HER2-related biomarkers predict clinical outcomes with trastuzumab deruxtecan treatment in patients with HER2-expressing metastatic colorectal cancer: biomarker analyses of DESTINY-CRC01

Salvatore Siena (), Kanwal Raghav, Toshiki Masuishi, Kensei Yamaguchi, Tomohiro Nishina, Elena Elez, Javier Rodriguez, Ian Chau, Maria Bartolomeo, Hisato Kawakami, Fumitaka Suto, Makito Koga, Koichiro Inaki, Yusuke Kuwahara, Issey Takehara, Daniel Barrios, Kojiro Kobayashi, Axel Grothey and Takayuki Yoshino
Additional contact information
Salvatore Siena: Grande Ospedale Metropolitano Niguarda
Kanwal Raghav: The University of Texas MD Anderson Cancer Center
Toshiki Masuishi: Aichi Cancer Center Hospital
Kensei Yamaguchi: The Cancer Institute Hospital of JFCR
Tomohiro Nishina: National Hospital Organization Shikoku Cancer Center
Elena Elez: Universitat Autònoma de Barcelona
Javier Rodriguez: Clinica Universidad de Navarra
Ian Chau: Royal Marsden NHS Foundation Trust
Maria Bartolomeo: Fondazione IRCCS Istituto Nazionale Tumori
Hisato Kawakami: Kindai University Hospital
Fumitaka Suto: Daiichi Sankyo
Makito Koga: Ltd
Koichiro Inaki: Ltd
Yusuke Kuwahara: Daiichi Sankyo
Issey Takehara: Ltd
Daniel Barrios: Daiichi Sankyo
Kojiro Kobayashi: Daiichi Sankyo
Axel Grothey: West Cancer Center
Takayuki Yoshino: National Cancer Center Hospital East

Nature Communications, 2024, vol. 15, issue 1, 1-12

Abstract: Abstract DESTINY-CRC01 (NCT03384940) was a multicentre, open-label, phase 2 study that investigated the safety and efficacy of trastuzumab deruxtecan (T-DXd) in patients with human epidermal growth factor receptor 2 (HER2)-expressing metastatic colorectal cancer (CRC). The present exploratory biomarker analysis aims to investigate relationships between biomarkers and clinical outcomes in patients with HER2-positive (immunohistochemistry [IHC] 3+ or IHC 2+ and in situ hybridization [ISH] positive) Cohort A (N = 53) of DESTINY-CRC01. Higher levels of HER2 biomarkers in baseline tissue and liquid biopsies, including HER2 status (IHC/ISH), HER2/CEP17 ratio, HER2 ISH signals, HER2 H-score, plasma HER2 (ERBB2) amplification status, HER2 adjusted plasma copy number, and HER2 extracellular domain correlate with antitumor activity (indicated by objective response rate, progression-free survival, and overall survival) of T-DXd. Baseline circulating tumor DNA (ctDNA) analysis suggests antitumor activity of T-DXd in patients who had baseline activating RAS, PIK3CA, or HER2 mutations detected in ctDNA.

Date: 2024
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DOI: 10.1038/s41467-024-53223-3

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