Merck reports Phase 3 KEYFORM-007 trial did not meet primary endpoint

Merck announced that the Phase 3 KEYFORM-007 trial evaluating the investigational fixed-dose combination of favezelimab, Merck’s anti-LAG-3 antibody, and pembrolizumab, or KEYTRUDA, Merck’s anti-PD-1 therapy, did not meet its primary endpoint of overall survival, or OS, for the treatment of patients with previously treated PD-L1 positive microsatellite stable, or MSS, metastatic colorectal cancer. At the final pre-specified analysis, the favezelimab and pembrolizumab fixed-dose combination did not demonstrate an improvement in OS compared to standard of care. The safety profile of the fixed-dose combination was consistent with that observed for favezelimab and pembrolizumab in previously reported studies, with no new safety signals observed. A full evaluation of the data is ongoing and Merck will work with investigators to share the results with the scientific community. In the U.S., KEYTRUDA is approved for the treatment of patients with unresectable or metastatic microsatellite instability-high or mismatch repair deficient colorectal cancer as determined by an FDA-approved test. KEYTRUDA is not approved for the treatment of MSS mCRC.