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CHMP Recommends Approval of Opdivo® Plus Yervoy® for First-Line Treatment of MSI-H/dMMR Metastatic Colorectal Cancer

NextEdge Admin

17 Nov 2024

2 min 11 sec

Immune checkpoint inhibitor,colorectal cancer,Oncology

Bristol Myers Squibb announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval of Opdivo® (nivolumab) plus Yervoy® (ipilimumab) for first-line treatment of adult patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) unresectable or metastatic colorectal cancer (mCRC). This marks the first dual checkpoint inhibitor therapy for this indication, addressing a critical need in a population where 5-7% of metastatic colorectal cancer patients have dMMR or MSI-H tumors.

The recommendation is based on the CheckMate -8HW trial, which demonstrated a 79% reduction in the risk of disease progression or death compared to chemotherapy (HR: 0.21; 95% CI: 0.14-0.32; p<0.0001). The trial highlighted significant improvement in progression-free survival (PFS) as assessed by Blinded Independent Central Review, with a manageable safety profile consistent with previous data.

Dana Walker, M.D., M.S.C.E., vice president at Bristol Myers Squibb, emphasized the transformative potential of this dual immunotherapy in improving outcomes for patients in the European Union. The European Commission will now review CHMP’s recommendation for final approval.

Results from CheckMate -8HW have been presented at key medical congresses, underscoring the clinical significance of Opdivo plus Yervoy in this patient group. The study continues to evaluate secondary endpoints, including overall survival (OS). Bristol Myers Squibb expressed gratitude to the patients and investigators involved in the trial.