PFS Significantly Extended: AstraZeneca's Durvalumab Combination Therapy Meets Primary Endpoint in Phase III EMERALD-1 Trial

On January 19, AstraZeneca announced positive results from the Phase III EMERALD-1 study of Imfinzi (durvalumab) in combination with transarterial chemoembolization (TACE) and bevacizumab for the treatment of patients with hepatocellular carcinoma (HCC) suitable for embolization. In the primary endpoint, progression-free survival (PFS), the Imfinzi combination therapy group showed a statistically significant and clinically meaningful improvement compared to TACE alone. This is also the world's first Phase III study to demonstrate that systemic therapy combined with TACE can improve clinical outcomes for patients.

Hepatocellular carcinoma is the most common type of liver cancer, with approximately 20%-30% of hepatocellular carcinoma patients being eligible for transarterial chemoembolization (TACE) treatment. TACE is a procedure that blocks the blood supply to the tumor and can also deliver chemotherapy or radiation therapy directly to the liver. Although TACE is the standard treatment in this scenario, the majority of patients receiving TACE treatment will experience disease progression or recurrence within 8 months.

In the EMERALD-1 study, compared with TACE alone, the combination of Imfinzi, TACE, and bevacizumab reduced the risk of disease progression or death by 23% (Hazard Ratio [HR]: 0.77; 95% Confidence Interval [CI] 0.61-0.98; p=0.032). The median PFS in the Imfinzi combination group was 15 months, compared to 8.2 months in the TACE group. The observed PFS benefit was generally consistent across pre-specified key subgroups.

The secondary endpoint of time to progression (TTP) further supports the clinical benefit of the Imfinzi combination therapy group, with a median TTP of 22 months compared to 10 months in the TACE group (HR: 0.63; 95% CI 0.48-0.82). These data were also presented at the 2024 American Society of Clinical Oncology (ASCO) Gastrointestinal (GI) Cancers Symposium.

The trial will continue as planned to assess the key secondary endpoint of overall survival (OS).

In terms of gastrointestinal cancers, AstraZeneca has a broad clinical development program that can further evaluate the efficacy of Imfinzi across various settings. In addition to the EMERALD-1 study, Imfinzi is also being investigated in combination with bevacizumab as adjuvant treatment for HCC (EMERALD-2), in combination with Imjudo, lenvatinib, and TACE for the treatment of unresectable HCC (EMERALD-3), resectable gastric and gastroesophageal junction cancer (MATTERHORN), and locally advanced esophageal cancer (KUNLUN). In June 2023, the Phase III MATTERHORN trial evaluating Imfinzi combined with standard-of-care chemotherapy as neoadjuvant treatment for gastric and gastroesophageal junction cancer met the key secondary endpoint of pathological complete response.

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