Benzinga | Jan 20, 2022 06:58AM EST

Results From Pivotal Phase 3 KEYNOTE-775/Study 309 Trial Of KEYTRUDA Plus LENVIMA In Advanced Endometrial Carcinoma Published In The New England Journal of Medicine

Merck (NYSE:MRK), known as MSD outside the United States and Canada, and Eisai today announced the publication of results from the Phase 3 KEYNOTE-775/Study 309 trial in the January 19, 2022 edition of the New England Journal of Medicine. The pivotal study evaluated the combination of KEYTRUDA, Merck's anti-PD-1 therapy, plus LENVIMA, the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai, 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.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220120005102/en/

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 (see news release from SGO 2021 here). Results showed that the KEYTRUDA plus LENVIMA 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.

"While rates of endometrial carcinoma continue to rise globally, patients with advanced or recurrent disease have limited options available to them once the disease progresses following platinum-based chemotherapy," said Dr. Gregory Lubiniecki, Vice President, Oncology Clinical Research, Merck Research Laboratories. "KEYNOTE-775/Study 309 is an important Phase 3 study that supported recent approvals of KEYTRUDA plus LENVIMA for certain types of advanced endometrial carcinoma in the U.S. and other countries around the world, where it became the first immunotherapy and tyrosine kinase inhibitor combination approved for these patients."

"The Phase 3 KEYNOTE-775/Study 309 trial demonstrates the ongoing commitment that Eisai and Merck share in addressing the unmet needs of people living with difficult-to-treat cancers, including advanced endometrial carcinoma," said Corina Dutcus, M.D., Senior Vice President, Clinical Research, Oncology Business Group at Eisai Inc. "The publication of this study in the New England Journal of Medicine reflects the importance of our joint research in exploring the potential of the KEYTRUDA plus LENVIMA combination."

The publication contains results for the all-comer population, including the mismatch repair deficient (dMMR) patient population for which KEYTRUDA plus LENVIMA is not approved in the U.S.

Based on the results from the Phase 3 KEYNOTE-775/Study 309 trial, KEYTRUDA plus LENVIMA 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. KEYTRUDA plus LENVIMA is also approved in the European Union and Japan for certain patients with advanced or recurrent endometrial carcinoma regardless of mismatch repair status. Merck and Eisai are studying the KEYTRUDA plus LENVIMA combination through the LEAP (LEnvatinib And Pembrolizumab) clinical program in more than 10 different tumor types across more than 20 clinical trials.