Another potential approval may be coming into view for AstraZeneca’s Emerald program, as a combination regimen featuring its immunotherapies Imfinzi and Imjudo delivered positive results in certain liver cancer patients.
Data from the phase 3 Emerald-3 study indicated that the regimen, which is used alongside transarterial chemoembolization (TACE) and Lenvima, considerably extended progression-free survival compared with just TACE in patients with unresectable, locoregional hepatocellular carcinoma. Lenvima, a multikinase inhibitor, is marketed by Merck & Co. and Eisai.
However, it remains unclear whether the results will be sufficient for regulatory success. Overall survival, an important secondary goal that will weigh heavily in U.S. Food and Drug Administration decision-making, was not yet mature at the interim analysis, though the company noted a positive trend in its April 2 update.
The Emerald-3 findings mirror aspects of the earlier Emerald-1 trial conducted in a similar patient population eligible for TACE. In that study, a combination of Imfinzi, Avastin and TACE reduced the risk of disease progression or death by 23% compared with only TACE. As with Emerald-3, overall survival data were immature at the time, and AstraZeneca’s head of oncology R&D, Susan Galbraith, emphasized the importance of survival outcomes in this treatment setting.
That emphasis is underscored by a recent setback for Merck & Co., which discontinued efforts to secure approval for a similar liver cancer regimen combining Keytruda, Lenvima and TACE after it failed to demonstrate an overall survival benefit over TACE alone.
Emerald-1 has yet to report its final overall survival data and has not been included in recent regulatory submission plans outlined by AstraZeneca. Meanwhile, the company is engaging with global regulators regarding the Emerald-3 results while awaiting additional data from key secondary endpoints, Galbraith said.
Regarding Emerald-1, an AstraZeneca spokesperson indicated that further data will be shared in the future, with regulatory strategies to be updated accordingly.
Liver cancer was also the entry point for Imjudo’s market debut in 2022, when it was approved in combination with Imfinzi for unresectable hepatocellular carcinoma, the most persistent form of liver cancer.
Patients eligible for embolization procedures such as TACE typically have earlier-stage disease. AstraZeneca estimates that more than 200,000 patients fall into this category in 2026, though most experience disease progression or recurrence within six to ten months after treatment.
The company is also advancing a third study in the program, Emerald-2, a phase 3 trial evaluating Imfinzi in combination with Avastin as an adjuvant therapy for liver cancer. The study is expected to yield results in the second half of 2026.
Regarding the Imfinzi–Imjudo combination, AstraZeneca is also anticipating data readouts later this year from its Nile trial in first-line metastatic bladder cancer, as well as from the Volga study evaluating a neoadjuvant approach in patients with cisplatin-ineligible muscle-invasive disease. Both studies will be expected to match the strong benchmark set by the pairing of Merck & Co.’s Keytruda and the antibody-drug conjugate Padcev from Pfizer and Astellas Pharma
What Are Imfinzi and Imjudo?
Imfinzi is an immunotherapy drug (durvalumab) that works by blocking the PD-L1 protein, helping the immune system detect and attack cancer cells. Imfinzi is widely used across multiple cancer types and continues to expand its clinical footprint.
Imjudo (tremelimumab) is another immunotherapy agent targeting CTLA-4, and when combined with Imfinzi, the dual mechanism enhances immune response against tumors.
Clinical Trial Results for Imfinzi Combination
The Imfinzi and Imjudo combination has shown strong results in patients with unresectable hepatocellular carcinoma (HCC), the most common form of liver cancer.
Impact on AstraZeneca’s Oncology Strategy
The success of Imfinzi reinforces AstraZeneca’s leadership in immuno-oncology. Imfinzi continues to be a cornerstone of the company’s cancer portfolio, with ongoing trials exploring new combinations and indications.
This milestone further validates AstraZeneca’s investment in immune-based therapies, positioning Imfinzi as a key growth driver.
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