NEW YORK – The European Medicines Agency's Committee for Medicinal Products for Human Use, or CHMP, on Friday recommended Bristol Myers Squibb's nivolumab (Opdivo) plus ipilimumab (Yervoy) to treat mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-high) metastatic colorectal cancer.
The CHMP opinion was based on data from the Phase II CheckMate-142 trial. In that study, 119 metastatic colorectal cancer patients previously treated with fluoropyrimidine, oxaliplatin, and irinotecan received the nivolumab-ipilimumab combination, and 55 percent had an objective response and 84 percent achieved disease control at one year. Progression-free survival was 76 percent at nine months and 71 percent at 12 months; overall survival was 87 percent at nine months and 85 percent at one year.
The European Commission will review CHMP's recommendation and issue a decision later this year.
"Metastatic colorectal cancers with mismatch repair deficient or microsatellite instability-high biomarkers can be difficult to treat, and patients who progress on or after first-line chemotherapy still face a great unmet need despite overall progress in the field," Ian Waxman, development lead for gastrointestinal cancers at BMS, said in a statement. "The CHMP's positive opinion further supports our goal to advance rational combinations that target distinct but complementary immune pathways."
The US Food and Drug Administration granted accelerated approval to the nivolumab-ipilimumab combination for this same indication in 2018.
In January, the EC approved pembrolizumab (Merck's Keytruda) as a first-line therapy for MSI-high and dMMR metastatic colorectal cancer.