Company: AZN
Filing Date: 2025-09-29
Form Type: 6-K
Source: 0001654954-25-011177
Chunk: 2

Company: ASTRAZENECA PLC
Filing Date: 2025-09-29
Form: 6-K
Chunk 2
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 profile of Enhertu observed in DESTINY-Breast05 was consistent with its known profile with no new safety concerns identified.

Enhertu is a specifically engineered HER2-directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed and commercialised by AstraZeneca and Daiichi Sankyo.

Data from DESTINY-Breast05 (Abstract #LBA1) and DESTINY-Breast11 (Abstract #291O) will be presented during Presidential Symposium 1 on 18 October at the upcoming European Society for Medical Oncology (ESMO) Congress 2025. The DESTINY-Breast05 data will also be shared with global regulatory authorities.

DESTINY-Breast05 was conducted in collaboration with the National Surgical Adjuvant Breast and Bowel Project Foundation (NSABP), the German Breast Group (GBG), Arbeitsgemeinschaft Gynäkologische Onkologie (AGO-B) and SOLTI Breast Cancer Research Group.

#### Notes

#### HER2-positive early breast cancer
Breast cancer is the second most common cancer and one of the leading causes of cancer-related deaths worldwide. 12 More than two million breast cancer cases were diagnosed in 2022, with more than 665,000 deaths globally. 12

HER2 is a tyrosine kinase receptor growth- promoting protein expressed on the surface of many types of tumours including breast cancer. 13 HER2 protein overexpression may occur as a result of HER2 gene amplification and is often associated with aggressive disease and poor prognosis in breast cancer. 14 Approximately one in five cases of breast cancer are considered HER2-positive. 15

Currently, 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, some patients still ultimately experience tumour progression to metastatic disease. 8-10 Once patients are diagnosed with metastatic disease, the five-year survival rate drops from nearly 90 percent to approximately 30 percent. 16 New treatment options are needed in the early breast cancer setting to help reduce the likelihood of disease progression in order to improve long-term outcomes for more patients. 10-11

#### DESTINY-Breast05
DESTINY-Breast05 is a global, multicentre, randomised, open-label, Phase III trial evaluating the efficacy and safety of