What does the detailed instructions for Zotuximab/Veloximab contain?

Zolbetuximab (zolbetuximab)-VYLOY is an innovative targeted anti-cancer drug. Its scientific name is zolbetuximab-clzb, which belongs to the monoclonal antibody class. As one of the few therapeutic options targeting CLDN18.2 protein in the world, it has important clinical significance in the treatment of gastric cancer and gastroesophageal junction adenocarcinoma (GEJ adenocarcinoma).

1. In terms of indications

Vyloy is currently mainly approved for adult patients with HER2-negative, CLDN18.2-positive gastric adenocarcinoma and GEJ adenocarcinoma. Especially those patients with locally advanced unresectable or metastatic disease can be treated with standard chemotherapy regimens containing fluoropyrimidine and platinum. The FDA's approval is based on data from multiple international clinical trials, which proves its advantages in extending survival and improving tumor control rates. It is worth noting that CLDN18.2, as a tight junction protein, has limited expression in normal gastric mucosa, but is expressed at high levels in some gastric cancer tissues, which also provides a solid biological basis for it to become a new target.

2. Medication Management

Before treatment, patients need to undergo immunohistochemistry testing to confirm whether there are ≥75% of cells showing moderate to strong positive expression in tumor cells. If the test results meet the conditions, the patient will have the opportunity to benefit from Vyloy treatment. In addition, if the patient has obvious nausea, vomiting and other symptoms before use, these discomforts need to be controlled to a mild range first. Doctors usually combine antiemetics before infusion to reduce the risk. The recommended dosage of Vyloy is an initial intravenous infusion dose of 800 mg/m², followed by 600 mg/m² every three weeks or 400 mg/m² every two weeks until disease progression or intolerable adverse reactions occur. When combined with chemotherapy, it is often recommended to infuse Vyloy first to ensure that the efficacy of the drug is not affected.

3. Side effects

During clinical application, the most common adverse reactions include nausea, vomiting, loss of appetite, fatigue, diarrhea, weight loss, and peripheral neuropathy etc. The incidence of these side effects exceeds 15% in multiple studies, so doctors need to closely monitor and treat symptoms during treatment. In addition, laboratory tests also show that some patients will experience abnormal indicators such as decreased neutrophil count and albumin level, so regular hematology examinations are essential. Despite this, clinical data still show that its overall safety is within a controllable range, and most side effects can be alleviated with supportive care.

4. Drug Storage

The pharmaceutical form of Vyloy is a sterile injection, each bottle contains 100 mg of the active ingredient zolbetuximab-clzb. During storage, it must be kept under refrigerated conditions of 2°C to 8°C, and avoid light and shaking, so as to maintain the stability and activity of the drug.

5. Mechanism of action

Vyloy's mechanism of action is to trigger antibody-dependent cellular cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC). Simply put, when the drug binds to CLDN18.2-positive tumor cells, it will act like a "marking signal" to guide the immune system's natural killer cells and complement system to attack the target, thereby achieving precise killing. This mechanism also enables Vyloy to produce a synergistic effect when combined with chemotherapy, significantly improving treatment efficiency. Animal experiments and early clinical data show that it can enhance the overall anti-tumor ability of chemotherapy drugs and bring longer disease control time to patients.

Reference materials:https://www.astellas.com/en/news/29401