|
| Thursday, 20 January 2022, 08:56 HKT/SGT | |
| |  | |
Source: Eisai | |
|
|
|
|
| Published in the New England Journal of Medicine |
TOKYO, Jan 20, 2022 - (JCN Newswire) - Eisai and Merck & Co., Inc., Kenilworth, N.J., U.S.A. (known as MSD outside the United States and Canada) today announced the publication of results from the Phase 3 Study 309/KEYNOTE-775 trial in the January 19, 2022 edition of the New England Journal of Medicine. The pivotal study evaluated the combination of LENVIMA, the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai, plus KEYTRUDA, the anti-PD-1 therapy from Merck & Co., Inc., Kenilworth, N.J., U.S.A. versus chemotherapy (treatment of physician's choice of doxorubicin or paclitaxel) for patients with advanced endometrial carcinoma following at-least one prior platinum-based regimen in any setting.
The publication includes previously reported data that was first presented in an oral plenary session at the virtual Society of Gynecologic Oncology (SGO) 2021 Annual Meeting on Women's Cancer.(1) Results showed that the LENVIMA plus KEYTRUDA combination demonstrated statistically significant improvements in the dual primary endpoints of overall survival (OS) and progression-free survival (PFS) compared to chemotherapy. Objective response rate (ORR) data and additional detailed efficacy and safety data, including subgroup analyses, are also featured in the publication.
"While rates of endometrial carcinoma continue to rise globally, patients with advanced or recurrent disease have limited options available to them once the disease progresses following platinum-based chemotherapy," said Dr. Gregory Lubiniecki, Vice President, Oncology Clinical Research, Merck Research Laboratories. "KEYNOTE-775/Study 309 is an important Phase 3 study that supported recent approvals of KEYTRUDA plus LENVIMA for certain types of advanced endometrial carcinoma in the U.S. and other countries around the world, where it became the first immunotherapy and tyrosine kinase inhibitor combination approved for these patients."
"The Phase 3 Study 309/KEYNOTE-775 trial demonstrates the ongoing commitment that Eisai and Merck & Co., Inc., Kenilworth, N.J., U.S.A. share in addressing the unmet needs of people living with difficult-to-treat cancers, including advanced endometrial carcinoma," said Corina Dutcus, M.D., Senior Vice President, Clinical Research, Oncology Business Group at Eisai Inc. "The publication of this study in the New England Journal of Medicine reflects the importance of our joint research in exploring the potential of the LENVIMA plus KEYTRUDA combination."
The publication contains results for the all-comer population, including the mismatch repair deficient (dMMR) patient population for which LENVIMA plus KEYTRUDA is not approved in the U.S.
Based on the results from the Phase 3 Study 309/KEYNOTE-775 trial, LENVIMA plus KEYTRUDA has been approved in the U.S. for patients with advanced endometrial carcinoma that is not microsatellite instability-high or dMMR, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation. LENVIMA plus KEYTRUDA is also approved in the European Union and Japan for certain patients with advanced or recurrent endometrial carcinoma regardless of mismatch repair status. Eisai and Merck & Co., Inc., Kenilworth, N.J., U.S.A. are studying the LENVIMA plus KEYTRUDA combination through the LEAP (LEnvatinib And Pembrolizumab) clinical program in more than 10 different tumor types across more than 20 clinical trials.
(1) Eisai co., Ltd. Home page. "LENVIMA (lenvatinib) Plus KEYTRUDA (pembrolizumab) Significantly Improved Progression-Free Survival and Overall Survival Versus Chemotherapy in Patients With Advanced Endometrial Cancer Following Prior Platinum-Based Chemotherapy in Phase 3 Study". https://www.eisai.com/news/2021/news202116.html
Eisai Co., Ltd.
Public Relations:
+81-(0)3-3817-5120
Investor Relations:
+81-(0) 70-8688-9685
Merck & Co., Inc., Kenilworth, N.J., U.S.A.
Media Relations
Melissa Moody: +1-(215) 407-3536
Nikki Sullivan: +1-(718) 644-0730
Investor Relations
Peter Dannenbaum: +1- (908) 740-1037
Raychel Kruper: +1-(908) 740- 2107
For more information, visit https://www.eisai.com/news/2022/news202207.html.
Topic: Press release summary
Source: Eisai
Sectors: BioTech
http://www.acnnewswire.com
From the Asia Corporate News Network
Copyright © 2022 ACN Newswire. All rights reserved. A division of Asia Corporate News Network.
|
|
|
|
|
|
|
| Eisai |
| May 10, 2022 10:23 HKT/SGT |
|
Eisai Completes Rolling Submission to the U.S. FDA for Biologics License Application of Lecanemab for Early Alzheimer's Disease Under the Accelerated Approval Pathway |
| May 10, 2022 10:00 HKT/SGT |
|
Eisai Initiates Preparation for New Drug Application, Based on the Results of an Investigator-Initiated Clinical Trial of Ultrahigh-Dose Mecobalamin for Amyotrophic Lateral Sclerosis in Japan |
| Apr 1, 2022 13:05 HKT/SGT |
|
Eisai Announces Acquisition of Arteryex Shares (Making Arteryex a Subsidiary) to Strengthen and Rapidly Expand the Foundation of its Digital Solution Business |
| Mar 28, 2022 21:38 HKT/SGT |
|
Eisai: Announcement About an Approval for Additional Indication of Jyseleca, JAK inhibitor |
| Mar 22, 2022 09:21 HKT/SGT |
|
Eisai: Latest Findings on Lecanemab Presented at AD/PD 2022 Annual Meeting |
| Mar 15, 2022 12:03 HKT/SGT |
|
Eisai: Economic Arrangements of Amendment to Alzheimer's Disease Treatment Collaboration Agreement with Biogen |
| Mar 15, 2022 11:00 HKT/SGT |
|
Biogen and Eisai Amend Collaboration Agreements on Alzheimer's Disease Treatments |
| Mar 11, 2022 11:15 HKT/SGT |
|
Eisai to Present New Lecanemab Data Exploring Distinct Mechanism of Action and Clinical Outcomes, Disease State (DSE) Symposium, and Other Pipeline Assets at the AD/PD 2022 Annual Meeting |
| Mar 9, 2022 15:06 HKT/SGT |
|
Eisai Certified as the 2022 Health and Productivity Management Outstanding Organization (White 500) |
| Mar 7, 2022 12:50 HKT/SGT |
|
LENVIMA in Combination with KEYTRUDA Approved In Taiwan for the Treatment of Patients with Advanced Endometrial Carcinoma |
| More news >> |
 |
|
|
|
