Health
Merck and Eisai Provide Update on Phase 3 LEAP-012 Trial in Unresectable, Non-Metastatic Hepatocellular Carcinoma
RAHWAY, N.J. & NUTLEY, N.J., October 29, 2025--Merck and Eisai Provide Update on Phase 3 LEAP-012 Trial in Unresectable, Non-Metastatic Hepatocellular Carcinoma
About this update from Eisai Co., Ltd.
[{"type":"image","alt":"","displaySize":"","headline":null,"caption":"","credit":null,"className":"","disableSlideshowImg":false,"size":{"original":{"width":480,"height":217,"url":"https://media.zenfs.com/en/business-wire.com/910de16fd9da24bc23a005bc635efa6c"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/1iSRSuubhwPMFwgxAY51lw--/YXBwaWQ9aGlnaGxhbmRlcjt3PTk2MDtoPTQzNDtjZj13ZWJw/https://media.zenfs.com/en/business-wire.com/910de16fd9da24bc23a005bc635efa6c","width":480,"height":217}},"lazy":false},{"type":"image","alt":"","displaySize":"","headline":null,"caption":"","credit":null,"className":"","disableSlideshowImg":false,"size":{"original":{"width":480,"height":324,"url":"https://media.zenfs.com/en/business-wire.com/6c172fd740ada8aa87c765454ac2929d"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/zknHVXaejgW6NS.pEhyFEA--/YXBwaWQ9aGlnaGxhbmRlcjt3PTk2MDtoPTY0ODtjZj13ZWJw/https://media.zenfs.com/en/business-wire.com/6c172fd740ada8aa87c765454ac2929d","width":480,"height":324}}},{"type":"text","content":"RAHWAY, N.J. & NUTLEY, N.J., October 29, 2025--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside of the United States and Canada, and Eisai today announced results from the Phase 3 LEAP-012 trial evaluating KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, plus LENVIMA® (lenvatinib), the orally available multiple receptor tyrosine kinase inhibitor (TKI) discovered by Eisai, in combination with transarterial chemoembolization (TACE) for the treatment of patients with unresectable, non-metastatic hepatocellular carcinoma (HCC).","length":546,"tagName":"p"},{"type":"text","content":"At a pre-specified interim analysis, KEYTRUDA plus LENVIMA in combination with TACE did not achieve statistical significance for overall survival (OS), one of the study’s primary endpoints, compared to TACE alone. The likelihood of reaching the protocol-specified threshold for statistical significance for OS at a future analysis was evaluated by Merck and Eisai and considered to be low. On this basis, the study will be closed, and the companies are informing investigators of this decision. The safety profile of the KEYTRUDA plus LENVIMA-based regimen was consistent with that observed in previously reported studies evaluating the combination and in earlier analyses of LEAP-012. Further analysis of the data is ongoing; Merck and Eisai will work with investigato...