Eisai asserts positive results of Phase 3 Study for lenvatinib mesylate

Eisai declared positive results of Phase 3 study for its discovered and developed anticancer agent lenvatinib mesylate in patients grappling with unresectable hepatocellular carcinoma (HCC) as published in the online version of the Lancet.

The REFLECT study reported on in the paper was a multicenter, open-label, randomized, global Phase 3 study comparing the efficacy and safety of lenvatinib versus sorafenib, a standard treatment for advanced hepatocellular carcinoma, as a first-line treatment in patients with unresectable HCC. The IIR was conducted using both RECIST 1.1, which uses the traditional assessment of the effect on change in tumor diameter, and mRECIST, which takes into account areas of tumor necrosis in addition to the RECIST 1.1 criteria. Results of the IIR analyses were consistent with and corroborated those for the investigator assessments demonstrating an improvement in PFS and TTP,

Eisai submitted applications for lenvatinib for the treatment of HCC in Japan (June 2017), the United States and Europe (July 2017), China(October 2017), Taiwan (December 2017) and other countries. Eisai remains committed to providing additional clinical evidence for lenvatinib aimed at maximizing the value of the drug to patients.