![]() ![]() In accordance with accelerated approval regulations, continued approval was contingent upon verification and description of clinical benefit these accelerated approval requirements have been fulfilled with the data from Study 309/KEYNOTE-775. KEYNOTE-775/Study 309 is the confirmatory trial for KEYNOTE-146/Study 111, which supported the U.S. LENVIMA plus KEYTRUDA was previously approved under accelerated approval process in Taiwan, 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 based on data from the Study 111/KEYNOTE-146 trial. Background Pembrolizumab plus lenvatinib is a novel combination with promising efficacy in patients with advanced and recurrent endometrial cancer. These results were presented at the Society of Gynecologic Oncology (SGO) 2021 Annual Meeting on Women’s Cancer in March 2021, and published in the New England Journal of Medicine in January 2022. The Society of Gynecologic Oncology (SGO) Annual Meeting on Women’s Cancer. In the multicenter, open-label, randomized, phase 3 Study 309/KEYNOTE-775, LEN + pembro demonstrated significant PFS and overall survival advantages. The approval is based on results from the pivotal Phase 3 Study 309/KEYNOTE-775 trial. The sNDA for pembrolizumab plus lenvatinib as treatment of advanced endometrial carcinoma was supported by data from the phase 3 Study-309/KEYNOTE-775 trial (NCT03517449). A multicenter, open label, randomized, phase 3 study to compare the efficacy and safety of lenvatinib in combination with pembrolizumab vs treatment of physician’s choice in patients with advanced endometrial cancer: study 309/KEYNOTE 775. The following dose modification recommendations have been adapted from the Study 309-KEYNOTE-775, the product information and consensus of the reference. (known as MSD outside the United States and Canada)’s KEYTRUDA ® (generic name: pembrolizumab) has been approved in Taiwan 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. In the phase 3 Study-309/KEYNOTE-775 trial, investigators compared the efficacy and safety of pembrolizumab and lenvatinib with physician’s choice of doxorubicin or paclitaxel following platinum. announced that LENVIMA ® (generic name: lenvatinib mesylate), the multiple receptor tyrosine kinase inhibitor discovered by Eisai, in combination with Merck & Co., Inc., Kenilworth, N.J., U.S.A.
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