418 Patients in Vascepa Trial That Missed Primary Goal Showed Overall Survival Benefit
Key Facts
Amarin announced on October 25, 2026, results from the Phase III EMT2 trial of Vascepa in patients with colorectal cancer that had spread to the liver. The trial failed to meet its primary endpoint of improving progression-free survival, according to the company’s disclosure. By contrast, an analysis of estimated five-year overall survival showed a statistically significant benefit, according to the same statement. The result points in two different directions: the primary endpoint was not met, while a positive signal emerged on a key secondary endpoint. The study tested adding icosapent ethyl to usual treatment, not an approved use for cancer treatment.
The trial enrolled 418 patients and was described by ClinicalTrials.gov as a randomized, double-blind, multicenter, placebo-controlled study. It began on May 2, 2018, and its estimated completion date was April 30, 2026. Recruitment closed on November 30, 2023, according to the University of Leeds Clinical Trials Research Unit page. Participants received four capsules daily of icosapent ethyl, equivalent to 4 grams per day of icosapent ethyl ester, or four placebo capsules. Progression-free survival was the primary endpoint, while overall survival was a key secondary endpoint.
The University of Leeds sponsored the trial, which was funded by Yorkshire Cancer Research, according to Amarin’s disclosure. The study examined the experimental use of icosapent ethyl after resection of colorectal cancer metastases from the liver, adding it to usual care. This research differs from Vascepa’s approved indication: the European Medicines Agency says its approved use is intended to reduce cardiovascular risk in specific groups. The overall survival signal therefore does not mean the drug is approved to treat cancer or that its effectiveness for this purpose has been established. AMRN shares closed at $11.79 on October 23, according to L7 data.
The University of Leeds trial page had previously said results were expected in 2026, after recruitment closed, but stated when the page was written that results had not yet been assessed. The ClinicalTrials.gov record lists the study design, endpoints and participant details, but does not include published results. The results announced on October 25 are based here on the company’s disclosure about a university-sponsored trial. The contrast between missing the primary endpoint and the positive secondary result remains central to interpreting the announced data. The information provided did not specify a later date for presenting the results or taking a regulatory step regarding their use in oncology.