New Approval for the Treatment of Hormone Receptor-Positive, HER2-Negative Breast Cancer
Currently, the treatment of metastatic breast cancer that is hormone receptor-positive (HR+) and does not express human epidermal growth factor receptor-2 (HER2-) involves endocrine therapy (anti-hormone therapy) in combination with targeted agents, followed by mono-chemotherapy (with one agent). This treatment approach does not always provide optimal results and is often associated with a reduced quality of life. In the Phase III study “TROPiCS-02”, the antibody-drug conjugate sacituzumab govitecan was evaluated, and its efficacy and safety were compared with treatment of physician’s choice in patients with HR+ and HER2- metastatic breast cancer.
The active substance sacituzumab govitecan consists of an antibody (sacituzumab) to which a cytostatic (cell division inhibiting) substance is bound. After administration, the antibody specifically binds to a certain protein on the surface of the cancer cells. This binding ensures that the cytostatic agent detaches and is thereby activated. The thus released cytostatic then causes damage to the genetic material, leading to the death of the cancer cell.
Sacituzumab Govitecan is already approved in several countries for patients with metastatic triple-negative breast cancer who have received more than one prior systemic therapy, and in the USA for patients with pre-treated HR+/HER2- metastatic breast cancer. In the TROPiCS-02 study, patients who had been previously treated and whose metastatic breast cancer was resistant to endocrine therapy showed a clinically significant survival benefit when treated with sacituzumab govitecan, compared to the patient group receiving treatment of physician’s choice.
Based on these study results, the US Food and Drug Administration (FDA) has now also approved the antibody-drug conjugate sacituzumab govitecan (Trodelvy®) for the treatment of adult patients suffering from inoperable, locally advanced or metastatic HR+/HER2- breast cancer who have previously received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting.[/vc_column_text][/vc_column][/vc_row]
