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Cited by 76Colorectal Cancer Treatments and StudiesHER2/EGFR in Cancer ResearchLung Cancer Treatments and Mutations

Trastuzumab deruxtecan (T-DXd) in patients (pts) with HER2-overexpressing/amplified (HER2+) metastatic colorectal cancer (mCRC): Primary results from the multicenter, randomized, phase 2 DESTINY-CRC02 study

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Raghav, Kanwal Pratap Singh, Siena, Salvatore, Takashima, Atsuo, Kato, Takeshi, Van Den Eynde, Marc, Di Bartolomeo, Maria, Komatsu, Yoshito, Kawakami, Hisato +12 more·2023·Journal of Clinical Oncology
DOI 10.1200/jco.2023.41.16_suppl.3501
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Abstract

3501 Background: T-DXd (6.4 mg/kg, every 3 weeks [Q3W]) demonstrated antitumor activity in pts with HER2+ mCRC in DESTINY-CRC01 (Siena et al. Lancet Oncol. 2021). We present primary results of DESTINY-CRC02 (NCT04744831), which assessed the efficacy and safety of T-DXd (5.4 and 6.4 mg/kg) in pts with HER2+ mCRC. Methods: This was a multicenter phase 2 study. Eligible pts had centrally confirmed HER2+ (immunohistochemistry [IHC] 3+ or IHC 2+/in situ hybridization [ISH]+) mCRC. Pts with RAS wild-type (wt) or mutant (m) mCRC were eligible. Pts had received prior standard therapy, unless contraindicated; prior anti-HER2 therapy was allowed. In stage 1, 80 pts were randomized 1:1 to 5.4 (n = 40) or 6.4 (n = 40) mg/kg T-DXd Q3W. In stage 2, an additional 42 pts received 5.4 mg/kg T-DXd. Primary endpoint was confirmed objective response rate (cORR) by blinded independent central review (BICR). Secondary endpoints included duration of response (DoR), progression-free survival (PFS), overall survival (OS), and safety. Results: At data cutoff (Nov 1, 2022), most pts in the 5.4 and 6.4 mg/kg T-DXd arms had HER2 IHC 3+ (78.0% and 85.0%), RAS wt tumors (82.9% and 85.0%), and a median of 3 and 4 prior lines of therapy, respectively. cORR was 37.8% (95% CI, 27.3-49.2%) in the 5.4 mg/kg arm and 27.5% (95% CI, 14.6-43.9%) in the 6.4 mg/kg arm (all partial responses in both arms). Key efficacy data are shown in the Table: Grade ≥3 treatment-emergent adverse events (AEs) were observed in 41/83 pts (49.4%) and 23/39 pts (59.0%) in the 5.4 and 6.4 mg/kg T-DXd arms, respectively. Serious AEs were observed in 20/83 pts (24.1%) and 12/39 pts (30.8%) in the 5.4 and 6.4 mg/kg arms, respectively. Independently adjudicated drug-related interstitial lung disease occurred in 7/83 pts (8.4%) with 5.4 mg/kg T-DXd and 5/39 pts (12.8%) with 6.4 mg/kg T-DXd, and most events were grade 1/2 (1 grade 5 in the 6.4 mg/kg arm). Conclusions: T-DXd showed promising antitumor activity in pts with HER2+ mCRC at both 5.4 and 6.4 mg/kg doses. Antitumor efficacy was observed irrespective of RAS mutation status at 5.4 mg/kg T-DXd, and in those with prior anti-HER2 therapy. Overall, safety was consistent with the known safety profile of T-DXd and favored the 5.4 mg/kg dose. Clinical trial information: NCT04744831 . [Table: see text]

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  • In the phase II DESTINY-CRC02 trial, the ORR for trastuzumab-deruxtecan-treated patients with advanced and pretreated metastatic colorectal cancer was 37.8% in the 5.4 mg/kg arm and 27.5% in the 6.4 mg/kg arm.

    “the ORR for T-DXd treated patients with advanced and pretreated mCRC was 37.8% in the 5.4 mg/kg arm and 27.5% in the 6.4 mg/kg arm.67”

    From Current and emerging concepts for systemic treatment of metastatic colorectal cancer (2025) · cites this paper as [67]

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Authors
Raghav, K. P. S., Siena, S., Takashima, A., Kato, T., Van Den Eynde, M., Di Bartolomeo, M., Komatsu, Y., Kawakami, H., Peeters, M., Andre, T., Lonardi, S., Yamaguchi, K., Tie, J., Gravalos Castro, C., Strickler, J. H., Barrios, D., Yan, Q., Kamio, T., Kobayashi, K., & Yoshino, T.
Affiliations
  • The University of Texas MD Anderson Cancer Center (US)
  • University of Milan (IT)
  • National Cancer Center Hospital (JP)
  • Osaka National Hospital (JP)
  • Cliniques Universitaires St-Luc, Brussels, Belgium
  • Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy
  • Hokkaido University Hospital (JP)
  • Kindai University Hospital (JP)
  • Antwerp University Hospital (BE)
  • Hôpital Saint-Antoine, Paris, France
  • Istituto Oncologico Veneto (IT)
  • The Cancer Institute Hospital (JP)
  • Peter MacCallum Cancer Centre (AU)
  • Hospital Universitario 12 de Octubre, Madrid, Spain
  • Duke Medical Center (US)
  • Daiichi Sankyo (United States) (US)
  • Daiichi-Sankyo (Japan) (JP)
  • National Cancer Center Hospital East (JP)
ORCID
Venue
Journal of Clinical Oncology
Publisher
American Society of Clinical Oncology (ASCO)
Published
2023-06-01
Volume
41
Issue
16_suppl
Pages
3501-3501
ISSN
  • 0732-183X (ISSN-L)
  • 1527-7755
DOI
10.1200/jco.2023.41.16_suppl.3501
OpenAlex
W4379330531
Cited by
75
References
0
Citations by year
2026: 11 · 2025: 18 · 2024: 34 · 2023: 12
Type
conference abstract
Language
en
Open access
Licence
other-oa
Locations
  • Journal of Clinical Oncology (publishedVersion)
  • Digital Access to Libraries (submittedVersion, other-oa)
  • Digital Access to Libraries (Université catholique de Louvain (UCL), l'Université de Namur (UNamur) and the Université Saint-Louis (USL-B)) (submittedVersion, other-oa)
Funders
Daiichi Sankyo, Inc and AstraZeneca
Topics
  • Health Sciences › Medicine › Oncology › Colorectal Cancer Treatments and Studies
  • Health Sciences › Medicine › Oncology › HER2/EGFR in Cancer Research
  • Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Treatments and Mutations
Keywords
trastuzumab deruxtecan, HER2 amplification, HER2 overexpression, dose comparison, objective response rate, RAS status, HER2-targeted therapy, treatment safety, immune-related adverse events, neurotoxicity, anticancer activity, progression-free survival, overall survival, duration of response

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