AstraZeneca's Durvalumab Approved in China for First-Line Treatment of Biliary Tract Cancer

On November 13, the official website of the National Medical Products Administration (NMPA) showed that AstraZeneca's new indication for durvalumab has been approved in China. The speculated indication is for first-line treatment in combination with chemotherapy (gemcitabine plus cisplatin) for locally advanced or metastatic biliary tract cancer (BTC).

In September 2022, durvalumab was approved in the United States for the treatment of adult patients with locally advanced or metastatic BTC, primarily based on positive data from the Phase III TOPAZ-1 study. TOPAZ-1 is a randomized, double-blind, placebo-controlled clinical trial that enrolled a total of 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.

In October 2021, the interim analysis results of AstraZeneca's TOPAZ-1 trial 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.

In September 2022, AstraZeneca announced additional follow-up results from the TOPAZ-1 trial. After an extended follow-up period of 6.5 months, the clinical efficacy of durvalumab combined with chemotherapy improved, reducing the risk of death by 24% compared to chemotherapy alone. The updated median OS was 12.9 months, compared to 11.3 months for chemotherapy alone. The number of patients surviving at two years was more than double that of chemotherapy alone (23.6% vs. 11.5%).

Regardless of disease status, tumor location, or PD-L1 expression, the results were consistent across all pre-specified subgroups. Additionally, OS benefits were observed in patients with stable tumor size (disease stabilization) as well as in those with shrinking or disappearing tumors (responders).

In terms of safety, durvalumab combined with chemotherapy still demonstrated good tolerability, with no new safety signals observed during the longer follow-up period. 60.9% of patients receiving durvalumab combined with chemotherapy and 63.5% of patients receiving chemotherapy alone experienced grade 3 or 4 treatment-related AEs. Compared with chemotherapy alone, durvalumab combined with chemotherapy did not increase the discontinuation rate due to adverse events (AEs) (8.9% for durvalumab combined with chemotherapy vs. 11.4% for chemotherapy).

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, this product has been approved for multiple oncology indications in the United States, including urothelial carcinoma, extensive-stage small cell lung cancer, biliary tract cancer, hepatocellular carcinoma, and non-small cell lung cancer.

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