Eisai Co., Ltd. announced 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. 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 epatocellular 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.