Bristol Myers Squibb (NYSE: BMY) today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending the approval of Opdivo® (nivolumab) in combination with Yervoy® (ipilimumab) for the first-line treatment of adult patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) unresectable or metastatic colorectal cancer (mCRC). The recommendation follows results from the CheckMate -8HW trial, which showed a 79% reduction in the risk of disease progression or death (HR: 0.21; 95% CI: 0.14-0.32; p<0.0001) when compared to chemotherapy. The European Commission (EC) will now review the CHMP recommendation and make a final decision.
According to Dr. Dana Walker, Vice President of Global Program Lead for Gastrointestinal and Genitourinary Cancers at Bristol Myers Squibb, “This is the first dual checkpoint inhibitor treatment for first-line metastatic colorectal cancer, delivering a transformative benefit for MSI-H/dMMR patients. We look forward to the EC’s upcoming decision.”
The positive opinion was supported by data from the CheckMate -8HW trial, which demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) with Opdivo plus Yervoy compared to chemotherapy. The safety profile of the dual immunotherapy combination was consistent with previous findings, with no new safety signals identified.
In addition, the combination showed a significant improvement in PFS compared to Opdivo monotherapy in patients across all lines of therapy, with ongoing studies assessing secondary endpoints, including overall survival.
About the CheckMate -8HW Trial
CheckMate -8HW (NCT04008030) is a Phase 3 trial evaluating Opdivo plus Yervoy versus Opdivo monotherapy or chemotherapy in patients with MSI-H or dMMR metastatic colorectal cancer. The trial includes 839 patients and has demonstrated the efficacy of the dual immunotherapy regimen in the first-line treatment setting, with further analysis ongoing.
About MSI-H/dMMR Colorectal Cancer
Approximately 5-7% of metastatic colorectal cancer patients have MSI-H or dMMR tumors, which typically have a poorer prognosis and do not respond well to traditional chemotherapy. These patients may benefit from immunotherapy, which harnesses the body’s immune system to fight cancer.
About Opdivo and Yervoy
Opdivo is a PD-1 immune checkpoint inhibitor designed to help the body’s immune system recognize and attack cancer cells. Yervoy is a CTLA-4 inhibitor that enhances immune activity by blocking negative regulators of T-cell function. Both therapies have shown efficacy across multiple cancers and are approved in various countries worldwide.
Bristol Myers Squibb remains committed to advancing cancer care with innovative therapies, and the positive opinion for Opdivo plus Yervoy represents a significant milestone in providing new treatment options for patients with MSI-H/dMMR metastatic colorectal cancer.
