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DESTINY-CRC01

A Phase 2, Multicenter, Open-label Study of DS-8201a in Subjects With HER2-expressing Advanced Colorectal Cancer

Phase 2N = 78NCT03384940

Population
HER2-expressing metastatic colorectal cancer, RAS and BRAF V600E wild-type, progressed on two or more previous regimens
Design
Open-label, multicentre phase 2 study at 25 clinics and hospitals in Italy, Japan, Spain, the UK and the USA. Patients with centrally confirmed HER2-expressing metastatic colorectal cancer (RAS and BRAF V600E wild-type) that had progressed on two or more regimens received trastuzumab deruxtecan 6.4 mg/kg every 3 weeks. Patients were assigned to cohort A (HER2-positive: IHC 3+, or IHC 2+ and ISH-positive), B (IHC 2+ and ISH-negative) or C (IHC 1+); the primary endpoint was confirmed objective response rate in cohort A by independent central review.
Primary endpoint
ORR
Arms
  • Trastuzumab deruxtecan (experimental, n = 78): Trastuzumab deruxtecan 6.4 mg/kg every 3 weeks
People
Siena S
Show the numbers
Results reported for DESTINY-CRC01
EndpointAnalysisTrastuzumab deruxtecanControlEffect
ORRCohort A: HER2-positive tumours (IHC 3+, or IHC 2+ and ISH-positive), 53 patientsConfirmed objective response rate in cohort A by independent central review (primary endpoint)primarySiena 202145.3% (31.6–59.6%)—24 of 53 patients responded after a median follow-up of 27.1 weeks. Cohorts B (7 patients) and C (18 patients) are not reported in the abstract. Single-arm study.
Results reported for DESTINY-CRC01
EndpointAnalysisTrastuzumab deruxtecanControlEffect
ORRCohort A: HER2-positive tumours (IHC 3+, or IHC 2+ and ISH-positive), 53 patientsConfirmed objective response rate in cohort A by independent central review (primary endpoint)primarySiena 202145.3% (31.6–59.6%)—24 of 53 patients responded after a median follow-up of 27.1 weeks. Cohorts B (7 patients) and C (18 patients) are not reported in the abstract. Single-arm study.
Primary publication: Siena S, Di Bartolomeo M, Raghav K, Masuishi T, Loupakis F, Kawakami H, et al. Trastuzumab deruxtecan (DS-8201) in patients with HER2-expressing metastatic colorectal cancer (DESTINY-CRC01): a multicentre, open-label, phase 2 trial. Lancet Oncol. 2021;22(6):779-789. PubMedDOI

Appears in

Sources

  1. Siena S, Di Bartolomeo M, Raghav K, Masuishi T, Loupakis F, Kawakami H, et al. Trastuzumab deruxtecan (DS-8201) in patients with HER2-expressing metastatic colorectal cancer (DESTINY-CRC01): a multicentre, open-label, phase 2 trial. Lancet Oncol. 2021;22(6):779-789.

    PubMedDOI