Imaging study highlighted at ASCO reveals many women may receive wrong HER2 therapy

Solna, June 1, 2015. – Affibody AB today announced the presentation of a clinical study at American Society of Clinical Oncology (ASCO).

In breast cancer patients, knowledge of the HER2 (human epidermal growth factor receptor type 2) status is crucial to predict whether an individual will respond to HER2-targeted therapy. Such therapy, e.g. Genentech’s Herceptin^® (trastuzumab) has greatly benefitted breast cancer patients over the last decade and is regarded as the beginning of a new era of personalized medicine. However, an important study presented at ASCO in Chicago today with a new non-invasive imaging agent, shows that there are often unexpected changes in HER2 status from the primary tumor during metastatic disease, which may lead to women receiving the wrong therapy.

In the study, sixteen women with known metastatic breast cancer and on-going treatment were included and underwent PET/CT to identify viable metastases. Twelve had HER2-positive primary tumors and four were included as HER2-negative controls. The PET imaging agent ABY-025 is based on an Affibody^® molecule that binds strongly to HER2.The rapid clearance of ABY-025 from blood and normal organs allowed HER2 assessment within 2-4 hours. The ABY-025 assessment prompted the treating physician to modify treatment in several patients.

“We believe this study has major implications for women undergoing HER2-targeted therapy since it clearly shows that their HER2 status in the metastasis can change or be heterogenous, and thus necessitate a change in treatment,” says David Bejker, CEO of Affibody. “We now hope that imaging using this new agent will become routine for metastatic breast cancer patients.”