Phase III Trial Shows Lenvatinib Meets Primary Endpoint of PFS Benefit in RR-DTC Treatment

Eisai Co., Ltd. has announced that the Phase III SELECT trial (Study 303) of lenvatinib, an investigational selective tyrosine kinase inhibitor (TKI) with a novel binding mode, the first-in-class of its kind, met its primary endpoint.

Compared to placebo, lenvatinib showed a highly statistically significant improvement in progression free survival (PFS) in patients with radioiodine-refractory differentiated thyroid cancer (RR-DTC).

The SELECT (Study of (E7080) LEnvatinib in differentiated Cancer of the Thyroid) study was a multicenter, randomized, double-blind, placebo-controlled Phase III study to compare the PFS of patients with RR-DTC and radiographic evidence of disease progression within the prior 12 months, treated with once-daily, oral lenvatinib (24 mg) versus placebo.

Secondary endpoints of the study included overall response rate (ORR), overall survival (OS) and safety. The study enrolled 392 patients at over 100 sites in Europe, North and South America and Asia and was conducted by Eisai in collaboration with the SFJ Pharmaceuticals Group.

The preliminary safety analysis showed that the five most common adverse reactions were hypertension, diarrhea, decreased appetite, decreased weight and nausea.

Based on these clinical results, Eisai will submit marketing authorization applications for lenvatinib to health authorities in Japan, the United States and Europe. If approved, lenvatinib will be the first molecular-targeted small molecule agent developed by a Japanese pharmaceutical company.

Thyroid cancer is the most common endocrine malignancy and global figures show that its incidence has significantly increased over the last 50 years. RR-DTC, a life-threatening form of the disease, has a significant unmet treatment need. Lenvatinib, discovered and developed by Eisai, was granted Orphan Drug Designation (ODD) in Japan, the United States and Europe.

Eisai has also initiated a global Phase III trial of lenvatinib in hepatocellular carcinoma (HCC) and is conducting Phase II studies of lenvatinib in several other tumor types.

Eisai is committed to understanding the potential clinical benefits of lenvatinib in order to further contribute to patients with cancer, including patients with thyroid cancer, and their families.