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Eisai: Results From Pivotal Phase 3 Study 309/KEYNOTE-775 Trial of LENVIMA (lenvatinib) Plus KEYTRUDA (pembrolizumab) in Advanced Endometrial Carcinoma

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3 minutes

TOKYO, Jan 20, 2022 - (JCN Newswire via SEAPRWire.com) - 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...

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Eisai and Merck & Co., Inc., Kenilworth, N.J., U.S.A. Receive Priority Review From FDA for LENVIMA (lenvatinib) Plus KEYTRUDA (pembrolizumab) Applications

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4 minutes

TOKYO, May 7, 2021 - (JCN Newswire via SEAPRWire.com) - 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 OR...

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LENVIMA (lenvatinib) Plus KEYTRUDA (pembrolizumab) Combination Demonstrated Statistically Significant Improvement in OS, PFS and ORR

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4 minutes

TOKYO, Dec 17, 2020 - (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 pivotal Phase 3 Study 309/KEYNOTE-775 trial evaluating the investigational use 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., met its dual primary endpoints of overall survival (OS) and progression-free survival (PFS) and its secondary efficacy endpoint of objective response rate (ORR) in patients with advanced endometrial cancer, following at least one prior platinum-based regimen. These positive results were observed in the mismatch repair proficient (pMMR) subgroup and the intention-to-treat (ITT) study population, which includes both patients with endometrial carcinoma that is pMMR as well as patients whose disease is microsatellite instability-high (MSI-H)/mismatch repair deficient (dMMR). Based on an analysis conducted by an independent Data Monitoring Committee, LENVIMA plus KEYTRUDA demonstrated a statistically significant and clinically meaningful impro...