November 18, 2023 Source: drugdu 44
AstraZeneca (AZ) has shared positive results from a late-stage study of its immunotherapy Imfinzi (durvalumab) when used as part of a combination treatment in a subset of patients with hepatocellular carcinoma (HCC), the most common type of liver cancer.
The phase 3 EMERALD-1 trial has been evaluating Imfinzi plus transarterial chemoembolisation (TACE) followed by Imfinzi with or without Genentech’s Avastin (bevacizumab) until progression versus TACE alone in more than 600 patients with unresectable HCC eligible for embolisation.
Approximately 75% of all primary liver cancers in adults are HCC and up to 30% of patients 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.
Despite being the standard of care in this setting, most of those who receive embolisation experience rapid disease progression or recurrence.
"Patients with liver cancer eligible for embolisation experience high rates of progression or recurrence and do not have the opportunity for early intervention with effective systemic therapy,” said Dr Riccardo Lencioni, principal investigator in the trial.
According to the results from EMERALD-1, Imfinzi in combination with TACE and bevacizumab demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of progression-free survival versus TACE alone, and the safety profile for the combination treatment was found to be consistent with the known profile of each medicine.
The trial will now continue to follow its secondary endpoint of overall survival.
"These results for Imfinzi plus bevacizumab have the potential to reshape the treatment of this complex disease with a poor prognosis by showing for the first time that adding an immunotherapy combination to TACE significantly improves progression-free survival,” said Lencioni.
Imfinzi is already approved in combination with AZ's Imjudo (tremelimumab) in unresectable HCC in the US, EU, Japan and other countries worldwide.
Susan Galbraith, executive vice president, oncology research and development, AZ, 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 this 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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