Eisai, Merck & Co. bag EU approval for Lenvima in unresectable HCC, days after US nod

Eisai and Merck & Co. reported Thursday that the European Commission approved Lenvima (lenvatinib) as a single agent for the first-line treatment of adults with advanced or unresectable hepatocellular carcinoma (HCC) who have received no prior systemic therapy. Last week, the FDA authorised the oral receptor tyrosine kinase inhibitor in the same indication.

According to Eisai and Merck, Lenvima "is the first new first-line treatment option for advanced or unresectable HCC to be approved in Europe in approximately 10 years."

Approval was backed by data from the Phase III REFLECT study of 954 patients with previously untreated, unresectable HCC. Results demonstrated that Lenvima was non-inferior, but not statistically superior to Bayer's Nexavar (sorafenib) on the primary endpoint of overall survival (OS), with patients achieving a median OS of 13.6 months and 12.3 months, respectively. Further, Lenvima was associated with significant improvement in progression-free survival at 7.3 months, compared with 3.6 months for Nexavar, while the objective response rate was also significantly improved, at 41 percent for Lenvima versus 12 percent for Nexavar-treated patients.

The European Commission previously approved Lenvima for use in adults with progressive, locally advanced or metastatic differentiated thyroid carcinoma that is refractory to radioactive iodine.

Under the terms of a deal forged in March, Merck and Eisai agreed to jointly develop and market Lenvima for multiple cancer types, both as monotherapy and in combination with Merck's anti-PD-1 therapy Keytruda (pembrolizumab).

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