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BMS Reports the EC’s Approval of Opdivo (Nivolumab) Plus Yervoy (Ipilimumab) as a 1L Treatment of MSI-H/dMMR Metastatic Colorectal Cancer (mCRC)

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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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Disha Nankani

Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.

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