Dato-DXd is currently in 12 clinical trials, assessing the safety and efficacy in different tumour types. Credit: CHRISTOPH BURGSTEDT/SCIENCE PHOTO LIBRARY via Getty Images.

Daiichi Sankyo and AstraZeneca have reported positive interim data for datapotamab deruxtecan (Dato-DXd) to treat inoperable or metastatic hormone receptor (HR) positive, HER2 negative breast cancer, previously treated with endocrine-based therapy and systemic therapy.  

The companies presented data from the TROPION-Breast01 (NCT05104866) trial in a Presidential Symposium at the European Society for Medical Oncology (ESMO) 2023 Congress in Madrid on 23 October.

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Dato-DXd reduced the risk of disease progression or death by 37% compared to chemotherapy, but the results did not reach statistical significance at the time of cut-off.  

The global, randomised, multicentre, open-label Phase III trial assessed the safety and efficacy of Dato-DXd, a specifically engineered TROP2-directed DXd antibody-drug conjugate (ADC). The dual primary endpoints are progression-free survival (PFS) as assessed by the blinded independent central review (BICR) and overall survival (OS). The study enrolled more than 700 patients globally.  

AstraZeneca oncology R&D executive vice-president Susan Galbraith said: “With these TROPION-Breast01 results, datopotamab deruxtecan has the potential to meaningfully improve treatment expectations for patients with HR-positive, HER2-low or negative metastatic breast cancer.

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“We look forward to continuing discussions with regulatory authorities with the goal of bringing this TROP2-directed antibody-drug conjugate to eligible patients as soon as possible.” 

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Dato-DXd is currently in twelve clinical trials as part of the TROPION development programme, evaluating the drug across multiple tumours, including non-small cell lung cancer (NSCLC), triple-negative breast cancer (TNBC), and hormone receptor-positive, HER2-low or negative breast cancer. 

Positive data from the TROPION-Lung01 was reported in July for Dato-DXd to treat NSCLC, which showed a statistically significant improvement in PFS compared to the standard treatment, docetaxel.  

According to GlobalData, Dato-DXd’s sales forecast is estimated to exceed $2.5bn by 2029. GlobalData predicts that AstraZeneca/Daiichi Sankyo’s datopotamab deruxtecan will lead the market. GlobalData is the parent company of Clinical Trials Arena.