Merck Says Phase 3 LEAP-001 Trial Evaluating KEYTRUDA Plus LENVIMA Did Not Meet Endpoints

(RTTNews) - Merck & Co., Inc. (MRK), known as MSD outside of the U.S. and Canada, and Japan's Eisai Co. Ltd. (ESALY.PK, ESALF.PK) announced Friday that the Phase 3 LEAP-001 trial evaluating KEYTRUDA, Merck's anti-PD-1 therapy, plus LENVIMA did not meet its dual primary endpoints of overall survival (OS) and progression-free survival (PFS) for the first-line treatment of patients with advanced or recurrent endometrial carcinoma whose disease is mismatch repair proficient (pMMR)/not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR)/MSI-H.

LENVIMA is the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai.

At the final analysis, KEYTRUDA plus LENVIMA did not improve OS or PFS sufficiently to meet the study's prespecified statistical criteria in the first-line treatment of certain patients with advanced or recurrent endometrial carcinoma versus a standard of care, platinum-based chemotherapy doublet (carboplatin plus paclitaxel).

The safety profile of KEYTRUDA plus LENVIMA was consistent with that observed in previously reported studies evaluating the combination.

Results from the LEAP-001 trial do not affect the current approved indications for the KEYTRUDA plus LENVIMA combination or other ongoing trials from the LEAP clinical program.