Vyloy (zolbetuximab) is a groundbreaking cancer treatment specifically designed for gastric cancer and gastroesophageal junction cancer (GEJ). It targets the Claudin 18.2 protein on cancer cells, effectively killing them and slowing tumor growth. This innovative treatment has been shown to increase progression-free survival (PFS) and overall survival (OS) rates among patients.
FDA Approval and Clinical Trials
The FDA granted approval for Vyloy on October 18, 2024, following promising results from the GLOW (NCT03653507) and SPOTLIGHT (NCT03504397) clinical trials. In the SPOTLIGHT trial, patients treated with Vyloy combined with chemotherapy experienced a median PFS of 10.6 months, compared to 8.7 months for those receiving a placebo with chemotherapy. The median overall survival was 18.2 months for the Vyloy group versus 15.5 months for the placebo group.
How Vyloy Works
Vyloy operates as a Claudin 18.2-directed cytolytic antibody, binding to the CLDN18.2 protein on tumor cells. It then induces antibody-dependent cellular cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC), mechanisms that contribute to the destruction of cancer cells and the slowing of tumor growth.
Side Effects
Common side effects include nausea, vomiting, fatigue, fever, decreased appetite, diarrhea, peripheral sensory neuropathy, stomach pain, constipation, decreased weight, and hypersensitivity reactions. Serious side effects may involve severe allergic reactions and severe nausea and vomiting, necessitating immediate medical attention.
Administration and Dosage
Vyloy is administered via intravenous (IV) infusion, typically every 2 or 3 weeks, in combination with fluoropyrimidine- and platinum-containing chemotherapy. The initial dose is 800 mg/m2, followed by 600 mg/m2 every 3 weeks or 400 mg/m2 every 2 weeks.
Precautions
Patients should inform their healthcare provider about any nausea or vomiting and discuss pregnancy, breastfeeding, and potential drug interactions before starting treatment with Vyloy.
Storage
Vyloy vials should be stored refrigerated at 2°C to 8°C (36°F to 46°F) and not frozen. Reconstituted vials can be kept at room temperature for up to 5 hours, while diluted infusions should be used within 6 hours at room temperature or 16 hours if refrigerated.
Vyloy represents a significant advancement in the treatment of CLDN18.2 positive, HER2-negative, metastatic or unresectable gastric and GEJ cancers, offering new hope to patients facing these challenging conditions.
