Eisai’s LENVIMA (LENVATINIB) Capsules Approved for First-Line Treatment of Unresectable Hepatocellular Carcinoma (HCC) in South Korea

Tokyo, Septembe 02, 2018: Eisai Co., Ltd. announced that its South Korea subsidiary Eisai Korea Inc. received approval for the kinase inhibitor LENVIMA (lenvatinib mesylate) as a single agent for the first-line treatment of patients with unresectable hepatocellular carcinoma (HCC) from the Ministry of Food and Drug Safety (MFDS) in South Korea. An application seeking approval of LENVIMA for use in the treatment of unresectable HCC was submitted in South Korea in March 2018. This approval for LENVIMA in South Korea marks the second in Asia following approval in Japan. LENVIMA is the first new treatment option approved in ten years as a first-line systemic treatment for HCC in South Korea.

In March 2018, Eisai and Merck & Co., Inc., Kenilworth, N.J., U.S.A, through an affiliate, entered into a strategic collaboration for the worldwide co-development and co-commercialization of LENVIMA. The companies are expected to commence co-commercialization efforts for LENVIMA in South Korea by the end of 2018.

This approval was based on results from REFLECT (Study 304), an open-label, Phase III trial where LENVIMA demonstrated a treatment effect on overall survival (OS)(1) by statistical confirmation of non-inferiority when compared with the standard of care, sorafenib, in 954 patients with previously untreated unresectable HCC. LENVIMA also demonstrated statistically significant superiority and clinically meaningful improvements in progression-free survival (PFS)(2) and objective response rate (ORR)(3).

REFLECT showed that LENVIMA achieved the primary endpoint, demonstrating a treatment effect on OS by statistical confirmation of non-inferiority to sorafenib. Patients treated with LENVIMA experienced a median OS of 13.6 months compared to 12.3 months with sorafenib (Hazard Ratio [HR]: 0.92; 95% Confidence Interval [CI]: 0.79-1.06). The OS analysis was conducted as prespecified in the statistical analysis plan when 351 events had occurred in the LENVIMA arm and 350 events had occurred in the sorafenib arm. Regarding secondary efficacy endpoints, according to independent imaging review based on mRECIST criteria, LENVIMA showed statistically significant superiority and clinically meaningful improvements as compared to sorafenib in median PFS: LENVIMA 7.3 months versus sorafenib 3.6 months (HR: 0.64; 95% CI: 0.55-0.75; p
Liver cancer is the second leading cause of cancer related deaths and is estimated to be responsible for approximately 750,000 deaths per year globally. Additionally, approximately 780,000 cases are newly diagnosed each year, about 80% of which occur in Asian regions.(1) HCC accounts for 85% to 90% of primary liver cancer cases. Unresectable HCC, for which treatment options are limited, is extremely difficult to treat, and the development of new treatments is necessary.

LENVIMA has been approved as a treatment for refractory thyroid cancer in over 50 countries including the United States, Japan, in Europe and Asia, and as combination with everolimus as a second-line treatment for RCC in over 45 countries including the United States and in Europe.

Since the initial launch, more than 10,000 patients have been treated with LENVIMA, which is approved in more than 50 countries worldwide. In Japan, approximately 3,000 HCC patients have been treated with LENVIMA since the approval of the HCC indication in March 2018.

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, in collaboration with Merck & Co., Inc., Kenilworth, N.J., U.S.A., as it seeks to contribute further to addressing the diverse needs of, and increasing the benefits provided to cancer patients, their families, and healthcare providers worldwide.

(1) Overall Survival (OS): The time period from the commencement of cancer treatment up until death by any cause. Whether the cause of death is cancer or not is not taken into consideration for this variable.
(2) Progression Free Survival (PFS): PFS is the objectively confirmed time from the commencement of cancer treatment to the date of disease progression, or date of death from any cause, whichever occurs first.
(3) Objective Response Rate (ORR): ORR is the combined proportion of patients whose tumor was eliminated (complete response) and whose tumor was reduced by over 30% in size (partial response) as verified by imaging assessment.

Corporate Comm India(CCI Newswire)