ESMO23: AstraZeneca, Daiichi’s dato-DXd slashes risk of disease progression, death by 37% in breast cancer study

23 Oct 2023
firstwordpharma.com
Clinical ResultPhase 3ADCASCO
Results from the Phase III TROPION-Breast01 trial showed that AstraZeneca and Daiichi Sankyo’s datopotamab deruxtecan (dato-DXd) reduced the risk of disease progression or death by 37% compared to chemotherapy in certain patients with breast cancer. The data – top-lined last month – were presented Monday at the European Society of Medical Oncology (ESMO) congress.
The trial is evaluating the TROP2-directed antibody-drug conjugate (ADC) dato-DXd versus investigator's choice of single-agent chemotherapy in over 700 patients with inoperable or metastatic HR+/HER2-low or negative breast cancer who have previously progressed on or are not suitable for endocrine therapy per investigator assessment.
Results detailed at ESMO showed that median progression-free survival (PFS) was 6.9 months in patients treated with dato-DXd – with a consistent benefit across subgroups - versus 4.9 months for chemotherapy. Further data showed that the confirmed objective response rate (ORR) was 36.4% in patients treated with dato-DXd compared to 22.9% with chemotherapy.
AstraZeneca and Daiichi Sankyo added that for the study’s dual primary endpoint of overall survival (OS), interim results numerically favoured dato-DXd over chemotherapy with a hazard ratio of 0.84. However, the companies noted that the results did not reach statistical significance at the time of this data cut-off.
Study investigator Aditya Bardia remarked “in the TROPION-Breast01 trial, [dato-DXd] reduced patients’ risk of disease progression or death by more than a third and overall had fewer treatment-related serious adverse events than standard chemotherapy, illustrating its potential to become a new standard of care.”
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