TOP PAGE
ENGLISH
JAPANESE
|
CONNECT WITH US:
Home
About
Services
Contact
Log in
*
Home
Press release
Apr 23, 2021 14:55 JST
Source:
Eisai
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
TOKYO, Apr 23, 2021 - (JCN Newswire) - 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 an application submission in Japan for the additional indication of Eisai's 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 uterine body cancer.
This application is based on the results of the pivotal Phase 3 Study 309/KEYNOTE-775 for the treatment of patients with advanced endometrial carcinoma (advanced uterine body cancer in Japan), following at least one prior platinum-based regimen, which were presented at the Society of Gynecologic Oncology (SGO) 2021 Annual Meeting on Women's Cancer in March 2021. In this trial, LENVIMA plus KEYTRUDA demonstrated a statistically significant and clinically meaningful improvement in the primary endpoints of Progression-Free Survival (PFS) and Overall Survival (OS) as well as the secondary endpoint of Objective Response Rate (ORR) versus chemotherapy (treatment of physician's choice of doxorubicin or paclitaxel). The safety profile of LENVIMA plus KEYTRUDA was consistent with previously reported studies.
LENVIMA plus KEYTRUDA has received orphan drug designation for a prospective indication for uterine body cancer by the Ministry of Health, Labour and Welfare, Japan (MHLW). Under this system, this application will be subject to priority review.
It is estimated that there were more than 417,000 new cases of uterine body cancer diagnosed worldwide and nearly 97,000 deaths from the disease in 2020. In Japan, there were more than 17,000 new cases and more than 3,000 deaths in 2020. Endometrial carcinoma 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 is highly dependent on the stage at diagnosis, and with a five-year survival rate of 17% for metastatic disease, the prognosis for these patients is poor.
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 the LENVIMA plus KEYTRUDA combination therapy to patients with cancer.
For more information, visit
https://www.eisai.com/news/2021/news202131.html
.
Source: Eisai
Sectors: BioTech
Copyright ©2025 JCN Newswire. All rights reserved. A division of Japan Corporate News Network.
Related Press Release
Eisai and Merck & Co., Inc., Rahway, NJ, USA Provide Update on Phase 3 LEAP012 Trial in Unresectable, Non-Metastatic Hepatocellular Carcinoma
October 30 2025 13:43 JST
Merck & Co., Inc. and Eisai Announce WELIREG(R) (belzutifan) Plus LENVIMA(R) (lenvatinib) Met Primary Endpoint of Progression-Free Survival (PFS) in Certain Previously Treated Patients With Advanced Renal Cell Carcinoma
October 28 2025 23:30 JST
Health Canada Grants Authorization for "LEQEMBI(R)" (lecanemab) for the Treatment of Early Alzheimer's Disease
October 27 2025 13:23 JST
LEQEMBI(R) IQLIK(TM) (lecanemab-irmb) Subcutaneous Autoinjector Named to TIME's "Best Inventions of 2025"
October 14 2025 16:54 JST
Eisai and Biogen Announce U.S. Availability of LEQEMBI(R) IQLIK(TM) (lecanemab-irmb) Subcutaneous Injection Maintenance Dose for Treatment of Early Alzheimer's Disease
October 08 2025 11:03 JST
Eisai Highlights Breadth of Oncology Research at ESMO 2025
October 03 2025 17:01 JST
"LEQEMBI(R)" (lecanemab) IV Maintenance Dosing for the Treatment of Early Alzheimer's Disease Approved in China
September 29 2025 09:33 JST
LEQEMBI(R) (Lecanemab) Approved for the Treatment of Alzheimer's Disease in Australia
September 24 2025 18:04 JST
Anti-MTBR (microtubule binding region) Tau Antibody Etalanetug Granted FDA Fast Track Designation
September 17 2025 17:20 JST
"New Answers to Dementia" Eisai Releases Concept Movie and New Content on Campaign Website for Dementia Month
September 12 2025 12:20 JST
More Press release >>
Latest Press Release
The 18th JCB World Conference Held in Incheon, Republic of Korea
Nov 07, 2025 18:00 JST
Olympus Unveils Corporate Strategy
Nov 07, 2025 15:30 JST
TANAKA's New Head Office, TANAKA Building Received The GOOD DESIGN AWARD 2025
Nov 07, 2025 04:00 JST
Honda Unveils Next-generation Technologies at "Honda Automotive Technology Workshop" for Electrified Models to be Launched in Second Half of 2020s
Nov 06, 2025 22:44 JST
Ten organizations have jointly launched a project titled "Development of Integrated Simulation Platform for Sustainable and Competitive Maritime Industry"
Nov 06, 2025 22:00 JST
Fujitsu to develop new chatbot for Japan Pension Service
Nov 06, 2025 21:24 JST
Stripe and NEC to Provide Face Recognition Payment Service via Stripe Terminal
Nov 06, 2025 17:30 JST
ESA, MediaTek, Eutelsat, Airbus, Sharp, ITRI, and R&S Announce World's First Rel-19 5G-Advanced NR-NTN Connection over OneWeb LEO Satellites
Nov 06, 2025 17:00 JST
Hybrid Dump Truck Demonstration Test at South African Mining Site Selected by UNIDO's Industrial Cooperation Programme
Nov 06, 2025 16:16 JST
Mitsubishi Power Receives Contract to Upgrade Existing Boiler Equipment at the O Mon 1 Thermal Power Plant in Vietnam
Nov 06, 2025 16:01 JST
MHI and ICM Form Strategic Alliance to Advance Ethanol Dehydration Efficiency
Nov 06, 2025 15:38 JST
JCB and Agoda Enter Long-Term Partnership to Enhance Travel and Payment Experience Across Asia
Nov 06, 2025 12:00 JST
NEC and Siemens collaborate to accelerate smart factory innovation
Nov 05, 2025 00:57 JST
Exhibiting at the Space Tech Expo Europe 2025 in Bremen, Germany
Nov 05, 2025 00:49 JST
Honda Announces Electric Motorcycle Business Brand Promise and Four Core Values
Nov 05, 2025 00:35 JST
Honda Unveils Its First Electric Motorcycle, the Honda WN7, at EICMA 2025
Nov 05, 2025 00:20 JST
Honda Unveils V3R 900 E-Compressor Prototype Equipped with V3 Engine with Electronically-controlled Compressor at EICMA 2025
Nov 05, 2025 00:00 JST
Honda Presents World Premiere of CB1000GT Sport Tourer at EICMA 2025
Nov 04, 2025 23:55 JST
New CB1000GT, global debut of Honda WN7 electric motorcycle, expansion of Honda E-Clutch line-up and V3R 900 E-Compressor Prototype lead Honda's EICMA 2025 line-up
Nov 04, 2025 23:40 JST
Honda Motorcycle Business Product Marks and New Emblem
Nov 04, 2025 23:21 JST
More Latest Release >>