The drug ifinatamab-deruxtecan as a new treatment option for various advanced/metastatic cancers, including HER2-negative/low-detectable breast cancer

Solid tumors are growths of tissue that can develop in various organs or tissues of the body. They can be benign or malignant. Breast cancer is one example of a malignant solid tumor. In the locally advanced stage or when metastases have already been detected (Stage 4), a cure is generally no longer possible. In these cases, the goal of treatment is to control the disease for as long as possible.

While traditional chemotherapy drugs attack both cancerous and healthy cells indiscriminately and can therefore cause significant side effects, modern therapies are increasingly relying on targeted mechanisms to combat tumors. In many cases, these strategies have led to improved efficacy and better tolerability, although individual responses to treatment may vary. A novel therapeutic approach combines immunotherapy (antibodies) with a chemotherapy drug. The antibody delivers the chemotherapy specifically to the tumor cells, thereby enhancing its effect while sparing healthy tissue. Ifinatamab-deruxtecan (I-DXd) belongs to this class of drugs. There are already approved drugs based on a similar mechanism of action.

The goal of the IDeate-PanTumor02 study is to test ifinatamab deruxtecan (I-DXd) in patients with various types of cancer when the disease is advanced or metastatic and has not responded adequately to previous treatments. This includes breast cancer that is metastatic or no longer operable. A prerequisite is that the breast cancer cells have no detectable HER2 receptor on their surface, or only a low level of it. All patients will receive the experimental therapy with ifinatamab deruxtecan. In the first phase of the study, tolerability and safety will be assessed; treatment will then continue over a longer period. The medication is administered as an intravenous infusion. The duration of treatment depends on the response to therapy as well as individual tolerability. Follow-up of study participants extends over a period of approximately 57 months.

Women and men aged 18 and older with certain solid tumors are eligible to participate in the IDeate-PanTumor02 study if the disease is at a locally advanced or metastatic stage, can no longer be surgically removed, and at least one prior systemic therapy has already been administered without success. The exact inclusion and exclusion criteria vary depending on the type of tumor. In the case of breast cancer, the HER2 receptor must be either undetectable or present only in small amounts. In addition, prior treatment with trastuzumab deruxtecan is required, and patients must have received at least two but no more than three prior systemic therapies.