US, EU filings for Eisai’s lenvatinib in liver cancer

Lenvatinib is an orally administered multiple receptor tyrosine kinase (RTK) inhibitor with a novel binding mode already on certain global markets as a treatment for thyroid cancer, under the brand name Lenvima, and for renal cell cancer, under the brand name Kisplyx (in the EU).

The company has now submitted filings in the US and EU requesting permission to market the therapy for hepatocellular carcinoma (HCC), the second leading cause of cancer related death.

Treatment options for unresectable HCC are limited and the prognosis is very poor, making this an area of high unmet medical need, highlighting the urgent need for new therapeutic options especially as there haven’t been any advances in first-line systemic treatment in a decade.

In the REFLECT study, lenvatinib showed an overall survival treatment effect with non-inferiority compared to Bayer’s Nexavar (sorafenib), which is particularly noteworthy given that, over the last decade, four previous first-line Phase III studies pitting other agents against sorafenib have failed to achieve this endpoint in OS, said Eisai.

The drug also hit key secondary targets improving progression free survival (PFS), time to progression (TTP), and objective response rate (ORR), while the five most common adverse events observed in the trial were hypertension, diarrhoea, decreased appetite, weight loss and fatigue.