On January 25, 2017 Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") reported that a Phase III clinical trial (Study 304) of its in-house discovered and developed anticancer agent Lenvima (lenvatinib mesylate, "lenvatinib") against the comparator sorafenib as a first-line treatment for patients with unresectable hepatocellular carcinoma has achieved its primary endpoint (Press release, Eisai, JAN 25, 2017, View Source [SID1234517544]). Schedule your 30 min Free 1stOncology Demo! Study 304 is a multicenter, randomized, open-label, global Phase III study comparing the efficacy and safety of lenvatinib versus sorafenib, a standard treatment for advanced hepatocellular carcinoma, as a first-line treatment for patients with unresectable hepatocellular carcinoma. In the study, 954 patients were randomized in a 1:1 ratio to receive lenvatinib 12 mg or 8 mg once a day, depending on baseline body weight (n= 478) or sorafenib 400 mg twice a day (n= 476). Treatment was continued until disease progression or unacceptable toxicity.
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The primary endpoint of the study was overall survival (OS), with the goal of demonstrating non-inferiority. Other factors including progression free survival (PFS), time to progression (TTP) and objective response rate (ORR) were assessed as secondary endpoints.
According to the results of the study, lenvatinib met the statistical criteria for non-inferiority of OS compared to sorafenib, and showed statistically significant and clinically meaningful improvement for PFS, TTP and ORR. 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 PK parameters as well as safety are ongoing.
Eisai plans to hold discussions with regulatory authorities for submission in Japan, the United States, Europe and Asia, including China. Eisai will also present the details at an upcoming academic conference.
Liver cancer is the second leading cause of cancer related deaths, and is estimated to be responsible for approximately 700,000 deaths per year in the world1. The majority of cases occur in Asia, including China, and Africa. Hepatocellular carcinoma accounts for 85% to 90% of primary liver cancer cases. Early stage hepatocellular carcinoma is treatable by a wide variety of means, including surgery, radiofrequency ablation, ethanol injection, chemoembolization therapy, but treatment opinions for unresectable hepatocellular carcinoma are limited and the prognosis is very poor, meaning that this is an area of high unmet medical need.
Eisai positions oncology as a key therapeutic area, and is aiming to discover revolutionary new medicines with the potential to cure cancer. Eisai remains committed to providing further clinical evidence for lenvatinib aimed at maximizing value of the drug as it seeks to contribute further to addressing the diverse needs of, and increasing the benefits provided to, patients with cancer, their families, and healthcare providers.