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Merck : Phase 3 Trial Of Keytruda Combination In Liver Cancer Fails To Meet Main Goal

Merck & Co Inc. (MRK) and Eisai said that the phase 3 LEAP-002 trial investigating Merck's anti-PD-1 therapy Keytruda plus Lenvima, the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai, versus Lenvima monotherapy did not meet its dual primary endpoints of overall survival and progression-free survival as a first-line treatment for patients with unresectable hepatocellular carcinoma.

Hepatocellular carcinoma is the most common type of primary liver cancer and the most rapidly increasing cause of cancer deaths in the United States.

There were trends toward improvement in overall survival and progression-free survival for patients who received Keytruda plus Lenvima versus Lenvima monotherapy; however, these results did not meet statistical significance per the pre-specified statistical plan. The median overall survival of the Lenvima monotherapy arm in LEAP-002 was longer than that observed in previously reported clinical trials evaluating Lenvima monotherapy in unresectable hepatocellular carcinoma.

The safety profile of Keytruda plus Lenvima was consistent with previously reported data on the combination.

Lenvima monotherapy is approved for the first-line treatment of patients with unresectable hepatocellular carcinoma in the U.S., Europe, and China, and for patients with unresectable hepatocellular carcinoma in Japan.

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