Clinical Trials
AstraZeneca has announced positive results from the EMERALD-1 phase 3 trial for Imfinzi (durvalumab) in combination with transarterial chemoembolisation (TACE) and bevacizumab for the treatment of patients with hepatocellular carcinoma (HCC) eligible for embolisation.
The trial showed a statistically significant and clinically meaningful improvement in the primary endpoint of progression-free survival (PFS) compared to TACE alone for this indication. The trial will continue in order to assess its secondary endpoint of overall survival (OS).
Safety profiles for Imfinzi and TACE plus bevacizumab remained consistent with the drugs’ known profiles, with no new safety findings emerging.
Full data from the trial is expected to be presented at an upcoming medical meeting as well as being shared with the relevant regulatory authorities.
Susan Galbraith, executive vice president, Oncology Research and Development at AstraZeneca, commented: “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.”
Dr Riccardo Lencioni, professor and director of the Cancer Imaging Program in the Department of Diagnostic and Interventional Radiology of Pisa University Hospital in Pisa, Italy, and principal investigator in the trial, added: “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. These results for durvalumab 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.”