Amarin Reports EMT2 Trial Survival Benefit With Icosapent Ethyl

DUBLIN AND BRIDGEWATER, N.J. — October 25, 2026

EMT2 Evaluates Icosapent Ethyl Following Liver Resection

The EMT2 study (ClinicalTrials.gov identifier NCT03428477) enrolled 418 patients across 13 hepatobiliary surgery centers in England and Wales between 2018 and 2023. Participants undergoing liver resection for CRCLM were randomized in a 1:1 ratio to receive highly purified prescription eicosapentaenoic acid (EPA) ethyl ester at 4 g per day or a matched mineral-oil placebo. Treatment began before surgery and continued for up to four years. The trial was funded by Yorkshire Cancer Research and sponsored by the University of Leeds, with participation from Leeds Teaching Hospitals NHS Trust and researchers at the universities of Bradford, Liverpool and Edinburgh. Amarin supplied the investigational product without charge. PFS was the primary endpoint, while OS was a key secondary endpoint for which the trial was prespecified and statistically powered. The PFS results showed only a small numerical difference between treatment groups: 13.5 months with IPE compared with 12.9 months with placebo. The adjusted HR of 0.89 had a 95% CI that crossed 1.0, and the p-value of 0.329 indicated that the primary endpoint was not statistically significant. The OS analysis, however, favored IPE. The estimated five-year survival rate was 62.0%, compared with 45.1% in the placebo group, with an adjusted HR of 0.68 and p=0.030. This corresponds to an approximately 32% relative reduction in the risk of death, rather than a 32-percentage-point increase in survival. The difference between the PFS and OS findings is an important feature of the trial. It does not demonstrate that IPE prevents cancer progression, and the mechanism underlying the reported survival difference has not been established. The findings instead raise questions about whether the treatment may influence outcomes through biological effects not captured by the primary PFS endpoint. Further analyses and independent scientific assessment will be important in determining the robustness and clinical interpretation of the results.

Safety Profile and Potential Biological Mechanisms

Investigators reported that prescription IPE was well tolerated throughout EMT2. There was no reported excess in total or serious adverse events, bleeding episodes, atrial fibrillation or clinically meaningful quality-of-life deterioration relative to placebo. Serious bleeding events requiring transfusion or re-operation were numerically lower in the IPE group. The safety findings were described as consistent with the known safety profile of prescription IPE. These results are relevant because patients undergoing liver surgery may face additional clinical considerations when receiving adjunctive therapies. Nevertheless, the reported trial findings should not be interpreted as eliminating established safety risks associated with IPE in other populations or settings. Amarin’s U.S. prescribing information includes warnings regarding atrial fibrillation or atrial flutter requiring hospitalization and increased bleeding risk, particularly in patients receiving concomitant antithrombotic medication. The investigators proposed several possible explanations for the observed OS benefit despite the absence of a significant PFS improvement. These include potential anti-inflammatory or antineoplastic effects and possible enhancement of host antitumor immune surveillance through changes in the gut microbiome. Published research has also examined EPA incorporation into colorectal tissue following IPE administration. However, these mechanisms remain hypotheses rather than demonstrated explanations for the EMT2 survival findings. Additional analyses of the trial dataset and further studies will be needed to assess whether any of these pathways contributed to the observed outcome. Colorectal cancer remains a major cause of cancer-related mortality worldwide. Liver metastases occur in a substantial proportion of patients, and recurrence and mortality remain important concerns even after surgery intended to remove metastatic disease and contemporary multimodality treatment. The EMT2 findings therefore provide a basis for further investigation into potential adjunctive approaches, but they do not yet establish IPE as a standard oncology treatment.

Amarin Plans Further Evaluation of EMT2 Findings

Amarin said it would continue collaborating with the University of Leeds study sponsor to better understand the findings and assess the potential implications for patients undergoing liver resection for CRCLM. Professor Mark Hull, EMT2 chief investigator at the University of Leeds, noted that an OS benefit without a corresponding PFS benefit has been observed in oncology research and may warrant investigation into delayed biological effects. Amarin’s research leadership described the survival result as clinically important and deserving of further scientific evaluation. The company also highlighted the potential relevance of prescription IPE’s biological effects beyond cardiovascular disease, while acknowledging the need to develop a clearer understanding of the opportunity. IPE is the active ingredient in VASCEPA in the United States and VAZKEPA in Europe, where the products are approved for specified cardiovascular indications. The EMT2 results do not constitute regulatory approval for cancer treatment, and the current evidence does not establish IPE as an effective therapy for preventing progression of colorectal cancer liver metastases. The study’s primary endpoint was not met, and further review of the OS findings, the full dataset and potential biological mechanisms will be important before drawing conclusions about clinical adoption. The results add to the evidence base for investigating high-purity prescription EPA in patients with significant unmet medical needs, while leaving open key questions about the reproducibility, mechanism and appropriate clinical use of the reported survival benefit.

Source:Amarin Corporation ,Press release