AstraZeneca (NASDAQ:AZN) has revealed encouraging results from the ongoing phase III EMERALD-I study, assessing Imfinzi (durvalumab) as part of a combination therapy for hepatocellular carcinoma (HCC), the most prevalent form of liver cancer.
The EMERALD-I study investigates the efficacy of Imfinzi in combination with bevacizumab and transarterial chemoembolization (TACE) compared to TACE alone for treating unresectable HCC in eligible patients for embolization. The study has successfully met its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in progression-free survival (PFS).
Data from the study indicates that the Imfinzi combination reduces the risk of disease progression or death in HCC patients by 23%, compared to those treated with TACE alone. The current standard of care for unresectable HCC involves embolization, a procedure that blocks the blood supply to the tumor while delivering chemotherapy or radiation therapy directly to the liver. Despite 20-30% of HCC patients being eligible for embolization, disease progression rates remain high.
For patients treated with the Imfinzi combination, the median PFS was 15 months, compared to 8.2 months for those receiving TACE alone. The study also demonstrated clinical benefit in the secondary endpoint of time to progression (TTP), with patients on the Imfinzi combination achieving a median TTP of 22 months versus 10 months in the TACE-only group.
However, the Imfinzi combination did lead to an increase in the rate of grade 3 or 4 treatment-related adverse events. Approximately 45.5% of patients receiving the combination experienced adverse events, compared to 23% of those treated with TACE.
Despite a 1.6% year-to-date decline in AstraZeneca’s shares, contrasting with the industry’s 16.7% rise, the company is discussing the results with regulatory authorities. A regulatory filing is planned after obtaining final results on the key secondary endpoint of overall survival (OS).
If approved, this would mark the second approval for Imfinzi in the HCC indication, complementing its existing authorization in combination with Imjudo for treating adult patients with unresectable HCC. Imfinzi, with multiple approvals in lung cancer, biliary tract cancer, and ongoing research across various cancer types, is a focal point for AstraZeneca’s efforts to fortify its oncology business.
In a separate development, AstraZeneca announced the first regulatory approval in Japan for its C5 inhibitor danicopan, marketed as Voydeya, to treat adults with paroxysmal nocturnal haemoglobinuria (PNH). Regulatory submissions for the drug are currently under review in multiple jurisdictions. AstraZeneca’s oncology business has shown robust performance, contributing to a 20% year-over-year rise in total revenues from the Oncology business to $13.5 billion in the first nine months of 2023. The company remains committed to expanding its oncology portfolio through label expansions and advancing pipeline candidates, intending to develop treatments for various cancer forms.
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