▎WuXi AppTec Content Team Report

Today (October 12), the official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration announced that the new indication application for Eisai's Lenvatinib Mesylate Capsules has been accepted, with the specific indication yet to be disclosed.LenvatinibAn orally administered multikinase inhibitor developed for Eisai Co., Ltd., which has been previously approved for multiple cancer indications worldwide.

Screenshot source:CDE Official Website

Public information shows,Lenvatinib is an orally administered multi-kinase inhibitor., it can selectively inhibit the activity of multiple kinases, including vascular endothelial growth factor receptors (VEGFR1, VEGFR2, and VEGFR3), as well as fibroblast growth factor receptors (FGFR1, FGFR2, FGFR3, and FGFR4). Additionally, it targets receptor tyrosine kinases associated with pathogenic angiogenesis, tumor growth, and cancer progression, such as platelet-derived growth factor receptor α (PDGFRα), KIT, and RET.

Lenvatinib as a single agent has been approved in Japan, the United States, Europe, China, and other countries and regions.For first-line treatment of thyroid cancer and hepatocellular carcinoma, and has also been approved for treatment in Japan.Thymic Cancer。LenvatinibThe combination therapy with everolimus has been approved in the United States, Europe, and Asia for second-line treatment of renal cell carcinoma; the combination therapy with the anti-PD-1 monoclonal antibody pembrolizumab has been approved in multiple regions for first-line treatment of renal cell carcinoma and endometrial cancer previously treated with systemic therapy, among others.

According to the latest pipeline information on Eisai's official website, there are three ongoing international multi-center (including China) phase III clinical trials for lenvatinib, targeting indications including:Combination with transarterial chemoembolization (TACE) as first-line treatment for hepatocellular carcinoma (LEAP-012 study); combination with chemotherapy as first-line treatment for esophageal cancer (LEAP-014); combination with chemotherapy as first-line treatment for gastric cancer (LEAP-015).

At this year's American Society of Clinical Oncology (ASCO) Annual Meeting, researchers also presented the results of the LEAP-012 study, which aimed to evaluate the efficacy of pembrolizumab plus lenvatinib combined with TACE versus dual placebo plus TACE in patients with unresectable, non-metastatic hepatocellular carcinoma (HCC). The study showed that after a median follow-up of 25.6 months, pembrolizumab plus lenvatinib combined with TACE demonstrated statistically significant and clinically meaningful improvements in progression-free survival compared to TACE alone.Reduced the risk of disease progression or death by 34%The median progression-free survival period for the pembrolizumab + lenvatinib regimen was 14.6 months, while the median progression-free survival period for the TACE regimen was 10.0 months.

ExpectationsThe subsequent clinical studies of Lenvatinib are proceeding smoothly, and it is expected to bring new treatment options to more patients as soon as possible.

[2] Eisai Official Website R&D Pipeline. Retrieved Aug 2, 2024, from https://www.eisai.com/innovation/research/pipeline/index.html

[3]LEAP-012: Pembrolizumab Plus Lenvatinib Added to TACE Improved Progression-Free Survival in HCC. Retrieved Sep 16, 2024, from https://ascopost.com/news/september-2024/leap-012-pembrolizumab-plus-lenvatinib-added-to-tace-improved-progression-free-survival-in-hcc/