Merck, Eisai Announce Disappointing Results From Phase 3 LEAP-003 And LEAP-017 Trials

(RTTNews) - Merck (MRK) and Eisai Co., Ltd. announced that Phase 3 LEAP-003 trial and LEAP-017 trial failed to meet endpoint of overall survival (OS).

The companies stated that Phase 3 LEAP-003 trial evaluating KEYTRUDA plus LENVIMA for the first-line treatment of adults with unresectable or metastatic melanoma did not demonstrate an improvement in overall survival (OS), versus KEYTRUDA alone. The company said that it will discontinuing the study based on the recommendation of an independent Data Monitoring Committee (DMC), which reviewed data from a planned interim analysis.

The Phase 3 LEAP-017 trial evaluating KEYTRUDA plus LENVIMA did not meet its primary endpoint of OS for patients with unresectable and metastatic colorectal cancer that is mismatch repair proficient (pMMR) or not microsatellite instability-high (MSI-H) who experienced disease progression on, or became intolerant to, prior therapy.

The company specified that both the LEAP-003 and LEAP-017 trials, the safety profile of KEYTRUDA plus LENVIMA was consistent with previously reported data on the combination.

A full evaluation of the data from these studies, including pre-planned key subgroup analyses, is ongoing. The companies said it will work with investigators to share the results with the scientific community.