BMS Reports the US FDA’s Approval of Opdivo + Yervoy as a 1L Treatment of MSI-H/dMMR Metastatic Colorectal Cancer (mCRC)
Shots:
- The US FDA has approved Opdivo + Yervoy for 1L treatment of MSI-H/dMMR unresectable mCRC pts (≥12yrs.) based on P-III (CheckMate-8HW) study assessing Opdivo + Yervoy vs Opdivo alone or CT in 839 pts (Approved before PDUFA: Jun 23, 2025)
- Regimen vs Opdivo monotx. showed 38% PFS (mPFS: not reached (NR) vs 39.3mos) in all-lines setting, with superior 12, 24, & 36mos. PFS rates (76% vs 63%, 71% vs 56%, 68% vs 51%); KM curve depicted early separation at 2mos. sustained through 3yrs & ORR per BICR was 71% vs 58%
- Regimen vs CT showed PFS of 79% (mPFS: NR vs 5.8mos) in 1L setting, with superior PFS rates at 12 & 24mos. (79% vs 21% & 72% vs 14%). KM curves depicted early separation at 3mos. sustained through 2yrs.
Ref: BMS | Image: BMS
Related News:- BMS’ Opdivo Receives the CHMP’s Positive Opinion as a Neoadjuvant Treatment of Resectable NSCLC
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