Phase III LEAP-017 trial of Keytruda + Lenvima fails to meet primary endpoint in colorectal cancer

Merck Inc and Eisai provided updates on the Phase III LEAP-017 trial investigating Keytruda (pembrolizumab) injection, 100 mg, Merck’s anti-PD-1 therapy, plus Lenvima (lenvatinib), the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai. In the Phase III LEAP-017 trial evaluating Keytruda plus Lenvima did not meet its primary endpoint of OS for the treatment of 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.

In the final pre-specified analysis of OS, a trend toward improvement was observed with Keytruda plus Lenvima versus regorafenib or TAS-102 (trifluridine and tipiracil hydrochloride); however, these results did not meet statistical significance per the pre-specified statistical analysis plan. A trend toward improvement was also observed in key secondary endpoints of PFS, objective response rate (ORR) and duration of response (DOR) with Keytruda plus Lenvima versus regorafenib or TAS-102; however, per the pre-specified statistical analysis plan these results were not tested for statistical significance.

In the LEAP-017 trial, the safety profile of Keytruda plus Lenvima was consistent with previously reported data on the combination. A full evaluation of the data from the study, including pre-planned key subgroup analyses, is ongoing. The companies will work with investigators to share the results with the scientific community.