09:10 AM EDT, 10/29/2025 (MT Newswires) -- Merck ( MRK ) and Eisai said Wednesday the phase 3 Leap-012 trial assessing Keytruda and Lenvima with transarterial chemoembolization, or TACE, in patients with unresectable, non-metastatic hepatocellular carcinoma did not meet "statistical significance" for its primary endpoint of improving overall survival compared with TACE alone.

The companies said they decided to close the study after determining that the likelihood of reaching statistical significance for overall survival at a future analysis was low.

The combination had previously met its other main endpoint, showing a significant improvement in progression-free survival, the companies said.

Merck ( MRK ) and Eisai said the results of the study do not affect existing approvals for the Keytruda and Lenvima combination, including their approved use with TACE in China for unresectable non-metastatic hepatocellular carcinoma.