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Eisai: Application Submitted for Additional Indication of Anti Cancer Agent Lenvima in Combination With Keytruda as a Treatment for Advanced Renal Cell Carcinoma in Japan

TOKYO, Mar 31, 2021 – (JCN Newswire via SEAPRWire.com) – Eisai Co., Ltd. and MSD K.K. a subsidiary of Merck & Co., Inc., Kenilworth, N.J., U.S.A., (known as MSD outside the United States and Canada) announced today that Eisai has submitted an application in Japan for the additional indication of its in-house discovered and developed multiple receptor tyrosine kinase inhibitor, LENVIMA (generic name: lenvatinib mesylate), in combination with Merck & Co., Inc., Kenilworth, N.J., U.S.A.’s KEYTRUDA (generic name: pembrolizumab) as a treatment for patients with advanced renal cell carcinoma (RCC). This is the first application to be submitted in Japan for this combination therapy.

This application is based on the results of the Phase 3 CLEAR study (Study 307/KEYNOTE-581) for the first-line treatment of patients with advanced RCC, which were presented at the 2021 Genitourinary Cancers Symposium (ASCO GU), and simultaneously published in the New England Journal of Medicine in February 2021. In this trial, LENVIMA plus KEYTRUDA demonstrated statistically significant and clinically meaningful improvements in the primary endpoint of progression-free survival (PFS) as well as key secondary endpoints of overall survival (OS) and objective response rate (ORR) versus sunitinib. The safety profile of LENVIMA plus KEYTRUDA was consistent with previously reported studies.

Worldwide, it is estimated that there were more than 430,000 new cases of kidney cancer diagnosed and nearly 180,000 deaths from the disease in 2020.1 In Japan, there were more than 25,000 new cases and 8,000 deaths in 2020.2 RCC is by far the most common type of kidney cancer; about nine out of 10 kidney cancers are RCC.3 Most cases of RCC are discovered incidentally during imaging tests for other abdominal diseases. Approximately 30% of patients with RCC will have metastatic disease at diagnosis, and as many as 40% will develop metastases after primary surgical treatment for localized RCC.4,5 Survival is highly dependent on the stage at diagnosis, and with a five-year survival rate of 12% for metastatic disease, the prognosis for these patients is poor.6

Eisai and MSD have been collaborating through the provision of information on LENVIMA in Japan since October 2018, and will work together to expedite the maximization of contribution by LENVIMA and KEYTRUDA to patients with cancer.

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