AstraZeneca Submits New Indication Application for Durvalumab (Imfinzi) in China for First-Line Treatment of Locally Advanced or Metastatic Biliary Tract Cancer

On March 11, the CDE website showed that AstraZeneca's durvalumab (Imfinzi) had submitted an application for marketing authorization in China. Based on publicly available clinical trial information and AstraZeneca's 2022 financial report, it is speculated that the indication applied for this time is for first-line treatment in combination with chemotherapy for locally advanced or metastatic biliary tract cancer (BTC).

In September 2022, durvalumab was approved in the United States for first-line treatment of BTC in combination with chemotherapy based on positive results from the Phase III TOPAZ-1 study. This study was a randomized, double-blind, placebo-controlled clinical trial that enrolled 685 patients, aiming to evaluate the efficacy and safety of durvalumab combined with chemotherapy compared to placebo combined with chemotherapy as a first-line treatment for patients with advanced BTC.

The results showed that, compared with the placebo group, the overall survival (OS) and progression-free survival (PFS) of patients in the durvalumab group were improved both statistically and clinically, reducing the risk of death and disease progression by 20% and 25%, respectively.

Durvalumab, a PD-L1 monoclonal antibody developed by AstraZeneca, was approved for marketing in the United States in May 2017 for the treatment of locally advanced or metastatic urothelial carcinoma. To date, the product has been approved for five oncology indications in the United States: 1) Urothelial carcinoma; 2) Extensive-stage small cell lung cancer; 3) Biliary tract cancer; 4) Hepatocellular carcinoma; 5) Non-small cell lung cancer.

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