Top Page | English | 简体中文 | 繁體中文 | 한국어 | 日本語
Friday, 26 May 2023, 13:15 HKT/SGT

Source: Eisai
LENVIMA (lenvatinib) Plus KEYTRUDA (pembrolizumab) Demonstrates Long-Term, Durable Survival Benefit Versus Sunitinib as First-Line Treatment for Patients With Advanced Renal Cell Carcinoma
After four years of follow-up, LENVIMA plus KEYTRUDA reduced the risk of death by 21% versus sunitinib in the pivotal Phase 3 CLEAR (Study 307)/KEYNOTE-581 trial
Final results will be presented at ASCO 2023 in an oral abstract session

TOKYO, May 26, 2023 - (JCN Newswire) - Eisai and Merck & Co., Inc., Rahway, NJ, USA (known as MSD outside of the United States and Canada) today announced data from the final pre-specified overall survival (OS) analysis of the pivotal Phase 3 CLEAR (Study 307)/KEYNOTE-581 trial investigating LENVIMA, the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai, plus KEYTRUDA, Merck's anti-PD-1 therapy, for the first-line treatment of patients with advanced renal cell carcinoma (RCC). These data will be presented on Monday, June 5 at 11:54 a.m. Central Daylight Time during an oral abstract session at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract #4502).

After four years of follow-up, LENVIMA plus KEYTRUDA maintained a clinically meaningful OS benefit versus sunitinib, reducing the risk of death by 21% (HR=0.79 [95% CI, 0.63-0.99]). The 24- and 36-month estimated OS rates were 80.4% and 66.4% for LENVIMA plus KEYTRUDA versus 69.6% and 60.2% for sunitinib, respectively. Results from the final pre-specified OS analysis were consistent with the superior results versus sunitinib from the primary OS analysis of the CLEAR/KEYNOTE-581 trial.

Additionally, LENVIMA plus KEYTRUDA reduced the risk of disease progression or death by 53% (HR=0.47 [95% CI, 0.38-0.57]), with a median progression-free survival (PFS) of 23.9 months (95% CI, 20.8-27.7) for LENVIMA plus KEYTRUDA versus 9.2 months (95% CI, 6.0-11.0) for sunitinib; the objective response rate (ORR) was 71.3% (95% CI, 66.6-76.0) with a complete response (CR) rate of 18.3% for LENVIMA plus KEYTRUDA versus an ORR of 36.7% (95% CI, 31.7-41.7) with a CR rate of 4.8% for sunitinib.

There were no new safety signals and the safety profile at the final OS analysis was consistent with the primary analysis. Grade ≥3 treatment-related adverse events (TRAE) occurred in 74.1% of patients who received LENVIMA plus KEYTRUDA versus 60.3% of patients who received sunitinib. The six most common TRAEs of any grade of patients in the LENVIMA plus KEYTRUDA arm were diarrhea (56.0%), hypertension (54.3%), hypothyroidism (44.9%), decreased appetite (35.5%), fatigue (34.1%) and stomatitis (32.7%). In the sunitinib arm, the six most common TRAEs of any grade were diarrhea (45.3%), hypertension (40.3%), stomatitis (37.4%), palmar-plantar erythrodysesthesia (36.2%), fatigue (32.9%) and nausea (28.2%).

"LENVIMA plus KEYTRUDA continues to demonstrate durable clinical benefit as a first-line treatment for patients with advanced renal cell carcinoma, as shown by the clinically meaningful improvement in overall survival sustained with four years of follow up," said Dr. Thomas Hutson, DO, Pharm.D., FACP, Director of the Urologic Oncology Program and Co-chair of the Urologic Cancer Research and Treatment Center, Texas Oncology at Baylor Sammons Cancer Center. "Furthermore, these data also showed clinically meaningful improvements in median PFS and ORR compared to sunitinib. These findings reinforce the important role of LENVIMA plus KEYTRUDA as a first-line standard of care treatment option for patients with advanced renal cell carcinoma."

"Long-term follow up data from the CLEAR/KEYNOTE-581 trial show the responses to first-line use of KEYTRUDA plus LENVIMA were durable for many of these patients," said Dr. Gregory Lubiniecki, Vice President, Global Clinical Development, Merck Research Laboratories. "Through our joint clinical development program with Eisai, we're continuing to advance our research evaluating KEYTRUDA plus LENVIMA for other challenging cancers as we strive to help even more patients."

"At the final pre-specified analysis, LENVIMA plus KEYTRUDA continued to demonstrate clinically meaningful efficacy across PFS, ORR and OS, providing patients and their physicians with new information about treating people living with advanced renal cell carcinoma," said Corina Dutcus, M.D., Senior Vice President, Clinical Development, Oncology at Eisai Inc. "These results are a testament to our steadfast commitment to people living with advanced cancers, and we are grateful for the support from the patients, families and healthcare provider community for their participation in this research."

LENVIMA plus KEYTRUDA is approved in the U.S., the EU, Japan and other countries for the treatment of advanced RCC and certain types of advanced endometrial carcinoma. Lenvatinib is marketed as KISPLYX for advanced RCC in the EU. Eisai and Merck are studying the LENVIMA plus KEYTRUDA combination through the LEAP (LEnvatinib And Pembrolizumab) clinical program in various tumor types, including but not limited to endometrial carcinoma, hepatocellular carcinoma, non-small cell lung cancer, RCC, head and neck cancer, gastric cancer and esophageal cancer across multiple clinical trials.

For more information, visit

Eisai Co., Ltd.
Public Relations:

Investor Relations:
+81-(0) 3-3817-5122

Merck & Co., Inc., Rahway, NJ, USA

Media Relations
Julie Cunningham: +1-(617) 519-6264
John Infanti: +1-(609) 500-4714

Investor Relations
Peter Dannenbaum: +1-(732) 594-1579
Damini Chokshi: +1-(732) 594-1577

Topic: Press release summary
Source: Eisai

Sectors: BioTech
From the Asia Corporate News Network

Copyright © 2023 ACN Newswire. All rights reserved. A division of Asia Corporate News Network.

May 25, 2023 20:02 HKT/SGT
Eisai's Initiatives for Developing New Medicines for Neglected Tropical Diseases and Malaria
May 24, 2023 17:03 HKT/SGT
Eisai Delivers New Data and Highlights Continued Progress of Oncology Portfolio and Pipeline at ASCO 2023
May 20, 2023 09:20 HKT/SGT
Eisai Submits Marketing Authorization Application for Lecanemab as Treatment for Early Alzheimer's Disease in Great Britain
May 16, 2023 08:27 HKT/SGT
Health Canada Accepts New Drug Submission for Lecanemab as Treatment for Early Alzheimer's Disease
May 8, 2023 10:15 HKT/SGT
Eisai Enters Into Joint Development Agreement with Blissbio for Antibody Drug Conjugate BB-1701 with Option Rights for Strategic Collaboration
Apr 6, 2023 17:32 HKT/SGT
Eisai Completes a Major Renovation of Tsukuba Research Laboratories
Apr 4, 2023 12:23 HKT/SGT
Eisai Publishes Long-Term Health Outcomes Using Simulation Model of Lecanemab Using Phase 3 Clarity Ad Data in Peer-Reviewed Neurology and Therapy Journal
Apr 3, 2023 12:06 HKT/SGT
Eisai Enters Into Agreement With National Cancer Center to Collaborate on Investigator-Initiated Clinical Research for Anticancer Agent Tazemetostat Based on "Patient-Proposed Healthcare Services" System
Mar 31, 2023 15:51 HKT/SGT
Eisai Presented New Analyses of Aria and QOL on Lecanemab in Clarity AD at the AD/PD 2023 Annual Meeting
Mar 31, 2023 13:55 HKT/SGT
Eisai: Additional Detailed Analyses from Phase 2 Study 201 of Lecanemab Published as Three Papers in Peer-Reviewed Journals
More news >>
 News Alerts
Copyright © 2023 ACN Newswire - Asia Corporate News Network
Home | About us | Services | Partners | Events | Login | Contact us | Privacy Policy | Terms of Use | RSS
US: +1 214 890 4418 | Beijing: +86 400 879 3881 | Hong Kong: +852 8192 4922 | Singapore: +65 6549 7068 | Tokyo: +81 3 6859 8575

Connect With us: