Results from the EMERALD-1 Phase III trial have showcased positive high-level outcomes for AstraZeneca's IMFINZI (durvalumab) when combined with transarterial chemoembolization (TACE) and bevacizumab.
This combination exhibited a statistically significant and clinically meaningful improvement in the progression-free survival (PFS) primary endpoint compared to TACE alone in patients with hepatocellular carcinoma (HCC) eligible for embolization.
The trial is ongoing, focusing on the secondary endpoint of overall survival (OS).
Hepatocellular carcinoma is the most prevalent form of liver cancer, ranking as the third-leading cause of cancer-related deaths, with approximately 900,000 new cases diagnosed annually worldwide.
About 20-30% of patients are suitable for embolization, a procedure that restricts blood supply to the tumor while allowing the delivery of chemotherapy or radiation therapy directly to the liver. Despite being the standard of care, most patients undergoing embolization face rapid disease progression or recurrence.
Dr. Riccardo Lencioni, the principal investigator in the trial, emphasized that patients eligible for embolization often experience high rates of progression or recurrence without the opportunity for early intervention using effective systemic therapy.
The results for durvalumab plus bevacizumab suggest a potential shift in treating this challenging disease, demonstrating, for the first time, that adding an immunotherapy combination to TACE significantly enhances progression-free survival.
Susan Galbraith, Executive Vice President, Oncology R&D at AstraZeneca, expressed optimism about the potential of IMFINZI-based treatment in EMERALD-1, anticipating a groundbreaking application of immunotherapy in earlier stages of liver cancer.
The company looks forward to discussing these findings with regulatory authorities and monitoring the maturation of survival data over time to bring this innovative treatment option to patients.
The safety profiles for IMFINZI and TACE plus bevacizumab were consistent with the known profiles of each medicine, and there were no new safety findings. The detailed data will be presented at an upcoming medical meeting and shared with regulatory authorities.
AstraZeneca is actively engaged in a comprehensive clinical development program to further evaluate IMFINZI across various gastrointestinal cancer settings.
This includes combinations with bevacizumab in adjuvant HCC (EMERALD-2) and with IMJUDO (tremelimumab-actl), lenvatinib, and TACE in embolization-eligible HCC (EMERALD-3).
