Mar 30, 2021 12:42 JST

Source: Eisai

Eisai: European Medicines Agency Accepts the Marketing Authorisation Applications for Two Additional Indications of Anti Cancer Agent Lenvatinib in Combination with Pembrolizumab
As a Treatment for Advanced Renal Cell Carcinoma and Advanced Endometrial Carcinoma

TOKYO, Mar 30, 2021 - (JCN Newswire) - 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.(1) 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.(2) 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.(3),(4)

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.(5) 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.(6)

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.

Media Inquiries:
Public Relations Department,
Eisai Co., Ltd.
+81-(0)3-3817-5120

For more information, visit https://www.eisai.com/news/2021/news202122.html.

Source: Eisai
Sectors: BioTech

Copyright ©2021 JCN Newswire. All rights reserved. A division of Japan Corporate News Network.

Related Press Release


Eisai and National Cancer Center Commence Joint Research and Development Project
May 14 2021 16:48 JST
 
Eisai's Statement of Commitment for Carbon Neutrality by 2040
May 11 2021 09:00 JST
 
Eisai and Merck & Co., Inc., Kenilworth, N.J., U.S.A. Receive Priority Review From FDA for LENVIMA (lenvatinib) Plus KEYTRUDA (pembrolizumab) Applications
May 07 2021 10:08 JST
 
RESONA and Eisai Enter Into Business Alliance Aiming to Support People Living with Dementia and to Prevent Dementia in Saitama Prefecture, Japan
April 28 2021 11:33 JST
 
Eisai: Application Submitted for Additional Indication of Anti Cancer Agent Lenvima in Combination With Keytruda as a Treatment for Advanced Uterine Body Cancer in Japan
April 23 2021 13:55 JST
 
Eisai: Gilead Sciences Submits New Drug Application in Japan for Filgotinib for the Treatment of Ulcerative Colitis with an Inadequate Response to Conventional Therapies
April 23 2021 12:02 JST
 
Notice Regarding Biogen's Disclosure About the Submission of Marketing Authorization Applications in Brazil, Canada, Australia, and Switzerland for Aducanumab for Alzheimer's Disease
April 23 2021 08:07 JST
 
Eisai: 18-Month, Pre-Specified Analysis Showing Consistent Reduction in Clinical Outcome Measures from a Lecanemab (BAN2401) Phase 2b Clinical Trial in Early Alzheimer's Disease
April 20 2021 08:23 JST
 
Eisai to Present Latest Data on Neurology Products and Pipelines at the American Academy of Neurology Annual Meeting
April 14 2021 12:49 JST
 
Eisai: Animation Featuring Lymphatic Filariasis Elimination Activities Receives Animation Award at International Society for Neglected Tropical Diseases Festival 2021
April 12 2021 12:16 JST
 
More Press release >>

Latest Press Release


More Latest Release >>