TOKYO, July 29, 2025 - (JCN Newswire) - Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today that its in-house discovered tyrosine kinase inhibitor, “LENVIMA®” (generic name: lenvatinib mesylate), in combination with the anti-PD-1 antibody, pembrolizumab, and transarterial chemoembolization (TACE) has been approved by the National Medical Products Administration (NMPA) of China for unresectable, non-metastatic hepatocellular carcinoma.

This approval is based on interim analysis results from the pivotal Phase III LEAP-012 trial. The results of this trial were presented at the European Society for Medical Oncology (ESMO) Annual Congress 2024 held in September 20241 and published in The Lancet in January 2025.2 In this trial, LENVIMA in combination with pembrolizumab and TACE (the "combination therapy") demonstrated a statistically significant and clinically meaningful improvement in one of the trial’s primary endpoints, progression-free survival (PFS), reducing the risk of disease progression or death by 34% (Hazard Ratio [HR]=0.66 [95% Confidence Interval (CI), 0.51-0.84]; p=0.0002) compared to TACE alone*.2 Median PFS was 14.6 months(95% CI, 12.6-16.7) in the combination therapy and 10.0 months (95% CI, 8.1-12.2) in TACE alone. 2 At this analysis, a trend toward improvement in overall survival (OS), the trial’s other primary endpoint, was observed for the combination therapy versus TACE alone (HR=0.80 [95% CI, 0.57-1.11]; p=0.087). 2

237 patients received the combination therapy and 241 patients received TACE alone.2 Treatment Emergent Adverse Events (TEAEs) occurred in 99.6% (n=236) of patients receiving the combination therapy versus 96.7% (n=233) of patients receiving TACE alone and led to the discontinuation of both study drugs in 13.1% (n=31) versus 4.1% (n=10) of patients, respectively.2 Grade 3, 4, or 5 TEAEs occurred in 82.3% (n=195) of patients receiving the combination therapy versus 47.7% (n=115) for TACE alone and TEAEs led to death in 4.2% (n=10) versus 2.5% (n=6) of patients, respectively.2

Liver cancer is one of the leading causes of cancer-related deaths worldwide.3 In 2022, it was estimated there were more than 865,000 new cases globally and 367,000 in China, with more than 757,000 deaths worldwide, including 316,000 in China.3,4 China is estimated to account for more than 40% of global new cases and deaths.3,4 Hepatocellular carcinoma (HCC) is the most common type of liver cancer, representing approximately 90% of primary liver cancer cases.5 TACE has been a standard of care for patients with unresectable, non-metastatic HCC for many years. However, since many patients experience disease progression within one year6,7,8,9, new treatment options have been sought.

LENVIMA monotherapy has been approved for the treatment of patients with unresectable HCC in more than 80 countries, including in Japan, the U.S., Europe and China and has made contributions to many patients to date. With this approval, it is expected that LENVIMA will further expand its contribution to patients with hepatocellular carcinoma in China.

Eisai positions oncology as a key therapeutic area and is aiming to discover innovative new medicines with the potential to cure cancer. Eisai is committed to expanding the potential clinical benefits of lenvatinib for cancer treatment, as it seeks to contribute to addressing the diverse needs of, and increasing the benefits provided to, patients with cancer, their families and healthcare professionals.

In March 2018, Eisai and Merck & Co., Inc., Rahway, through an affiliate, entered into a strategic collaboration for the worldwide co-development and co-commercialization of lenvatinib.

*TACE alone: In addition to TACE, oral placebo and intravenous placebo corresponding to LENVIMA and pembrolizumab were administered.

For more details, please visit: https://www.eisai.com/news/2025/pdf/enews202551pdf.pdf

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Eisai Co., Ltd.
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