AstraZeneca’s Imfinzi Combination Becomes First Approved Immunotherapy Regimen For Biliary Tract Cancer

The US FDA has approved AstraZeneca’s Imfinzi (durvalumab) in combination with gemcitabine and cisplatin chemotherapy for adults with locally advanced or metastatic biliary tract cancer (BTC). 

This is the first time an immunotherapy-based treatment is approved for BTC, which consists of rare and aggressive cancers of the bile ducts and gallbladder. Surgery and chemotherapy have typically been the standard of care for the treatment of BTC.

Reducing Risk Of Death By 20%

The US approval for Imfinzi is based on results from the Phase 3 Topaz-1 trial, where Imfinzi plus chemotherapy reduced the risk of death by 20% versus chemotherapy alone. The two-year survival rate for patients treated with the Imfinzi combination was 25% compared to 10% in the chemotherapy group. 

Notably, the Imfinzi combination did not cause any new serious side effects. The most common adverse events included anemia, neutropenia, nausea, and fatigue.

“For the first time, patients in the US with advanced biliary tract cancer have an immunotherapy-based treatment option that meaningfully extends survival and is well-tolerated,” said Dave Fredrickson, Executive Vice President, Oncology Business Unit, AstraZeneca.

A Checkpoint Inhibitor For Cancer 

Imfinzi is a monoclonal antibody that blocks the PD-L1 protein expressed by tumor cells to evade the immune system. Besides BTC, the immunotherapy has been approved for unresectable Stage 3 non-small cell lung cancer (NSCLC) and extensive-stage small cell lung cancer (ES-SCLC) in many global markets. 

While the checkpoint inhibitor was originally approved in the US in 2017 for metastatic bladder cancer, AstraZeneca voluntarily withdrew the drug last year after it disappointed in a confirmatory trial.

The withdrawal has little impact on Imfimzi’s other indications, approved or otherwise, said AstraZeneca. According to a financial report published in February, Imfinzi brought in revenues of $2.4 billion in 2021, mainly due to high demand for its lung cancer indications.  

Author

Joy Lin

Without knowledge, there is no imagination. Without imagination, knowledge is meaningless