Results from pivotal phase III KEYNOTE-775/Study 309 trial of Keytruda and Lenvima in advanced endometrial carcinoma.

The pivotal study evaluated the combination of Lenvima, plus Keytruda, from Merck Inc., versus chemotherapy (treatment of physician’s choice of doxorubicin or paclitaxel) for patients with advanced endometrial carcinoma following at-least oneprior 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. 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 rate (ORR) data and additional detailed efficacy and safety data, including subgroup analyses, are also featured in the publication.

Based on the results from the Phase III Study 309/KEYNOTE-775 trial, Lenvima plus Keytruda has been approved in the U.S. for patients with advanced endometrial carcinoma that is not microsatellite instability-high or dMMR, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation. Lenvima plus Keytruda is also approved in the European Union and Japan for certain patients with advanced or recurrent endometrial carcinoma regardless of mismatch repair status. Eisai and Merck & Co., Inc., are studying the Lenvima plus Keytruda combination through the LEAP (LEnvatinib And Pembrolizumab) clinical program in more than 10 different tumor types across more than 20 clinical trials.