Eisai has reported positive results from analysis of the subpopulation of subjects in the Greater China region participating in its Phase III REFLECT clinical trial of lenvatinib mesylate (Lenvima) to treat unresectable hepatocellular carcinoma (HCC).

Discovered and developed by the firm, lenvatinib is an oral inhibitor of multiple receptor tyrosine kinase (RTK) being developed to selectively inhibit the kinase activities of vascular endothelial growth factor (VEGF) receptors and fibroblast growth factor (FGF) receptors.

Based on an extension of overall survival (OS) in the subpopulation, lenvatinib was found to be effective when compared with sorafenib as a first-line treatment in the REFLECT trial.

The drug candidate further demonstrated improvements in progression-free survival (PFS), time to progression (TTP) and objective response rate (ORR).

REFLECT’s Greater China subpopulation included 288 patients out of the total 954 subjects participating in the trial.

“The drug candidate further demonstrated improvements in progression-free survival, time to progression and objective response rate.”

It was observed that for 80% of these patients whose HCC was due to chronic hepatitis B virus infection, their median OS using lenvatinib was 14.9 months compared with 9.9 months with sorafenib.

The results indicated that the safety profile for the subpopulation was consistent with that of its previous studies.

Lenvatinib is currently approved for the treatment of refractory thyroid cancer in more than 50 countries such as the US and Japan, in addition to Europe.

As a combination therapy with everolimus, the drug candidate is approved as a second-line treatment for renal cell carcinoma various countries.

The firm is also conducting a Phase Ib trial with lenvatinib for HCC, along with a Phase Ib/II trial with pembrolizumab combination for certain solid tumours.