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news.Japan-based pharmaceutical firm Eisai has released results of its Phase III SELECT trial (Study 303) of lenvatinib, an investigational selective tyrosine kinase inhibitor (TKI) with a novel binding mode, which showed that the trial met its primary endpoint.
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When compared to placebo, lenvatinib showed statistically significant improvement in progression free survival (PFS) in patients with radioiodine-refractory differentiated thyroid cancer (RR-DTC).
According to the preliminary safety analysis, five most common adverse reactions were hypertension, diarrhea, decreased appetite, decreased weight, and nausea.
Based on the results of the multicenter, randomized, double-blind, placebo-controlled SELECT (Study of E7080 LEnvatinib in Differentiated Cancer of the Thyroid) trial, the company intends to file marketing authorization applications for lenvatinib to health authorities in the US, Japan, and Europe.
The trial was designed 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 (24mg) versus placebo.
The secondary endpoints of the trial included overall response rate (ORR), overall survival (OS), and safety.
About 392 patients were enrolled in the trial, which was carried out at over 100 sites in Europe, North and South America, and Asia by Eisai in collaboration with the SFJ Pharmaceuticals Group.
Eisai Product Creation Systems president of Oncology Product Creation Unit Kenichi Nomoto said the results show the potential role of the investigational drug lenvatinib in this rare, hard-to-treat cancer.
"RR-DTC remains an unmet need with a limited number of treatment options," Nomoto said.
Lenvatinib, discovered and developed by Eisai, secured orphan drug designation (ODD) in Japan for thyroid cancer; in the US for follicular, medullary, anaplastic, and metastatic or locally advanced papillary thyroid cancer; and in Europe for follicular and papillary thyroid cancer.
The company’s ongoing global clinical trial program includes Phase III and Phase II studies in several other tumor types.
The drug is currently under investigation as a potential treatment for thyroid, hepatocellular, endometrial and other solid tumor types.
Image: Eisai head office in Tokyo, Japan. Photo: courtesy of Arthena