Eisai  has submitted an application for an additional indication of its in-house discovered and developed anticancer agent Lenvima (generic name: lenvatinib mesylate) for the treatment of hepatocellular carcinoma (HCC) in Japan, the first in the world.

This application is based on the results of a multicenter, open-label, randomized, global Phase III trial (Study 304) comparing the efficacy and safety of Lenvima versus sorafenib, a standard treatment for advanced HCC, as a first-line treatment for 954 patients with unresectable HCC.

According to the results of this study, Lenvima met the statistical criteria for non-inferiority in the primary endpoint of Overall Survival (OS) compared to sorafenib. Additionally, Lenvima showed highly 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. In this study, the five most common adverse events observed in the Lenvima arm were hypertension, diarrhea, decreased appetite, weight loss and fatigue, which is consistent with the known side-effect profile of Lenvima. Lenvima is the first agent to meet the statistical criteria for non-inferiority of OS compared to sorafenib since sorafenib was approved for the treatment of HCC 10 years ago.

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 0Asian regions, including Japan and China. HCC accounts for 85% to 90% of liver cancer cases. It is estimated that there are approximately 42,000 HCC patients in Japan, with 26,000 deaths every year. Treatment options for unresectable HCC are limited and the prognosis is very poor, meaning that this is an area of high unmet medical needs.

Following the application in Japan, Eisai plans to submit regulatory applications for Lenvima for the treatment of HCC in the United States and Europe during the first half of fiscal 2017, and in China within fiscal 2017.

Lenvima is approved as a treatment for refractory thyroid cancer in over 50 countries, including the United States, Japan, and in Europe. Additionally, Lenvima in combination with everolimus is approved for the treatment of renal cell carcinoma (RCC) in the United States, and in Europe. In Europe, Lenvima was launched under the brand name Kisplyx for RCC.

Eisai positions oncology as a key therapeutic area, and is aiming to discover revolutionary new medicines with the potential to cure cancer. Eisai is committed to exploring the potential clinical benefits of Lenvima 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.