NEW YORK – Bristol Myers Squibb on Monday said the European Commission approved its PD-1 inhibitor Opdivo (nivolumab) plus the CTLA-4 inhibitor Yervoy (ipilimumab) as a first-line treatment for microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR) unresectable or metastatic colorectal cancer.
The commission based its decision on results from the Phase III CheckMate-8HW trial in which patients on Opdivo and Yervoy had a statistically significant and clinically meaningful improvement in progression-free survival and a 79 percent reduced risk of disease progression or death, compared to investigator's choice of chemotherapy.
About 5 percent to 7 percent of patients with metastatic colorectal cancer have dMMR or MSI-H tumors, and they typically have a poor prognosis and are less likely to benefit from standard chemotherapy.
The approval for the Opdivo-Yervoy combination follows a positive recommendation from the European Medicines Agency's Committee for Medicinal Products for Human Use in November. The drug combo is the first dual checkpoint inhibitor therapy approved in the EU for first-line metastatic MSI-H or dMMR colorectal cancer. It is already approved in the US and the EU for metastatic MSI-H or dMMR colorectal cancer after prior fluoropyrimidine-based combination chemotherapy.