Eisai Co. and Merck received approval from the FDA for the combination of Eisai’s LENVIMA, an orally available multiple receptor tyrosine kinase inhibitor, plus Merck’s KEYTRUDA, an anti-PD-1 therapy, for the treatment of advanced endometrial carcinoma that’s not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), who have disease progression following prior systemic therapy.

The approval is based on results from a Phase 3 Study in which LENVIMA plus KEYTRUDA demonstrated statistically significant improvements in overall survival (OS), reducing the risk of death by 32%, and progression-free survival (PFS), reducing the risk of disease progression or death by 40%, versus chemotherapy. LENVIMA plus KEYTRUDA also demonstrated statistically significant improvement in objective response rate (ORR), with an ORR of 30% versus 15% for patients who received chemotherapy alone, in addition to a complete response rate of 5% for KEYTRUDA plus LENVIMA versus 3% for chemotherapy and a partial response rate of 25% versus 13%, respectively.

"With a five-year survival rate of just 17%, 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," said Dr. Vicky Makker, principal investigator and medical oncologist, Memorial Sloan Kettering Cancer Center. "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."