Merck, Eisai colorectal cancer study did not meet statistical significance

Merck (MRK) and Eisai (ESALY) provided updates on two Phase 3 trials, LEAP-003 and LEAP-017 investigating Keytruda plus Lenvima. The Phase 3 LEAP-017 trial evaluating Keytruda plus Lenvima did not meet its primary endpoint of overall survival for the treatment of patients with unresectable and metastatic colorectal cancer that is mismatch repair proficient or not microsatellite instability-high who experienced disease progression on, or became intolerant to, prior therapy. In the final pre-specified analysis of overall survival, a trend toward improvement was observed with Keytruda plus Lenvima versus regorafenib or TAS-102. However, the 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 progression-free survival, objective response rate and duration of response with Keytruda plus Lenvima versus regorafenib or TAS-102; however, per the pre-specified statistical analysis plan the results were not tested for statistical significance, the companies said in a statement.