TOKYO, Japan I January 30, 2015 I Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today that the Phase II part of a Phase I/II clinical trial (Study 205) of its in-house developed anticancer agent lenvatinib mesylate (lenvatinib) in unresectable advanced or metastatic renal cell carcinoma has met its primary endpoint.

The second part of Study 205 was an open-label, multicenter study of lenvatinib alone, and in combination with the anticancer agent everolimus, in patients with unresectable advanced or metastatic renal cell carcinoma following one prior VEGF-targeted treatment. 153 patients were randomized in a 1:1:1 ratio to one of three treatment arms to receive either lenvatinib (18 mg) plus everolimus (5 mg), lenvatinib alone (24 mg), or everolimus alone (10 mg) to compare the safety and efficacy of these three regimens.

From the preliminary results of the study, both lenvatinib plus everolimus and the lenvatinib alone groups prolonged progression free survival (PFS), the study’s primary endpoint, compared to everolimus alone, and the lenvatinib plus everolimus group in particular showed a highly statistically significant improvement. The most common treatment-related adverse events reported in the lenvatinib plus everolimus group were diarrhea, decreased appetite, fatigue, nausea, and hypertension, and in the lenvatinib alone group were diarrhea, nausea, decreased appetite, hypertension, fatigue, and vomiting. Detailed results of the study will be presented at an academic conference in the near future.

Renal cell carcinoma is the most common form of cancer to affect the kidneys. For metastatic or advanced renal cell carcinoma that is difficult to treat with surgery, the standard treatment method is molecular targeted drug therapy, however with low 5-year survival rates, this remains a disease with significant unmet medical needs. According to the results of this study, lenvatinib plus everolimus showed superior PFS over everolimus alone which is recommended by the National Comprehensive Cancer Network guidelines as a 2nd-line therapy for unresectable advanced or metastatic renal cell carcinoma. Currently, no combination therapy for this indication has been approved in any major country worldwide. Eisai will share these study results with regulatory authorities to discuss further steps.

Lenvatinib is an oral molecular targeted agent that selectively inhibits the activities of several different molecules including VEGFR, FGFR, RET, KIT and PDGFR, involved in angiogenesis and tumor proliferation. It is the first compound that has been confirmed through X-ray crystal structural analysis to possess a novel binding mode (Type V) to VEGFR21. Furthermore, lenvatinib exhibits rapid and potent inhibition of kinase activity, according to kinetic analysis1. Currently, Eisai has already submitted regulatory applications for lenvatinib seeking indication approval for thyroid cancer to health authorities firstly in Japan, the United States and the EU, and is filing subsequent applications in other countries worldwide. Eisai has also initiated a global Phase III trial of lenvatinib in hepatocellular carcinoma and Phase II studies of lenvatinib in several other tumor types are also underway.

Eisai is committed to exploring the potential clinical benefits of lenvatinib in order to further contribute to patients with cancer and their families.


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