Phase 3 colorectal cancer trial misses survival endpoint
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A randomized phase 3 trial designed to compare an investigational combination with standard care for certain patients with advanced colorectal cancer failed to meet its primary endpoint of OS.
The KEYFORM-007 trial included 441 patients with previously treated PD-L1-positive, microsatellite stable metastatic colorectal cancer.
Researchers assigned half of the patients to a fixed-dose combination of 800 mg favezelimab (MK-4280, Merck) — an investigational anti-lymphocyte activation gene-3 antibody that aims to restore T cell effector function — in combination with 200 mg pembrolizumab (Keytruda, Merck), an anti-PD-1 therapy, on day 1 and then every 3 weeks for 35 cycles.
The other half of patients received investigator’s choice of regorafenib (Stivarga, Bayer) or trifluridine/tipiracil (Lonsurf; Taiho Oncology, Servier).
OS served as the primary endpoint. Key secondary endpoints included PFS, objective response rate, duration of response, safety and quality of life.
Results of the final prespecified analysis showed no OS improvement with the experimental combination compared with standard care.
The combination exhibited a safety profile consistent with prior reports of each agent. Investigators observed no new safety signals.
“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,” M. Catherine Pietanza, MD, vice president of global clinical development at Merck, said in a press release. “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.”
Complete data from KEYFORM-007 will be presented at a medical meeting.
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