Key insights
- Amarin Corporation's Vascepa (icosapent ethyl) showed a statistically significant overall survival benefit in a Phase 3 trial for colorectal cancer liver metastases, though it missed its primary endpoint of progression-free survival. The drug was well-tolerated. While the PFS miss is a setback, the OS improvement suggests potential value, though further analysis is needed to understand the mechanism. This outcome could influence future treatment strategies and Amarin's market position.
Amarin Corporation (AMRN) reported results from the Phase 3 EPA for Metastasis Trial 2 (EMT2), a University of Leeds-sponsored study evaluating icosapent ethyl (IPE) in patients undergoing liver resection for colorectal cancer liver metastases (CRCLM). The findings were presented at the European Society for Medical Oncology 2026 Congress in Madrid.
The trial did not meet its primary endpoint of progression-free survival (PFS) in the intent-to-treat population. Median PFS was 13.5 months with IPE versus 12.9 months with placebo (adjusted HR 0.89; 95% CI 0.70–1.13; p=0.329).
The pre-specified key secondary endpoint of overall survival (OS) showed a statistically significant result. The five-year OS estimate was 62.0% with IPE versus 45.1% with placebo, representing an approximately 32% reduction in the risk of death (adjusted HR 0.68; 95% CI 0.48–0.96; p=0.030).
IPE was reported to be well tolerated, with no excess of total adverse events, bleeding episodes, atrial fibrillation, or deterioration in quality of life compared to placebo. Serious bleeding events requiring transfusion or re-operation were numerically lower in the IPE arm.
The randomized, double-blind, placebo-controlled trial enrolled 418 patients across 13 hepatobiliary surgery centers in England and Wales between 2018 and 2023. Patients were randomized 1:1 to 4 g/day of prescription IPE or matched mineral oil placebo, with treatment initiated before surgery and continued for up to four years. The trial was funded by Yorkshire Cancer Research, with investigational product supplied by Amarin free of charge.
Chief Investigator Professor Mark Hull said the overall survival benefit without a corresponding PFS benefit is not unprecedented in oncology, and that potential mechanisms, including anti-inflammatory activity and effects on gut microbiome, "remain investigational and require further analyses."
Amarin stated it will collaborate with the study sponsor to evaluate the results and assess potential next steps. The company noted that patent protection for Vazkepa/Vascepa in Europe extends through 2039.
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