The phase III KEYNOTE-177 trial evaluating first-line treatment of Keytruda in patients with microsatellite instability-high or mismatch repair deficient unresectable or metastatic colorectal cancer met one of its dual primary endpoints of progression-free survival.
Merck sponsors Keytruda.
Based on an interim analysis conducted by an independent data monitoring committee, Keytruda monotherapy demonstrated a statistically significant and clinically meaningful improvement in PFS compared with chemotherapy (investigator’s choice of mFOLFOX6 or FOLFIRI, with or without bevacizumab or cetuximab). Based on the committee’s recommendation, the study will continue without changes to evaluate overall survival, the other dual primary endpoint. The safety profile of Keytruda in this trial was consistent with previously reported studies, and no new safety signals were identified.
“These head-to-head data with Keytruda are the first time a single-agent, anti-cancer therapy, and particularly an anti-PD-1 monotherapy, achieved a statistically significant improvement in progression-free survival over chemotherapy, including the current standard of care regimen of mFOLFOX6 plus bevacizumab, in patients with MSI-H colorectal cancer,” Roy Baynes, senior vice president and head of global clinical development, and chief medical officer of Merck Research Laboratories, said in a statement.
In May 2017, Keytruda became the first cancer therapy approved by FDA for use based on a biomarker, regardless of tumor type, in previously treated patients with MSI-H or dMMR solid tumors.
