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KEYTRUDA® (pembrolizumab) Plus LENVIMA® (lenvatinib) Approved in Japan for Patients With Unresectable, Advanced or Recurrent Endometrial Carcinoma That Progressed After Cancer Chemotherapy

Published: 2021-12-27 11:45:00 ET

First Approval in Japan for the KEYTRUDA Plus LENVIMA Combination

KENILWORTH, N.J. & TOKYO--(BUSINESS WIRE)-- Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Eisai today announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved the combination of KEYTRUDA, Merck’s anti-PD-1 therapy, plus LENVIMA, the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai, for the treatment of patients with unresectable, advanced or recurrent endometrial carcinoma that progressed after cancer chemotherapy. This approval marks the first time the combination of KEYTRUDA plus LENVIMA has been approved in Japan. KEYTRUDA plus LENVIMA is now approved in Japan, the U.S. and Europe for certain types of advanced endometrial carcinoma.

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“Rates of endometrial carcinoma have been steadily increasing in Japan each year, and there are limited options for patients who are diagnosed at an advanced stage or find their disease has returned,” said Dr. Gregory Lubiniecki, Vice President, Clinical Research, Merck Research Laboratories. “With today’s approval, patients in Japan with unresectable, advanced or recurrent endometrial carcinoma now have the option of the first immunotherapy and tyrosine kinase inhibitor combination that has significantly improved overall survival and progression-free survival compared to chemotherapy.”

“This is the first approval of the KEYTRUDA plus LENVIMA combination in Japan,” said Terushige Iike, President, Eisai Japan at Eisai. “We thank the patients, families and healthcare providers who made this approval possible. By delivering this combination therapy, we are proud to provide patients with advanced or recurrent endometrial carcinoma an additional treatment option.”

The approval is based on results from the pivotal Phase 3 KEYNOTE-775/Study 309 trial, in which KEYTRUDA plus LENVIMA demonstrated statistically significant improvements in overall survival (OS), reducing the risk of death by 38% (HR=0.62 [95% CI, 0.51-0.75]; p

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All statements made via social media sites sponsored or maintained by Enhanced Investments and its affiliates are for informational purposes only and do not constitute a comprehensive description of Enhanced Investments' investment advisory services.
Certain investments are not suitable for all investors. Before investing, consider your investment objectives and applicable fees. The rate of return on investments can vary widely over time, especially for long term investments. Investment losses are possible, including the potential loss of all amounts invested. Information provided by Enhanced Investments is for informational and general educational purposes only and is not investment or financial advice.