Neutralizing antibodies (NAbs) to trastuzumab are a subset of anti-drug antibodies (ADAs) that directly impair the drug’s pharmacological activity by preventing its binding to the HER2 receptor. Trastuzumab, a monoclonal antibody targeting HER2-positive tumors, can elicit an immune response in some patients, resulting in the formation of these neutralizing antibodies. NAbs interfere with trastuzumab’s mechanism of action, which involves blocking HER2-mediated intracellular signaling pathways and inducing antibody-dependent cell-mediated cytotoxicity (ADCC). As a result, the therapeutic efficacy of trastuzumab may be diminished or lost.
In clinical and research settings, the detection and monitoring of neutralizing antibodies to trastuzumab are essential for understanding treatment failure, patient resistance, and immunogenicity. NAbs can be assessed through ligand-binding immunoassays such as the SHIKARI® T-CAP NAb assay, which identifies interference in drug-receptor binding. These assays are particularly important in long-term treatments, where continued exposure increases the risk of ADA formation, and in patients showing unexpected disease progression or reduced drug response.
Therapeutic drug monitoring (TDM) that includes NAb evaluation supports personalized treatment strategies by enabling clinicians to distinguish between pharmacokinetic issues and immunogenic responses. Incorporating NAb monitoring into clinical protocols helps optimize dosage regimens, avoid adverse immune events, and improve compliance in nonresponsive patients. In research, these assays are vital for evaluating biosimilar equivalence, immune safety profiling, and understanding resistance mechanisms in HER2-targeted therapies.
This product is manufactured in Turkey by Matriks Biotek.