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Trastuzumab-deruxtecan monotherapy (DESTINY-CRC01, HER2+ mCRC)

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ComponentsDRUG-TRASTUZUMAB-DERUXTECAN
IDREG-TRASTUZUMAB-DERUXTECAN-CRC
TypeRegimen
Statusreviewed 2026-04-27 | pending_clinical_signoff
DiseasesNone declared
SourcesSRC-ESMO-COLON-2024 SRC-NCCN-COLON-2025

Notes

DESTINY-CRC01 Phase II (2021): HER2-amp RAS-WT chemo-refractory mCRC (median 4 prior lines), ORR 45% in IHC 3+/IHC 2+ ISH+ cohort, mPFS 6.9 mo, mOS 15.5 mo. T-DXd is an ADC: trastuzumab + cleavable linker + DXd (DNA topo-I inhibitor exatecan derivative). Bystander effect benefits HER2-heterogeneous tumors. ILD/pneumonitis is the dominant safety signal (~6% all-grade, ~3% Grade ≥3) — baseline + serial lung imaging mandatory. CRC dose 6.4 mg/kg differs from breast/gastric 5.4 mg/kg (DESTINY-CRC01 protocol).

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