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Phase II TUXEDO-1 trial of Enhertu in breast cancer with brain metastases published in Nature Medicine

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Published:11th Aug 2022

Nature Medicine has published results from a prospective, open-label, single-arm, phase II TUXEDO-1 trial of Enhertu (trastuzumab deruxtecan), from Daiichi Sankyo + AstraZeneca, which enrolled patients aged at least 18 years with HER2-positive breast cancer and newly diagnosed untreated brain metastases or brain metastases progressing after previous local therapy, previous exposure to trastuzumab and pertuzumab and no indication for immediate local therapy

Patients received trastuzumab deruxtecan intravenously at the standard dose of 5.4 mg per kg bodyweight once every 3 weeks. The primary endpoint was intracranial response rate measured according to the response assessment in neuro-oncology brain metastases criteria.

Two patients (13.3%) had a complete intracranial response, nine (60%) had a partial intracranial response and three (20%) had stable disease as the best intracranial response, with a best overall intracranial response rate of 73.3% (95% confidential interval 48.1–89.1%), thus meeting the predefined primary outcome. No new safety signals were observed and global quality-of-life and cognitive functioning were maintained over the treatment duration. The TUXEDO-1 trial (NCT04752059, EudraCT 2020-000981-41) shows trastuzumab deruxtecan led to a high intracranial response rate in patients with active brain metastases from HER2-positive breast cancer and data suggests that Enhertu should be considered as a treatment option in this setting.

See: "Trastuzumab deruxtecan in HER2-positive breast cancer with brain metastases: a single-arm, phase 2 trial" Rupert Bartsch et al. Nature Medicine (2022) Published: 08 August 2022

Condition: Breast Cancer/HER 2 low
Type: drug

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