Amarin Highlights EMT2 Phase 3 Results: Icosapent Ethyl Misses PFS, Improves Overall Survival

Amarin Corporation plc said the University of Leeds-sponsored Phase 3 EMT2 trial of VAZKEPA/VASCEPA (icosapent ethyl) did not meet its primary progression-free survival endpoint but showed improved overall survival in patients undergoing liver resection for colorectal cancer liver metastases. The results were presented as a late breaker at the European Society for Medical Oncology 2026 Congress in Madrid, GlobeNewswire reported on October 25, 2026.

How the EMT2 Trial Was Designed

EMT2 was a randomized, double-blind, placebo-controlled, multi-center Phase 3 investigator-initiated trial sponsored by the University of Leeds and funded by Yorkshire Cancer Research. It enrolled 418 patients across 13 hepatobiliary surgery centers in England and Wales between 2018 and 2023. Patients were randomized 1:1 to highly purified prescription EPA ethyl ester 4 g/day or matched mineral oil placebo, with treatment initiated before surgery and continued for up to four years. Amarin supplied the investigational product free of charge.

Median progression-free survival was 13.5 months with icosapent ethyl versus 12.9 months with placebo, with an adjusted hazard ratio of 0.89 and a p-value of 0.329. The five-year overall survival estimate was 62.0% with icosapent ethyl versus 45.1% with placebo, corresponding to an approximately 32% reduction in the risk of death, with an adjusted hazard ratio of 0.68 and a p-value of 0.030. Icosapent ethyl was reported to be safe and well tolerated, with no excess of total adverse events, bleeding episodes, atrial fibrillation, or deterioration in quality of life.

"An overall survival benefit without a corresponding progression-free survival benefit is not an unprecedented finding in oncology," said Professor Mark A. Hull, Chief Investigator at the University of Leeds. "This type of oncology endpoint pattern can be observed where delayed effects on host anti-tumor immunity may influence long-term outcomes."

Amarin's Financial Position

Amarin is an Ireland-domiciled biopharmaceutical company that develops and commercializes VASCEPA/VAZKEPA (icosapent ethyl), sold via direct U.S. sales and partner networks across approximately 100 global markets, according to akta.pro company records. The company reported $45.1 million in total net revenue for the first quarter of 2026, up 7% year-over-year from $42.0 million in the first quarter of 2025. Cash and investments stood at $307.8 million as of March 31, 2026, up from $281.8 million year-over-year, and the company is debt-free. Amarin achieved its second consecutive quarter of positive cash flow in the first quarter of 2026 at $6.4 million.

Earlier Amarin Research and Earnings

Amarin presented a post hoc analysis of the REDUCE-IT trial at the European Society of Cardiology Congress 2026 in Munich, finding that highly adherent patients on icosapent ethyl for at least 1.5 years saw about a 30% relative risk reduction in major adverse cardiovascular events, Stock Titan reported in August 2026. The company announced in August 2026 that it would present five new analyses derived from the REDUCE-IT trial and related mechanistic data at the same congress. In July 2026, Amarin reported that VASCEPA achieved a 48% market share and experienced a 69% increase in European demand during the second quarter of 2026.

What Comes Next for Amarin

Amarin will report its third quarter 2026 financial results and host a conference call on October 28, 2026, issuing a press release in pre-market hours followed by the call at 8:00 a.m. ET. The company said its team will continue to collaborate with the study sponsor to better understand the EMT2 results and develop a clearer perspective on the potential opportunity.