AstraZeneca (AZ) has shared positive results from a late-stage study evaluating its immunotherapy Imfinzi (durvalumab) in a subset of patients with hepatocellular carcinoma (HCC), the most common type of liver cancer.
The phase 3 EMERALD-1 trial has been comparing Imfinzi plus transarterial chemoembolisation (TACE), followed by Imfinzi with or without Genentech’s Avastin (bevacizumab), until progression against TACE alone in more than 600 patients with unresectable HCC eligible for embolisation.
About 75% of all primary liver cancers in adults are HCC and up to 30% of HCC patients are eligible for embolisation, a procedure that blocks blood supply to the tumour and can also deliver chemotherapy or radiation therapy directly to the liver.
Despite being the standard of care in this setting, AZ outlined that most patients who receive embolisation experience rapid disease progression or recurrence.
According to the results from EMERALD-1, which were presented at this year’s American Society of Clinical Oncology Gastrointestinal Cancers Symposium, Imfinzi in combination with TACE and Avastin reduced the risk of disease progression or death by 23% compared to TACE alone.
Median progression-free survival (PFS) was 15 months in patients treated with the Imfinzi combination versus 8.2 months with TACE and the PFS benefit was “generally consistent” across key pre-specified subgroups, AZ said.
The company added that the secondary endpoint of time to progression “further supports the clinical benefit” of the Imfinzi combination in this setting, at a median of 22 months versus ten months for TACE. The trial will continue to follow the key secondary endpoint of overall survival.
Susan Galbraith, executive vice president, oncology research and development, AZ, said: “With Imfinzi-based treatment, patients with liver cancer eligible for embolisation lived nearly seven additional months before their disease progressed.
“We are discussing these positive EMERALD-1 data with global regulatory authorities while awaiting the final overall survival results from the trial.”
Imfinzi is already approved in combination with AZ’s Imjudo (tremelimumab) in unresectable HCC in the US, EU, Japan and other countries worldwide.
Lead investigator in EMERALD-1, Bruno Sangro, from Clínica Universidad de Navarra in Spain, said: “Adding [Imfinzi] and [Avastin] to TACE reduced the risk of disease progression or death by 23% for patients with liver cancer eligible for embolisation, showing for the first time that combining a systemic treatment with TACE meaningfully improves this clinically relevant outcome in earlier-stage disease.”