Merck’s Phase 3 KEYFORM-007 trial tested the efficacy of a fixed-dose combination of favezelimab and pembrolizumab in treating PD-L1-positive microsatellite-stable metastatic colorectal cancer (mCRC). The trial failed to meet its primary endpoint of improved overall survival (OS) compared to the standard of care (regorafenib or TAS-102).
The safety profile of the combination was consistent with previous studies, with no new concerns identified. Merck will continue to analyze the data and share the results with researchers.
Despite the negative outcome of KEYFORM-007, Merck remains committed to exploring KEYTRUDA-based combinations and other novel candidates for patients with colorectal cancer who have limited treatment options. KEYTRUDA is currently approved in the U.S. for treating microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer but not for MSS mCRC.
The fixed-dose combination of favezelimab and pembrolizumab is also being investigated in other cancer types, including certain hematologic malignancies and solid tumors. Notable ongoing trials include KEYFORM-008, which evaluates the combination in patients with relapsed or refractory classical Hodgkin lymphoma.
Colorectal cancer remains a significant health concern, ranking as the third most commonly diagnosed and second most common cause of cancer-related deaths globally. Early detection and screening are crucial to improve outcomes.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Ferry, a computer data scientist, focuses on the latest clinical trial industry news and trends.
