Eisai China announces that its original anti-tumor drug lenvatinib (brand name: Lenvima®) has been approved by the National Medical Products Administration (NMPA) of China, in combination with pembrolizumab and transarterial chemoembolization (TACE), for the treatment of patients with unresectable, non-metastatic hepatocellular carcinoma. The approval of this new indication is based on data from the Phase III clinical trial LEAP-012 study.
This is another significant expansion of Lenvatinib in the field of liver cancer treatment in China, marking the official implementation of the first TACE combined with systemic treatment regimen, bringing new treatment opportunities for liver cancer patients and fully demonstrating Eisai China's continuous exploration.hhc-ecosystem (hhc ecosystem), joint innovation, driving clinical practice transformation together with partners through scientific breakthroughs, extending hope for patient survival.
Lenvatinib: Deepening Commitment to Oncology, Continuously Contributing to Patients in China
In September 2018, lenvatinib (trade name: Lenvima®) was officially approved for marketing by the China National Medical Products Administration, with the first indication being unresectable hepatocellular carcinoma (HCC) patients who had not previously received systemic therapy. Since its approval in China in 2018, it has benefited tens of thousands of Chinese liver cancer patients, with an objective response rate (ORR) of 43.8% in the Chinese population (independent imaging assessment by mRECIST).1, and with the widespread clinical application, the median overall survival (OS) of first-line lenvatinib treatment has significantly extended to 26 months.2, bringing significant survival benefits to Chinese liver cancer patients.
In November 2020, lenvatinib was approved in China for its second indication, used to treat patients with progressive, locally advanced or metastatic radioactive iodine-refractory differentiated thyroid cancer. This approval was based on the positive results of the global Phase III clinical study SELECT and the Chinese 308 study.3, further expanding the application scope of lenvatinib in the field of oncology.
At the same time, Eisai China has always been committed to improving drug accessibility and assistance to low-income patients in China. Since its launch, through the "Eisai Love Continues" patient assistance program, a total of 28,756 patients have been aided, with the market value of the donated drugs exceeding 4.5 billion yuan.4。
New Indication Breakthrough: Combination Therapy Fills Clinical Gap, Meets Urgent Needs
According to data from the National Cancer Center of China, in 2022, the number of new cases of primary liver cancer in China ranked 4th among all types of newly diagnosed cancers, with an incidence rate ranking 5th. The number of deaths and mortality rate due to primary liver cancer both ranked 2nd.5Data show that approximately 64% of Chinese hepatocellular carcinoma patients are diagnosed at an intermediate to advanced stage (CNLC Stage Ⅱb, Ⅲa, and Ⅲb). Traditional TACE monotherapy has a median progression-free survival (mPFS) of about 8-10 months and an objective response rate (ORR) of around 30% (per independent radiological assessment using RECIST 1.1), highlighting the urgent need for breakthrough treatment options.6,7。
For unresectable non-metastatic hepatocellular carcinoma (HCC), traditional treatments mainly focus on TACE, but the efficacy of a single therapy is limited with a high recurrence rate in patients. The "combination regimen" of lenvatinib, pembrolizumab (PD-1 inhibitor), and TACE achieves synergistic effects through multiple mechanisms—TACE for local tumor control, lenvatinib for anti-angiogenesis combined with pembrolizumab for immune activation.
LEAP012 Global Population Clinical Data Shows8：
- The objective response rate (ORR) increased to 8% (independent imaging assessment per RECIST1.1), significantly higher than traditional TACE treatment (33.3%);
- Median Progression-Free Survival (mPFS) extended to 6 months, significantly reducing the risk of disease progression by 36%;
- The median overall survival (OS) was not reached, but a trend toward benefit was observed (HR 0.8, 95% CI 0.57-1.11).
LEAP012: The Chinese population shows more significant therapeutic benefits compared to the global population.
- ORR (1 as assessed by independent imaging) improved by 53% vs 32%;
- mPFS 16.6 months vs 6.5 months, reducing the risk of disease progression by 47%;
- The OS benefit trend was more significant than the global population (HR 0.58, 95%CI 0.34-0.97).
Academician Fan Jia of the Chinese Academy of Sciences stated: "The formal approval in China of the indication for lenvatinib combined with pembrolizumab and transarterial chemoembolization (TACE) for unresectable, non-metastatic hepatocellular carcinoma marks a milestone of strategic significance for the entire field of liver cancer treatment. The implementation of this innovative combination therapy not only signifies a solid and crucial step forward in the standardization of systemic-local treatment strategies for intermediate- to advanced-stage liver cancer but also highlights the unique clinical value and outstanding efficacy of the 'Chinese-characteristic' liver cancer treatment model, which has gained high recognition and full affirmation from the medical community. This contributes an Eastern wisdom-infused 'Chinese solution' to the global landscape of liver cancer treatment, reshaping new paradigms for intermediate- to advanced-stage liver cancer treatment and continuously leading breakthroughs. This combination therapy truly lights the beacon of hope for long-term survival for a broad population of patients with unresectable hepatocellular carcinoma, contributing to the 'Healthy China' strategy."
Ms. Feng Yanhui, Senior Vice President of Eisai Global and President of Eisai China, emphasized: "Lenvatinib is one of Eisai's core products in the oncology field. This breakthrough in combination therapy not only responds to the cancer prevention and treatment goals outlined in the 'Healthy China 2030' Plan, but also reflects Eisai China's urgent desire to address unmet needs of Chinese patients through the localization of global innovations. In the future, we will accelerate the clinical benefits for patients and explore more combination treatment options to help improve the five-year survival rate of liver cancer in China."
Eisai China has always adhered to the principle of "caring for human health" (i.e.“hhc", human health care)" The corporate philosophy places patient benefits and public health as the top priority, meeting their diverse needs and contributing to the improvement of their well-being. Eisai China will continue to collaborate with all parties to jointly promote the accessibility and affordability of high-quality innovative drugs in China. By providing high-quality, safe, and effective pharmaceuticals and services, it aims to bring hope and good news to more patients.
References
- Reference citation: Lenvatinib Instructions
- Citation Reference: 2024 APASL Releases Leap002 China Subgroup Analysis
- Cited references, including SELECT, 308, and the lenvatinib package insert
- Internal Data
- Han BF, Zheng RS, Zeng HM, et al. Cancer incidence and mortality in China, 2022. J Natl Cancer Cent. 2024 Feb 2;4(1):47-53.
- Chinese Expert Consensus on the Conversion and Perioperative Treatment of Primary Liver Cancer (2024 Edition)
- Cite the published articles of Leap012 and EMERALD-1
- Citing leap012 published articles and approved data