Biopharmaceutical company Bristol Myers Squibb (NYSE: BMY) announced on Monday that it has received European Commission approval for the combination of Opdivo (nivolumab) and Yervoy (ipilimumab) as a first-line treatment for adults with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (mCRC). This marks the first dual checkpoint inhibitor approved in the European Union for this indication.

This approval is based on results from the Phase 3 CheckMate -8HW trial, which showed the combination reduced the risk of disease progression or death by 79% compared to chemotherapy. Median progression-free survival (PFS) was not reached in the Opdivo plus Yervoy arm, significantly outperforming the median PFS of 5.9 months in the chemotherapy group.

The dual therapy demonstrated consistent benefits across subgroups, including patients with mutations or metastases in the liver, lung, or peritoneum. Safety profiles were manageable, aligning with previous data.

Mismatch repair deficiency and microsatellite instability, present in 5-7% of metastatic CRC patients, are linked to poor outcomes with conventional chemotherapy. Opdivo and Yervoy's innovative mechanism of harnessing the immune system offers new hope for this challenging subset of patients.

Bristol Myers Squibb continues to advance its Immuno-Oncology portfolio, with Opdivo and Yervoy approved for multiple cancer types globally. Both therapies exemplify the company's commitment to developing groundbreaking treatments that improve outcomes for cancer patients.