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Authors
Badve, Sunil S. https://orcid.org/0000-0001-8861-9980
Shiller, Michelle https://orcid.org/0009-0006-8526-6327
Yang, Wentao
Bridge, Helen https://orcid.org/0000-0001-5499-2496
Brown, Adam https://orcid.org/0000-0002-9122-4960
Luo, Linlin https://orcid.org/0000-0002-7527-5303
Michelini, Flavia https://orcid.org/0000-0002-3727-4887
Raiber-Moreau, Eun-Ang https://orcid.org/0000-0003-2102-6931
Rüschoff, Josef
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Funding
Funding for this research was provided by:
AstraZeneca
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Article History
Received: 17 November 2025
Revised: 15 December 2025
Accepted: 31 December 2025
First Online: 11 February 2026
Declarations
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: This study used tumor sample images from Part 1 of the DESTINY-PanTumor02 study. DESTINY-PanTumor02 Part 1 was conducted in accordance with the Declaration of Helsinki, Good Clinical Practice guidelines defined by the International Conference on Harmonisation, and local regulations on the conduct of clinical research; all patients provided written informed consent.
: Sunil S. Badve has received grants from the National Cancer Institute and from Eli Lilly to his institution and personal fees from Agilent, AstraZeneca, BMS, and Daiichi Sankyo. Michelle Shiller is an employee of PathGroup Genomic and Molecular Pathology Services; has received speaker fees from Amgen, AstraZeneca, Bayer, BMS, Merck, Takeda, and GSK; and serves on the advisory boards for AbbVie, Amgen, AstraZeneca, Merck, and Pfizer. Wentao Yang declares no relevant financial or non-financial interests to disclose. Helen Bridge is a former employee of AstraZeneca and holds stocks/shares in AstraZeneca. Adam Brown is an employee of Daiichi Sankyo and holds stocks/shares in Daiichi Sankyo. Linlin Luo is an employee of AstraZeneca and holds stocks/shares in AstraZeneca. Flavia Michelini is an employee of AstraZeneca. Eun-Ang Raiber-Moreau is an employee of AstraZeneca and holds stocks/shares in AstraZeneca. Josef Rüschoff has received honoraria as an invited speaker and for participation in advisory boards of Astellas, AstraZeneca, BMS, Daiichi Sankyo, GSK, MSD/Merck, and Sanofi.
: These data were previously presented at ESMO 2024, September 13–17, 2024, Barcelona, Spain, by Dr Wentao Yang.
: For simplicity, Roche HER2 4B5 Assay is a general descriptor to represent the PATHWAY/VENTANA HER2 (4B5) assays that are marketed globally through various product names, each with specialized indications per regional approvals. “Roche HER2 4B5 Assay” is not a marketed device, but a descriptor to represent several marketed devices: The PATHWAY® anti-HER-2/neu (4B5) rabbit monoclonal primary antibody is available in the USA and in some regions; VENTANA anti-HER2/neu (4B5) rabbit monoclonal primary antibody is available in some regions per in vitro diagnostics medical directive (RD); VENTANA HER2 (4B5) rabbit monoclonal primary antibody RxDx is available for regions following in vitro diagnostics regulation (IVDR) conformity assessment. Additionally, the VENTANA HER2/neu (4B5) IUO assay is an investigational use device with the same formulation as the PATHWAY/VENTANA marketed devices and therefore may also be referred to by the general descriptor: Roche HER2 (4B5) Assay. For indications available according to the region, please refer to the most updated product labeling available per region.
