AstraZeneca is polishing the case for its Imfinzi (durvalumab) and Imjudo (tremelimumab) combo in liver cancer with a new phase 3 readout from its Emerald trial program assessing the immunotherapy duo in a locoregional setting.
The phase 3 Emerald-3 study, presented June 1 at the Annual Society of Clinical Oncology (ASCO) 2026 annual meeting in Chicago, positions AZ’s Imfinzi/Imjudo regimen as a “compelling therapeutic option” for patients with unresectable embolization-eligible hepatocellular carcinoma (HCC), ASCO expert Vishwanath Sathyanarayanan, M.D., commented in an ASCO press release.
In the 760-patient, three-armed study, the company paired its PD-L1 antibody Imfinzi and its anti-CTLA-4 antibody Imjudo with Merck and Eisai’s Lenvima (lenvatinib) and transarterial chemoembolization (TACE), finding that the regimen provided statistically significant and clinically meaningful improvements in progression-free survival over TACE alone. The study design utilized AZ’s STRIDE dosing protocol, which primes patients with a single dose of Imjudo added to Imfinzi followed by Imfinzi every four weeks.
When combined with Lenvima and TACE, the STRIDE regimen demonstrated a 30% reduction in the risk of disease progression or death compared to TACE alone, with a median progression-free survival of 13 months over the 9.8 months seen in the solo TACE arm.
Those who are eligible for liver embolization are considered early stage and are typically treated with TACE, a standard-of-care minimally invasive procedure that delivers chemotherapy straight into the tumor's blood supply.
However, many patients experience disease progression locally following TACE, requiring repeated therapies, Sunil Verma, AZ’s SVP, global head oncology franchise told Fierce Pharma. And while newer innovations have sparked important survival improvements in advanced disease stages, this earlier-stage setting hasn’t seen “any shift and adoption of new systemic therapy for decades,” Verma said.
“This really gives us important evidence that STRIDE works across the continuum of patients and hepatoceullar carcinoma,” Verma explained. “We can now finally bring a benefit to patients with early-stage disease, where there hasn’t been an improvement for decades.”
A final overall survival result has not yet been reached, but researchers observed a “positive trend” favoring the STRIDE regimen and Lenvima, AZ reported in its June 1 press release.
The findings suggest a two-year overall survival rate of 66.9% versus 61.5% in the solo-TACE group, the ASCO release points out.
The other investigational arm of the study, measuring STRIDE and TACE’s benefits without Lenvima, showed a “clinically meaningful” improvement in progression-free survival over TACE alone. Although those endpoints were not formally tested at the time of analysis, median progression-free survival in that group was 12.9 months compared to the 8.1 months seen in the solo TACE arm.
“These findings are likely to influence clinical practice and may be considered practice-changing for medical oncologists treating hepatocellular carcinoma globally,” Sathyanarayanan added.
HCC is the most common type of liver cancer and represents more than 8 in 10 liver cancer diagnoses, according to ASCO. The disease is most commonly diagnosed at later stages, when surgery is no longer an option.
Imjudo might just be what Imfinzi needs to conquer the locoregional disease setting after the latter drug made some inroads in 2024’s Emerald-1 readout. That study paired Imfinzi with Roche’s Avastin and TACE, finding a 23% reduction in the risk of disease progression or death. Overall survival results had been immature at the time and still haven’t been assessed in the years since, as the company continues “waiting for more mature follow-up,” Verma confirmed.
Emerald-3, too, will continue on to formally assess overall survival and other secondary endpoints across both investigational arms. Still, based on the new data, AZ will “have discussions” with regulators across the globe on potential regulatory submissions, Verma said.
The overall survival follow-up will likely be key, as AstraZeneca oncology R&D chief Susan Galbraith, Ph.D., previously noted that patient survival data are crucial in the locoregional setting.
This point last year caused Merck and Eisai to scrap work on a Keytruda, Lenvima and TACE regimen after an overall survival miss in a similar indication. The result followed encouraging progression-free survival data that reflected a 34% decrease in the risk of disease progression or death, results that were presented at a “practice-changing trials” symposium session at the 2024 European Society of Medical Oncology (ESMO) meeting.
Nonetheless, Imjudo’s Imfinzi-partnered growth path represents a turnaround from some historical troubles for the drug. Its market debut in 2022 as a combo treatment for HCC came after a string of failures across multiple cancer types until it found its place in liver cancer with its novel STRIDE approach and positive data from AZ’s Himalaya study. Imjudo later won another approval for metastatic non-small cell lung cancer, also in combination with Imfinzi.
Imfinzi, meanwhile, has treated more than 414,000 patients since its market introduction in 2017 and serves as a cornerstone of AZ’s growing oncology portfolio. As a solid blockbuster sales earner for years now, the drug’s next wave of growth is slated to come from combination regimens such as its Imjudo pairing, the company noted in its 2025 full-year earnings presentation (PDF) in February. Imfinzi collected $6 billion in worldwide sales last year, growing 28% from 2024. Imjudo, for its part, flexed 23% growth to $346 million.