Phase III trial of Lenvima (lenvatinib) meets primary endpoint in hepatocellular carcinoma- Eisai

Eisai announced positive topline results from the randomized, multicenter Phase III trial (Study 304) evaluating the company's multiple receptor tyrosine kinase inhibitor, Lenvima (lenvatinib) for the first-line treatment of patients with unresectable hepatocellular carcinoma (HCC). The trial achieved its primary endpoint by meeting the statistical criteria for non-inferiority of overall survival with lenvatinib compared to sorafenib, the current standard of care for systemic treatment in this setting.

Eisai plans to present the results of this study at an upcoming medical meeting and discuss these data with regulatory authorities in the United States and worldwide. Clinically meaningful and statistically significant improvements for lenvatinib were achieved in progression-free survival, time to progression and objective response rate, the secondary efficacy endpoints. In this study, the five most common adverse events observed in the lenvatinib arm were hypertension, diarrhea, decreased appetite, weight loss, and fatigue, which is consistent with the known side-effect profile of lenvatinib. Analyses of the remaining secondary endpoints of quality of life and plasma pharmacokinetics parameters, as well as safety, are ongoing.