DESTINY-CRC01

NCT03384940 📎

Regimen

Experimental
Trastuzumab deruxtecan (T-DXd) 6.4 mg/kg Q3W
Control
single-arm (3 cohorts: IHC3+/ISH+, IHC2+/ISH−, IHC1+)

Population

HER2-expressing metastatic CRC, 3L+, RAS and BRAF wild-type; primary efficacy in HER2-positive cohort (IHC 3+ or IHC 2+/ISH+).

Key finding

Cohort A (HER2-positive, n=53): confirmed ORR 45.3% (95% CI 31.6–59.6); median follow-up 27.1 weeks; grade ≥3 AEs: neutropenia 22%, anaemia 14%; ILD/pneumonitis in 5 patients (6%): 2 grade 2, 1 grade 3, 2 grade 5 (treatment-related deaths); cohorts B and C: no responses.

Source: PMID 33961795

Timeline

    Guideline citations

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