NEW YORK – The European Medicines Agency's Committee for Medicinal Products for Human Use on Friday recommended approval of Bristol Myers Squibb's PD-1 inhibitor Opdivo (nivolumab) plus its CTLA-4 inhibitor Yervoy (ipilimumab) as a first-line treatment for patients with microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR) unresectable or metastatic colorectal cancer.
The committee's decision was informed by results from the Checkmate-8HW trial, in which more than 800 patients with MSI-H or dMMR advanced colorectal cancer were randomized to receive either Opdivo-Yervoy, Opdivo alone, or investigator's choice of chemotherapy in the first-line setting. There was a 79 percent reduction in the risk of disease progression or death for patients on Opdivo-Yervoy versus those on chemo. At a second interim analysis in September, the trial also demonstrated improved progression-free survival for patients on Opdivo-Yervoy versus Opdivo across all lines of therapy. BMS said in a statement that it will present data from that analysis at an upcoming medical conference.
The European Commission will factor in the CHMP's recommendation in deciding whether to grant market authorization to Opdivo-Yervoy in this setting. If approved, Opdivo-Yervoy would be the first dual checkpoint inhibitor therapy approved for treating first-line metastatic colorectal cancer, according to Dana Walker, BMS's VP and global program lead for gastrointestinal and genitourinary cancers.
The Opdivo-Yervoy combination is approved in the US and EU for treating metastatic MSI-H or dMMR colorectal cancer after prior fluoropyrimidine-based combination chemotherapy. Opdivo is also approved in the US as a monotherapy in this setting.