|
Tuesday, 30 March 2021, 11:42 HKT/SGT | |
| | | | Source: Eisai | |
|
|
|
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.
Topic: Press release summary
Source: Eisai
Sectors: BioTech
http://www.acnnewswire.com
From the Asia Corporate News Network
Copyright © 2024 ACN Newswire. All rights reserved. A division of Asia Corporate News Network.
|
|
|
|
|
|
Eisai |
Apr 18, 2024 09:53 HKT/SGT |
Eisai: Research on Treatments for Alzheimer's Disease Based on Its Pathological Mechanisms Recieves Award for Science and Technology (Research Category) |
Apr 17, 2024 15:17 HKT/SGT |
Eisai's Antiepileptic Drug Fycompa Injection Formulation Launched In Japan |
Apr 3, 2024 15:24 HKT/SGT |
French Sales Subsidiary Eisai S.A.S. to Divest Rights for Loxapac And Parkinane LP to CNX Therapeutics |
Apr 1, 2024 08:39 HKT/SGT |
Eisai Completes Submission of LEQEMBI (lecanemab-irmb) Supplemental Biologics License Application for IV Maintenance Dosing for the Treatment of Early Alzheimer's Disease to the U.S. FDA |
Mar 29, 2024 14:51 HKT/SGT |
Eisai to Divest Rights for Merislon and Myonal in Japan to Kaken Pharmaceutical |
Mar 29, 2024 14:19 HKT/SGT |
Eisai's Brain Health Self-Check Tool "NouKNOW" is Certified as "ME-BYO BRAND" by Kanagawa Prefecture |
Mar 29, 2024 13:32 HKT/SGT |
Eisai: Discovery Research on Dual Orexin Receptor Antagonist Lemborexant Honored with PSJ Award for Drug Research and Development 2024 |
Mar 21, 2024 16:36 HKT/SGT |
Lifenet and Eisai Co-Develop Dementia Insurance "be" |
Mar 21, 2024 15:10 HKT/SGT |
Eisai Selected as a Nadeshiko Brand 2024 as a Listed Company Excelling in Promotion of Women in the Workplace |
Mar 6, 2024 16:47 HKT/SGT |
Eisai Invests in C2N to Support Simplifying the Diagnosis of Early Alzheimer's Disease to Better Serve Patients |
More news >> |
|
|
|
|