Merck and Eisai's Phase III LEAP-002 trial disappoints in uHCC

US pharma giant Merck & Co (NYSE: MRK) and Japan’s Eisai (TYO: 4523) today announced that the Phase III LEAP-002 trial investigating Keytruda (pembrolizumab), Merck’s anti-PD-1 therapy, plus Lenvima (lenvatinib), the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai, versus Lenvima monotherapy did not meet its dual primary endpoints of overall survival (OS) and progression-free survival (PFS) as a first-line treatment for patients with unresectable hepatocellular carcinoma (uHCC).

There were trends toward improvement in OS and PFS for patients who received Keytruda plus Lenvima plus versus Lenvima monotherapy; however, these results did not meet statistical significance per the pre-specified statistical plan. The median OS of the Lenvima monotherapy arm in LEAP-002 was longer than that observed in previously reported clinical trials evaluating Lenvima monotherapy in uHCC. The safety profile of Keytruda plus Lenvima was consistent with previously reported data on the combination. Merck and Eisai plan to present these data at an upcoming medical conference.

Will continue to investigate role across multiple types of cancer