CODEBREAK-100-PANC

NCT03600883 📎

Regimen

Experimental
Sotorasib (AMG 510) 960 mg PO QD continuous
Control
single-arm / no comparator (historical 2L PDAC ORR <10%, mOS 5-7 mo)

Population

Previously treated (≥1 prior line) locally advanced or metastatic PDAC with KRAS p.G12C mutation (rare, ~1-2% of PDAC); 38 evaluable PDAC pts across phase 1 + 2 of CodeBreaK-100 (Strickler NEJM 2023).

Key finding

Second KRAS G12C inhibitor to demonstrate single-agent activity in previously treated KRAS G12C PDAC (NEJM 2023). ORR 21% + DCR 84% vs single-digit chemo benchmark confirmed the class effect first seen with adagrasib. Toxicity was mostly low-grade (diarrhea, fatigue). Confirmed that biomarker-matched KRAS G12C therapy is active across pan-tumor settings including PDAC.

Source: PMID 36546651

Timeline

    Guideline citations

    • NCCN PANCREATIC (p.98)