Dr. Catherine Pietanza, VP of Merck’s clinical global development, acknowledges that metastatic colorectal cancer has been a difficult illness to effectively treat. This holds true for patients living with microsatellite stable disease with its limited response to immunotherapy regimens.
KEYFORM-007
The KEYFORM-007 phase 3 randomized trial enrolled 441 patients who were diagnosed with advanced colorectal cancer. The patients had been treated for PD-L1-positive, microsatellite stable metastatic colorectal cancer. The investigational combination was compared against the standard of care for colorectal cancer patients. However, the trial did not meet its goal of overall survival (OS).
The new investigational combination was compared against the standard of care for patients with colorectal cancer. Half the patients were assigned a fixed dose combination of Merck’s favezelimab that is designed to revive T cell effector function. These patients were to receive 200 mg pembrolizumab, defined as an anti-PD-1 therapy to be administered on day one followed every three weeks for 35 cycles.
The remaining half of the group were administered the investigator’s choice. The main endpoint was overall survival. Secondary endpoints were progression free survival, duration of response, objective response rate, quality of life and safety. Final results of the trial did not show an improvement in overall survival with the experimental combination in comparison to standard of care.
The safety profile for the combination was consistent with previous reports.
Dr. Pietanza expressed the researchers’ gratitude for patients’ participation in the study and agreed to continue advancing their program of clinical development evaluating Keytruda-based combinations to treat colorectal patients with unmet needs.
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Last modified: November 4, 2024
