Analysis of the real therapeutic effect of Datopotamab

Datopotomab (Datopotamab) is a new type of drug for cancer treatment, which is an antibody drug conjugate (ADC). This drug has been approved by the FDA for the treatment of patients with unresectable or metastatic breast cancer, specifically those who are hormone receptor-positive and human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC1+, or IHC2+/ISH-). These patients have previously received treatments based on endocrine therapy and chemotherapy and still face incurable disease progression. As a new type of antibody-drug conjugate, the efficacy of dabrotuzumab has been initially verified in clinical studies and has provided significant therapeutic effects for some patients.

The mechanism of action of dedabrotuzumab is based on antibody-drug conjugate technology, which couples an anti-HER2 antibody with a potent cytotoxic drug (deruxtecan) through a chemical linker. When the drug enters the cancer cell, the antibody part first binds and recognizes the HER2 antigen on the surface of the cancer cell, and then enters the cell through endocytosis. After the drug enters the cells, cytotoxins are released, inhibiting the proliferation of cancer cells and causing cell apoptosis. This precise mechanism of action allows dedabrotomab to effectively target HER2-negative cancer cells while reducing damage to normal cells, thereby improving efficacy and reducing side effects.

Clinical studies of dabrotuzumab have shown that the drug can significantly improve the effectiveness of treatment in patients with breast cancer. Patients treated with dabrotumumab showed significant improvements in tumor control rate, progression-free survival (PFS) and overall survival (OS), according to results from a pivotal clinical trial. Especially for breast cancer patients who are resistant to traditional treatments, such as endocrine therapy and chemotherapy, dabrotuzumab offers a new treatment option.

In patients with non-small cell lung cancer (NSCLC), dabrotuzumab also shows good therapeutic effects. In June 2025, the FDA approved the expanded indications of dabrotuzumab to include the treatment of adult patients with locally advanced or metastatic EGFR-mutant non-small cell lung cancer (NSCLC). These patients had previously received epidermal growth factor receptor (EGFR)-guided therapy and platinum-based chemotherapy. The approval of the expanded indication brings new treatment hope to NSCLC patients, especially those who have poor response to traditional treatment options.

Reference materials:https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2950227c-6230-4ca4-a135-46e44d9424a0