CODEBREAK-300

NCT05198934 📎

Regimen

Experimental
Sotorasib 960 mg QD + panitumumab; or sotorasib 240 mg QD + panitumumab
Control
Investigator's choice chemotherapy (trifluridine/tipiracil or regorafenib)

Population

KRAS G12C-mutant chemorefractory metastatic CRC, 3L+ (≥2 prior lines).

Key finding

960mg sotorasib+panitumumab vs standard care: median PFS 5.6 vs 2.2 months (HR 0.49, 95% CI 0.30–0.80; P=0.006); ORR 26.4% (15.3–40.3) vs 0% (0–6.6); 240mg sotorasib+panitu vs standard: PFS HR 0.58 (0.36–0.93; P=0.03), ORR 5.7%; grade ≥3 TRAEs: 35.8% (960mg), 30.2% (240mg), 43.1% (control); skin toxicity and hypomagnesemia most common.

Source: PMID 37870968

Timeline

    Guideline citations

    • NCCN Colon (p.20)
    • NCCN Rectal (p.26)