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European Medicines Agency Accepts Eisai Marketing Authorization Applications for Two Additional Indications of Anti Cancer Agent Lenvatinib in Combination with Pembrolizumab

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March 30, 2021

Eisai Co., Ltd. announced today that the European Medicines Agency (EMA) has confirmed it has accepted for review applications for the use of its in-house discovered multiple receptor tyrosine kinase inhibitor, lenvatinib mesylate (product name: LENVIMA / Kisplyx, “lenvatinib”), in combination with anti-PD-1 therapy pembrolizumab (brand name: KEYTRUDA), developed by Merck & Co., Inc., Kenilworth, N.J., U.S.A., (known as MSD outside the United States and Canada) as a treatment for patients with advanced renal cell carcinoma (RCC) and advanced endometrial carcinoma (EC), respectively.

The application requesting an indication of lenvatinib in combination with pembrolizumab for RCC is based on the results of the pivotal Phase 3 CLEAR study (Study 307/KEYNOTE-581) for the first-line treatment of patients with advanced RCC, which were presented at 2021 Genitourinary Cancers Symposium (ASCO GU), and simultaneously published in the New England Journal of Medicine in February 2021.

In this trial, lenvatinib plus pembrolizumab 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.

In addition, the application requesting an indication of lenvatinib in combination with pembrolizumab for EC is based on the results of the pivotal Phase 3 Study 309/KEYNOTE-775 for the treatment of patients with advanced endometrial carcinoma, following one prior platinum-based regimen in any setting, which were presented at the Society of Gynecologic Oncology (SGO) 2021 Annual Meeting on Women’s Cancer in March 2021.

In this trial, lenvatinib plus pembrolizumab demonstrated a statistically significant and clinically meaningful improvement in the primary endpoints of PFS and OS as well as the secondary endpoint of ORR versus chemotherapy (treatment of physician’s choice of doxorubicin or paclitaxel).

The safety profile of the lenvatinib plus pembrolizumab combination in these studies was generally 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.  In Europe, there were more than 138,000 new cases and more than 54,000 deaths in 2020.(1) RCC is by far the most common type of kidney cancer; about nine out of 10 kidney cancers are RCC. 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.

In 2020, it is estimated there were more than 417,000 new cases of uterine body cancer diagnosed worldwide and nearly 97,000 deaths from the disease. In Europe, there were more than 130,000 new cases and more than 29,000 deaths in 2020.5 EC is the most common type of uterine body cancer. It is considered that more than 90% of uterine body cancers occur in the endometrium.

Survival rates vary highly depending on the stage of diagnosis, and the five-year survival rates for metastatic RCC and metastatic EC are 12% and 17%, respectively. Both diseases have poor prognoses.

In March 2018, Eisai and Merck & Co., Inc., Kenilworth, N.J., U.S.A., through an affiliate, entered into a strategic collaboration for the worldwide co-development and co-commercialization of lenvatinib, both as monotherapy and in combination with the anti-PD-1 therapy pembrolizumab from Merck & Co., Inc., Kenilworth, N.J., U.S.A.

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.

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