The human monoclonal antibody blocks the tumour’s immune-evading mechanisms by inhibiting the PD-L1 protein. Credit: Mohammed Haneefa Nizamudeen via Getty Images.

AstraZeneca has reported positive topline results from the EMERALD-1 Phase III clinical trial of Imfinzi (durvalumab) to treat hepatocellular carcinoma (HCC). 

The trial investigated Imfinzi plus transarterial chemoembolisation (TACE) and Roche’s Avastin (bevacizumab) versus TACE alone in HCC patients who are eligible for embolisation, a procedure that blocks the blood supply to the tumour and can deliver chemotherapy or radiation therapy directly to the liver.  

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The trial met its primary endpoint, demonstrating statistically significant and clinically meaningful improvement in progression-free survival (PFS) in the patient population. The study continues to follow the secondary endpoint of overall survival (OS). 

The randomised, double-blind, placebo-controlled, multicentre trial (NCT03778957) enrolled 616 patients across 18 countries.  

Imfinzi is a human monoclonal antibody that inhibits the PD-L1 protein, blocking the tumour’s immune-evading mechanisms.  

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AstraZeneca oncology executive vice-president Susan Galbraith said: “These positive results for Imfinzi-based treatment in EMERALD-1 may bring the potential of immunotherapy to patients with earlier stages of liver cancer. We look forward to discussing these data with regulatory authorities and seeing the survival data mature over time, which will be important as we aim to bring this novel treatment option to patients.” 

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Imfinzi has been approved for the treatment of different cancer types, including biliary tract cancer, unresectable hepatocellular carcinoma, non-small lung cancer (NSLC), small-cell lung cancer (SCLC) and more indications in the US, EU and Japan, based on the CASPIAN and POSEIDON Phase III trials.  

The company is also conducting further clinical trials to evaluate Imfinzi in various gastric and gastroesophageal junction cancer settings gastrointestinal cancer settings (MATTERHORN) and locally advanced oesophageal cancer (KUNLUN).  

Imfinzi generated $1.9bn in the first half of 2023, as per AstraZeneca’s H1 2023 results announcement. According to GlobalData, Imfinzi is forecast to generate $6.8bn in sales by 2029. 

GlobalData is the parent company of Clinical Trials Arena.