TOKYO : Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today that its U.K. subsidiary Eisai Europe Ltd. has received approval from the European Commission (EC) for anticancer agent Lenvima (lenvatinib mesylate) in the treatment of adult patients with progressive, locally advanced or metastatic differentiated (papillary, follicular, Hurthle cell) thyroid carcinoma (DTC), refractory to radioactive iodine (RAI). Lenvima was granted an accelerated assessment by the European Medicines Agency, and was ultimately approved in approximately 9 months since the application was filed on August 14, 2014.

The decision by the EC was based on the results of a multicenter, randomized, double-blind, placebo-controlled Phase III study (the SELECT study) on progressive RAI refractory DTC(1). In the study’s primary endpoint of progression-free survival (PFS), Lenvima demonstrated a statistically significant extension in PFS compared to placebo (p<0.001; median PFS in the Lenvima group: 18.3 months, median PFS in the placebo group: 3.6 months; Hazard Ratio (HR) 0.21 [99% CI: 0.14-0.31]). In addition, the study underlines the rapid response of Lenvima, with a median time to first objective response of 2.0 months.

Furthermore, Lenvima demonstrated a statistically significant improvement in objective response rate (number of objective responders [%]) compared to placebo (p<0.001; Lenvima: 64.8% vs placebo: 1.5%). In particular, complete response was observed in 1.5% (4 patients) of the Lenvima group and none in the placebo group.

The most common Lenvima treatment-related adverse events were hypertension, diarrhea, fatigue or asthenia, decreased appetite, weight loss and nausea.

Discovered at Eisai’s Tsukuba Research Laboratories and developed in-house, Lenvima is an orally administered molecular targeted agent that selectively inhibits the activities of several different molecules including VEGFR, FGFR, RET, KIT and PDGFR. In particular, the agent simultaneously inhibits VEGFR, FGFR and RET, which are especially involved in tumor angiogenesis and proliferation of thyroid cancer.

Furthermore, Lenvima has been confirmed through X-ray co-crystal structural analysis to demonstrate a new binding mode (Type V) to VEGFR2, and exhibits potent inhibition of kinase activity and rapid binding to the target molecule according to kinetic analysis(2).

Lenvima was launched in the United States indicated for the treatment of locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer in February 2015. In addition, Lenvima was approved in Japan for the treatment of unresectable thyroid cancer in March 2015.

Thyroid cancer affects more than 52,000 people in Europe each year. Although treatment is possible for most types of thyroid cancer, there are few treatment options available once thyroid cancer has progressed, therefore it remains a disease with significant unmet medical needs. Eisai is committed to exploring the potential clinical benefits of Lenvima in order to further contribute to patients with cancer and their families.