Update of Phase III KEYFORM-007 trial of Keytruda (pembrolizumab)+ favezelimab in positive microsatellite stable (MSS) metastatic colorectal cancer
Merck ( known as MSD outside of the United States and Canada), announced that the Phase III KEYFORM-007 trial evaluating the investigational fixed-dose combination of favezelimab, Merck’s anti-LAG-3 antibody, and pembrolizumab (Keytruda ), Merck’s anti-PD-1 therapy, did not meet its primary endpoint of overall survival (OS) for the treatment of patients with previously treated PD-L1 positive microsatellite stable (MSS) metastatic colorectal cancer (mCRC).
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 (regorafenib or TAS-102 [trifluridine and tipiracil hydrochloride]). 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.
“Metastatic colorectal cancer continues to be a challenging disease to treat, especially for the majority of patients who have microsatellite stable disease, which has had limited response to immunotherapies,” said Dr. M. Catherine Pietanza, vice president, global clinical development, Merck Research Laboratories. “We are grateful to the patients and investigators for their participation in this study, and we will continue to advance our clinical development program to evaluate Keytruda-based combinations and novel candidates for patients with colorectal cancer in need of new options.”
In the U.S., Keytruda is approved for the treatment of patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer as determined by an FDA-approved test. Keytruda is not approved for the treatment of MSS mCRC.
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