Merck, known as MSD outside the United States and Canada, and Eisai announced that five-year data from the Phase 3 KEYNOTE-775/Study 309 trial confirmed a lasting survival benefit for KEYTRUDA plus LENVIMA compared to chemotherapy in advanced endometrial cancer patients. These findings were presented at the European Society of Medical Oncology (ESMO) Congress 2025.

The analysis indicated a continued overall survival benefit for the combination therapy, with no new safety concerns observed over five years.

This trial enrolled 827 patients with advanced endometrial carcinoma who had previously received platinum-based chemotherapy.

“Endometrial carcinoma remains challenging to treat in the recurrent or advanced setting, particularly for patients with mismatch repair proficient tumors, which are less responsive to immunotherapy alone,” said Dr. Vicky Makker, Principal Investigator and Gynecologic Medical Oncologist at Memorial Sloan Kettering Cancer Center.

“These five-year data from KEYNOTE-775/Study 309 demonstrate a sustained survival benefit with pembrolizumab plus lenvatinib, underscoring the combination’s important role as an effective treatment option for this patient population.”

“Recent advances have driven meaningful progress for patients with advanced endometrial carcinoma,” said Dr. Gregory Lubiniecki, Vice President, Global Clinical Development, Merck Research Laboratories. “The five-year results reinforce the durable survival benefit of KEYTRUDA plus LENVIMA and highlight our ongoing commitment to improving outcomes for patients with women’s cancers.”

This follow-up represents the longest data for an immunotherapy plus tyrosine kinase inhibitor combination in this patient group.

“The five-year follow-up from KEYNOTE-775/Study 309 represents the longest reported data for an immunotherapy plus tyrosine kinase inhibitor combination in advanced endometrial carcinoma,” said Dr. Corina Dutcus, Senior Vice President and Global Clinical Development Lead, Oncology, Eisai Inc. “These results further support the therapeutic value of this combination and reflect our shared dedication to advancing treatment options for women facing this disease.”

The combination is approved for advanced endometrial carcinoma that is pMMR or not MSI-H and has progressed after prior systemic therapy.