DESTINY-CRC02

NCT04744831 📎

Regimen

Experimental
Trastuzumab deruxtecan (T-DXd) 5.4 mg/kg Q3W or 6.4 mg/kg Q3W
Control
single-arm (two dose cohorts)

Population

HER2-positive (IHC 3+ or IHC 2+/ISH+) metastatic CRC, 2L+, RAS wild-type or mutant; prior chemotherapy required.

Key finding

5.4 mg/kg arm (n=82): ORR by BICR 37.8% (95% CI 27.3–49.2); 6.4 mg/kg arm (n=40): ORR 27.5% (14.6–43.9); activity seen in RAS-mutant and prior anti-HER2-exposed subgroups; grade ≥3 drug-related AEs: 41% (5.4 mg/kg) vs 49% (6.4 mg/kg); ILD events: 8% (5.4 mg/kg, all grade 1–2) vs 13% (6.4 mg/kg, 1 grade 5); 1 treatment-related death (hepatic failure, 5.4 mg/kg arm).

Source: PMID 39116902

Timeline

    Guideline citations

    • NCCN Colon (p.60)
    • NCCN Rectal (p.77)