BMS Reports the EC’s Approval of Opdivo (Nivolumab) Plus Yervoy (Ipilimumab) as a 1L Treatment of MSI-H/dMMR Metastatic Colorectal Cancer (mCRC)
Shots:
- The EC has approved Opdivo + Yervoy as a 1L treatment of MSI-H/dMMR unresectable mCRC, applicable across whole EU plus Iceland, Liechtenstein & Norway, based on P-III (CheckMate -8HW) study
- The P-III study assessed Opdivo (240mg, followed by 480mg, Q4W) + Yervoy (1mg/kg, Q3W, 4 doses) vs Opdivo monotx. (240mg, Q2W, 6 doses, followed by 480mg, Q4W) or CT (mFOLFOX-6/FOLFIRI ± bevacizumab/cetuximab) in MSI-H/dMMR mCRC patients (n=839)
- Study, at ~31.5mos. follow-up, showed a 79% reduction in the disease progression or death risk, with mPFS not achieved vs 5.9mos. PFS benefit was consistent across all subgroups, incl. KRAS/NRAS mutations & baseline liver, lung or peritoneal metastases
Ref: BMS | Image: BMS
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