AstraZeneca’s Imfinzi (Durvalumab) Plus Chemotherapy Approved in China as First Immune Therapy for Locally Advanced or Metastatic Biliary Tract Cancer

On November 14, AstraZeneca announced, Imfinzi^®(English trade name: IMFINZI^®(Generic name: Durvalumab) was officially approved by the National Medical Products Administration (NMPA) on November 7 for use in combination with gemcitabine and cisplatin as a first-line treatment for adult patients with locally advanced or metastatic biliary tract cancer (BTC). As the first immunotherapy regimen approved in China specifically for biliary tract cancer, the combination of durvalumab and chemotherapy marks a significant step forward for AstraZeneca in the field of hepato-biliary tumors.

The approval of durvalumab for use in combination with chemotherapy by the China National Medical Products Administration was primarily based on the results of the Phase III clinical study TOPAZ-1. The interim analysis showed that, compared with chemotherapy alone, the combination of durvalumab and chemotherapy reduced the risk of death by 20% (Hazard Ratio [HR] 0.80; 95% Confidence Interval [CI] 0.66-0.97; p=0.021). Among patients receiving durvalumab combined with chemotherapy, 24.9% were still alive after two years, compared to 10.4% among those receiving chemotherapy alone. The combination of durvalumab and chemotherapy provided benefits regardless of PD-L1 expression levels or tumor location. In subgroup analyses, the addition of durvalumab demonstrated consistent trends in improving overall survival and progression-free survival.

Biliary tract cancer is a group of malignant tumors originating from the bile ducts and gallbladder that progress rapidly. It accounts for approximately 3% of all digestive system tumors and is showing an increasing trend year by year in China. For biliary tract cancer, radical surgery is a potentially curative treatment, but its clinical efficacy is limited, and clinical needs are far from being met.

About Durvalumab

Durvalumab is a humanized PD-L1 monoclonal antibody that blocks the binding of PD-L1 to PD-1 and CD80, thereby preventing tumor immune escape and lifting the suppression of immune responses.

Based on the results of the Phase III clinical trial HIMALAYA study, durvalumab in combination with tremelimumab has been approved in the United States, the European Union, Japan, and several other countries for the treatment of unresectable hepatocellular carcinoma (HCC).

In addition to the indications for gastrointestinal tumors, durvalumab is also an approved immunotherapy with a curative intent for patients with unresectable stage III non-small cell lung cancer (NSCLC).

Based on the results of the Phase III clinical trial CASPIAN study, durvalumab has also been approved in the United States, the European Union, Japan, China, and many other countries worldwide for the treatment of extensive-stage small cell lung cancer (SCLC). Additionally, based on the results of the Phase III clinical trial POSEIDON study, the combination of durvalumab, tremelimumab, and chemotherapy has been approved in the United States, the European Union, and Japan for the treatment of metastatic NSCLC. Durvalumab has also been approved in a few countries for the treatment of previously treated advanced bladder cancer patients.

Since its first approval in May 2017, more than 200,000 patients have been treated with durvalumab.

As part of the overall development plan, durvalumab is currently being explored for its therapeutic potential in SCLC, NSCLC, bladder cancer, various gastrointestinal tumors, and other solid tumors, either as a monotherapy or in combination with other anticancer drugs.

Editor: Mu Mian

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