Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today that the results of a Phase III trial (Study 304) of its in-house discovered and developed anticancer agent lenvatinib mesylate (product names: Lenvima? / Kisplyx?, “lenvatinib”) against the comparator sorafenib as first-line treatment for unresectable hepatocellular carcinoma, will be orally presented during the 53rd Annual Meeting of the American Society of Clinical Oncology (ASCO), taking place in Chicago, the United States. In this study, lenvatinib was the first agent to demonstrate statistical non-inferiority against sorafenib in the primary endpoint of Overall Survival (OS) and showed statistically significant and clinically meaningful improvements in the secondary endpoints of Progression Free Survival (PFS), Time To Progression (TTP), and Objective Response Rate (ORR), doubling sorafenib¡®s median values and ratios.

According to the results of the study, lenvatinib (13.6 months) met the statistical criteria for non-inferiority in the primary endpoint of median OS compared to sorafenib (12.3 months). (Hazard Ratio [HR] 0.92, 95% Confidence Interval [CI] = 0.79-1.06)
Additionally, lenvatinib showed statistically significant improvements in the three secondary endpoints compared to sorafenib: median PFS (lenvatinib 7.4 months versus sorafenib 3.7 months, HR 0.66, 95% CI = 0.57-0.77, P<0.00001), median TTP (lenvatinib 8.9 months versus sorafenib 3.7 months, HR 0.63, 95% CI = 0.53-0.73, P<0.00001) and ORR (lenvatinib 24% versus sorafenib 9%, P<0.00001).
Furthermore, when overall Quality of Life (QOL) was evaluated based on the EORTC QLQ-C30 questionnaire, it was found that lenvatinib helped to delay deterioration of QOL, such as pain and diarrhea, compared to sorafenib (nominal P-value < 0.05).
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.

Based on the results of this study, Eisai will submit regulatory applications for lenvatinib for the treatment of hepatocellular carcinoma in Japan, the United States, and Europe during the first half of fiscal 2017, and China within fiscal 2017.

Liver cancer is the second leading cause of cancer related deaths and is estimated to be responsible for 750,000 deaths per year globally. Additionally, 780,000 cases are newly diagnosed each year, about 80% of which occur in Asian regions, including Japan and China. 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, and 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 generating scientific evidence aimed at maximizing the value of lenvatinib 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.