E 7080 meets primary endpoint in Phase III trial for Thyroid Cancer-Eisai
The Phase III SELECT trial (Study 303) of E 7080 (lenvatinib), from Eisai, has met its primary endpoint in patients with radioiodine-refractory differentiated Thyroid Cancer (RR-DTC). Compared to placebo, lenvatinib showed a highly statistically significant improvement in progression free survival. Secondary endpoints of the study included overall response rate, overall survival, and safety.
The study enrolled 392 patients at over 100 sites in Europe, North and South America and Asia. The preliminary safety analyses 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 the United States, Japan, and Europe.