泽尼达妥单抗的适应症

Zenidatuzumab is a bispecific antibody drug targeting HER2-positive biliary tract cancer, providing a new targeted treatment option for patients who have previously received treatment. The drug blocks the HER2 signaling pathway through a unique mechanism of action and simultaneously activates the immune system to attack tumor cells. This article will introduce in detail the indications, efficacy and mechanism of action of zenidatuzumab, as well as important information such as contraindications for use.

Indications of Zenidatuzumab

Zenidatuzumab has clear therapeutic indications and is mainly targeted at patients with specific types of biliary tract cancer.

HER2-positive biliary tract cancer

Zenidatuzumab is suitable for the treatment of adult patients with unresectable or metastatic HER2-high expression (IHC3+) biliary tract cancer that has progressed after previously receiving gemcitabine-containing chemotherapy. It is the first bispecific antibody therapy in the world approved for such indications.

Patient Selection Criteria

Before use, the HER2-positive status (IHC3+) needs to be confirmed by an FDA-approved testing method. It is only applicable to unresectable or metastatic cases, and the patient must have a history of previous systemic chemotherapy treatment.

Zenidatuzumab provides precise targeted treatment options for patients with specific types of biliary tract cancer, filling the treatment gap in this field.

The efficacy and role of zenidatuzumab

Zenidatuzumab exerts anti-tumor effects through multiple mechanisms, showing unique therapeutic advantages.

Double signal blocking

The drug can simultaneously bind to two non-overlapping epitopes (ECD2 and ECD4) of the HER2 protein to form dual signal blocking, more effectively inhibiting the growth and proliferation of tumor cells.

Immune system activation

Zenidatuzumab can activate complement-dependent cytotoxicity (CDC), antibody-dependent cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP), mobilizing the immune system to jointly attack tumor cells.

Clinical efficacy performance

In clinical trials, zenidatuzumab showed the effect of prolonging progression-free survival, providing new treatment hope for patients with advanced biliary tract cancer.

Zenidatuzumab’s multiple mechanisms of action make it an important breakthrough in the treatment of HER2-positive biliary tract cancer.

Contraindications of zenidatuzumab

There are clear contraindications and usage restrictions for the use of zenidatuzumab.

Contraindicated during pregnancy

The drug has embryo-fetal toxicity and may cause abnormal fetal development or even death. It is absolutely contraindicated for pregnant women, and women of childbearing age need to take strict contraceptive measures.

Severe heart disease

Patients with baseline left ventricular ejection fraction (LVEF) lower than 50% need to carefully assess the risk. If there is a significant decline in cardiac function during treatment, the drug must be discontinued immediately.

Restrictions for special groups

The safety and effectiveness in pediatric patients have not been established, and lactating women need to suspend breastfeeding. Data on use in patients with hepatic and renal impairment are limited and require individualized evaluation.

Patients should understand the contraindications of zenidatumab, and clinical use must strictly follow relevant regulations.