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FDA Grants Full Approval to Merck, Eisai's Keytruda, Lenvima Combo in Endometrial Cancer

NEW YORK – Merck and Eisai on Thursday said that the US Food and Drug Administration has granted full approval to the combination of Merck's checkpoint inhibitor pembrolizumab (Keytruda) and Eisai's tyrosine kinase inhibitor lenvatinib (Lenvima) for advanced endometrial cancer patients who don't have microsatellite instability-high or mismatch repair deficient tumors, have progressed on systemic therapy, and can't receive surgery or radiation.

The FDA granted accelerated approval to this combination in 2019, based on objective response rates from the single-arm Keynote-146 study. Continued approval of the indication was contingent on the sponsors showing benefit in pivotal studies.

Merck and Eisai were able to show that within the Phase III Keynote-775 trial advanced endometrial cancer patients on pembrolizumab-lenvatinib had a 32 percent lower risk of death and progression-free survival and a 40 percent lower risk of disease progression or death, compared to those on chemotherapy (either doxorubicin or paclitaxel). In the pembrolizumab-lenvatinib arm, 30 percent of patients saw an objective response, compared to 15 percent of patients on chemo.

"With a five-year survival rate of just 17 percent, women with advanced endometrial cancer who are not candidates for curative therapy, particularly those with disease progression following prior systemic therapy, have limited treatment options," Vicky Makker, principal investigator of Keynote-775 and a medical oncologist at Memorial Sloan Kettering, said in a statement. "This approval is an important step forward in helping patients fight this difficult-to-treat malignancy, as physicians can now provide an option that may improve survival outcomes."