AstraZeneca is refining the rationale for Imfinzi (durvalumab) and Imjud (tremelimumab) combination therapy in liver cancer, announcing new Phase 3 results from the Emerald trial program evaluating the immunotherapy duo in a locoregional setting.
The Phase 3 Emerald 3 study, presented June 1 at the 2026 Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, positions AZ’s Imfinzi/Imjud therapy as an “attractive treatment option” for patients with unresectable embolization-eligible hepatocellular carcinoma (HCC), ASCO expert Vishwanath Satyanarayanan, MD, commented in an ASCO press release.
In a three-arm study of 760 patients, the company combined its PD-L1 antibody Imfinzi and anti-CTLA-4 antibody Imjud with Merck and Eisai’s Lenvima (lenvatinib) and transarterial chemoembolization (TACE) and found that the regimen resulted in statistically significant and clinically meaningful improvements in progression-free survival compared to TACE alone. This study design utilized AZ’s STRIDE dosing protocol. In this protocol, patients are primed by adding Imjud to Imfinzi once and then adding Imjud every 4 weeks thereafter.
When combined with LENVIMA and TACE, the STRIDE regimen demonstrated a 30% lower risk of disease progression or death compared to TACE alone, with median progression-free survival of 13 months versus 9.8 months for TACE alone.
Patients who are candidates for hepatic embolization are considered early-stage and are usually treated with TACE, a minimally invasive standard treatment that administers chemotherapy directly into the tumor’s blood supply.
However, many patients develop local disease progression after TACE and require repeat treatments, Sunil Verma, SVP, Global Oncology Franchise Head, Arizona, told Fierce Pharma. And while new technological innovations have led to important survival improvements in advanced disease stages, this early-stage setting “has not seen a transition or introduction of new systemic therapies for decades,” Verma said.
“This really provides important evidence that STRIDE works across a range of patients and hepatocellular carcinoma,” Verma explained. “We can finally benefit patients with early-stage disease who have not seen improvement for decades.”
Although final overall survival results are not yet available, researchers observed “positive trends” favoring the STRIDE regimen, Lenvima, Arizona, reported in a June 1 press release.
The results suggest a two-year overall survival rate of 66.9% compared to 61.5% in the TACE alone arm, the ASCO release noted.
The other arm of the study measured the benefits of STRIDE and TACE without Lenvima and found a “clinically meaningful” improvement in progression-free survival compared to TACE alone. Although these endpoints had not been formally tested at the time of the analysis, median progression-free survival in that group was 12.9 months, compared with 8.1 months in the TACE alone group.
“These findings are likely to impact clinical practice and could be seen as practice-changing for medical oncologists treating hepatocellular carcinoma globally,” added Satyanarayanan.
According to ASCO, HCC is the most common type of liver cancer, accounting for more than 8 out of 10 liver cancer diagnoses. The disease is most commonly diagnosed at a later stage after surgery is no longer an option.
Imjuno may be exactly what Imfinzi needs to overcome the locoregional disease landscape after making some inroads with the announcement of Emerald 1 in 2024. The study found that Imfinzi combined with Roche’s Avastin and TACE reduced the risk of disease progression or death by 23%. Verma acknowledged that the overall survival results were still immature at the time and have not been evaluated for years since then as the company is “waiting for more mature follow-up.”
Emerald-3 will continue to formally evaluate overall survival and other secondary endpoints across both study arms. Still, AZ will “discuss” potential regulatory filings with regulators around the world based on the new data, Verma said.
Overall survival follow-up is likely to be key, as Dr. Susan Galbraith, AstraZeneca’s head of oncology research and development, has previously stated that patient survival data is important in the locoregional setting.
This point last year led Merck and Eisai to halt work on the Keytruda, Lenvima, and TACE regimens after missing overall survival in similar indications. The results followed encouraging data on progression-free survival, reflecting a 34% reduction in the risk of disease progression or death, presented at the 2024 European Society of Medical Oncology (ESMO) Congress’ Clinical Trials Changing Healthcare symposium session.
Nevertheless, Imjuno’s growth trajectory in partnership with Imfinzi represents a turnaround from some of the drug’s historical problems. Debuting in 2022 as a combination treatment for HCC, the company has gone through a series of failures in multiple cancer types to establish itself in liver cancer with its novel STRIDE approach and positive data from AZ’s Himalayan study. Imjuno subsequently received new approval for metastatic non-small cell lung cancer, also in combination with Imfinzi.
Meanwhile, Imfinzi has treated more than 414,000 patients since its market introduction in 2017 and serves as a cornerstone of AZ’s growing oncology portfolio. After years of solid blockbuster sales, the drug’s next wave of growth is expected to come from combination therapies, such as the Imjudo combination, the company said in its 2025 full-year earnings call (PDF) in February. Imfinzi had global sales of $6 billion last year, a 28% increase from 2024. For Imjuno, growth was down 23% to $346 million.
