category of impact	Health and wellbeing
Impact level	Benefit