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Enhertu improved IDFS in early BC in DB-05
AstraZeneca PLC announced positive results from a planned interim analysis of the DESTINY-Breast05 Phase III trial. Enhertu demonstrated a highly statistically significant and clinically meaningful improvement in invasive disease-free survival (IDFS) versus trastuzumab emtansine (T-DM1) in patients with HER2-positive early breast cancer with residual invasive disease after neoadjuvant treatment. The trial enrolled 1,635 patients globally. Overall survival (OS) data was not mature at the time of this analysis and will be assessed later. The DESTINY-Breast05 data will be shared with global regulatory authorities and presented at ESMO 2025. This is the second positive Phase III trial of Enhertu in the HER2-positive early breast cancer setting. Disclaimer*
About this update from Astrazeneca Plc
[{"type":"text","content":"\n\n \n29 September 2025\n \nEnhertu demonstrated highly statistically significant and clinically meaningful improvement in invasive disease-free survival vs. T-DM1 in DESTINY-Breast05 Phase III trial in patients with high-risk early breast cancer following neoadjuvant therapy\n \nSecond positive Phase III trial of AstraZeneca and Daiichi Sankyo's Enhertu in HER2-positive early breast cancer reinforces its potential to become a foundational treatment option in curative-intent setting\n \nResults from the DESTINY-Breast05 and DESTINY-Breast11 trials\nwill be presented at ESMO 2025 in a Presidential Symposium\n \nPositive high-level results from a planned interim analysis of the DESTINY-Breast05 Phase III trial showed Enhertu (trastuzumab deruxtecan) demonstrated a highly statistically significant and clinically meaningful improvement in invasive disease-free survival (IDFS) versus trastuzumab emtansine (T-DM1) in patients with HER2-positive early breast cancer with residual invasive disease in the breast or axillary lymph nodes after neoadjuvant treatment and a high risk of disease recurrence. This is the second positive Phase III trial of Enhertu in the HER2-positive early breast cancer setting following positive results from the DESTINY-Breast11 Phase III neoadjuvant trial earlier this year.\n \nOverall survival (OS) was not mature at the time of this planned interim analysis and will be assessed at a subsequent analysis.\n \nCurrently, approximately half of patients with HER2-positive early breast cancer have residual disease following neoadjuvant treatment, putting them at an increased risk of disease recurrence.1-7 Despite receiving additional treatment in the post-neoadjuvant setting with current standards of care, some patients still ultimately experience tumour progression to metastatic disease.8-10 New treatment options are needed in the early breast cancer setting to help reduce the likelihood of disease progression and improve long-term outcomes for more patients.10-11\n \nSusan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, said: \"This landmark trial is the first to directly compare Enhertu and T-DM1 in early breast cancer, and the results clearly show that Enhertu delivers superior outcomes, indicating that it may be a better option for patient...