TOKYO, May 7, 2021 - (JCN Newswire) - Eisai Co., Ltd.and Merck & Co., Inc., Kenilworth, N.J., U.S.A. (known as MSD outside the United States and Canada) today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted priority review for applications seeking two new approvals for 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. The first set of applications (a supplemental New Drug Application [sNDA] for LENVIMA and a supplemental Biologics License Application [sBLA] for KEYTRUDA) are for the first-line treatment of patients with advanced renal cell carcinoma (RCC), based on progression-free survival (PFS), overall survival (OS) and objective response rate (ORR) data from the pivotal Phase 3 CLEAR study (Study 307/KEYNOTE-581). The second set of applications are for the treatment of patients with advanced endometrial carcinoma who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation, based on PFS, OS, and ORR data from the pivotal Phase 3 Study 309/KEYNOTE-775 trial. These are the first applications to be submitted in the U.S. for this combination therapy based on Phase 3 clinical data. The FDA has set Prescription Drug User Fee Act (PDUFA) dates, or target action dates, of August 25 and 26, 2021, for the advanced RCC sNDA and sBLA applications, respectively, and September 3, 2021, for the advanced endometrial carcinoma applications.

"Advanced renal cell carcinoma and advanced endometrial carcinoma are aggressive cancers, and patients urgently need new treatment options that may help improve outcomes," said Dr. Gregory Lubiniecki, Vice President, Oncology Clinical Research, Merck & Co., Inc., Kenilworth, N.J., U.S.A. Research Laboratories. "We appreciate that the FDA has recognized this significant unmet need and the potential for the combination of KEYTRUDA plus LENVIMA in these patients by granting priority review for these applications."

"We are pleased that the FDA has granted priority review for LENVIMA plus KEYTRUDA--both in advanced renal cell carcinoma and advanced endometrial carcinoma--underscoring the potential significance of the outcomes observed in the CLEAR study (Study 307/KEYNOTE-581) and Study 309/KEYNOTE-775 trials," said Dr. Takashi Owa, Chief Medicine Creation Officer and Chief Discovery Officer, Oncology Business Group at Eisai. "Many patients are still in need of new and effective therapies, which fuels our commitment to advancing the development of this combination even more. These milestones reinforce our unwavering dedication to helping the patients we aim to serve."

The applications in advanced RCC are based on results from the CLEAR study (Study 307/KEYNOTE-581), in which LENVIMA plus KEYTRUDA demonstrated statistically significant improvements in PFS, OS and ORR versus sunitinib. These data were presented in February at the virtual 2021 Genitourinary Cancers Symposium (ASCO GU) and simultaneously published in the New England Journal of Medicine.

The applications in advanced endometrial carcinoma are based on results from Study 309/KEYNOTE-775, in which LENVIMA plus KEYTRUDA demonstrated statistically significant improvements in PFS, OS and ORR versus chemotherapy (investigator's choice of doxorubicin or paclitaxel), regardless of mismatch repair (MMR) status. These data were presented in March at the virtual Society of Gynecologic Oncology (SGO) 2021 Annual Meeting on Women's Cancer. Study 309/KEYNOTE-775 is the confirmatory trial for Study 111/KEYNOTE-146, which supported the 2019 accelerated approval of the combination for the treatment of patients with advanced endometrial carcinoma that is not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), who have disease progression following prior systemic therapy and are not candidates for curative surgery or radiation. This indication was an accelerated approval based on tumor response and durability of response and reviewed under the FDA's Real-Time Oncology Review pilot program and the FDA's Project Orbis. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trial.

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 14 different tumor types (endometrial carcinoma, hepatocellular carcinoma, melanoma, non-small cell lung cancer, renal cell carcinoma, squamous cell carcinoma of the head and neck, urothelial cancer, biliary tract cancer, colorectal cancer, gastric cancer, glioblastoma, ovarian cancer, pancreatic cancer and triple-negative breast cancer) across more than 20 clinical trials.

For more information, visit https://www.eisai.com/news/2021/news202133.html.

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