By Fineline Cube 
Bristol-Myers Squibb (BMS, NYSE: BMY) announced this week that the US Food and Drug Administration (FDA) has approved its combination therapy of Opdivo (nivolumab) and Yervoy (ipilimumab) for the first-line treatment of adult and pediatric patients (12 years and older) with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (CRC). This approval follows the Breakthrough Therapy Designation and Priority Review status granted by the FDA.
Clinical Trial Results
The approval is based on results from the CheckMate-8HW trial, the largest Phase III study evaluating immunotherapy in patients with MSI-H/dMMR mCRC. The trial compared Opdivo plus Yervoy (n=354) against Opdivo monotherapy (n=353) across all lines of therapy and against investigator’s choice chemotherapy (n=101) in the first-line setting. The combination therapy demonstrated significant improvements in progression-free survival (PFS) as assessed by Blinded Independent Central Review (BICR), meeting the dual primary endpoints.
Therapeutic Impact
This approval underscores the potential of Opdivo plus Yervoy to significantly improve treatment outcomes for patients with MSI-H/dMMR CRC, offering a new standard of care in both adult and pediatric populations. The combination therapy provides a robust alternative to traditional chemotherapy, leveraging the dual immune checkpoint inhibition mechanism to enhance antitumor activity.-Fineline Info & Tech