In this article
- FDA Approves Zolbetuximab-clzb with Chemotherapy for Gastric or Gastroesophageal Junction Adenocarcinoma
- SPOTLIGHT and GLOW Trials – Efficacy and Safety of Zolbetuximab-clzb in Gastric and GEJ Adenocarcinoma
- Recommended Dosage of Zolbetuximab-clzb for Gastric and GEJ Adenocarcinoma
- How CancerFax Helps
On October 18, 2024, the Food and Drug Administration sanctioned zolbetuximab-clzb (Vyloy, Astellas Pharma US, Inc.), a claudin 18.2 (CLDN18.2)-targeted cytolytic antibody, in conjunction with fluoropyrimidine- and platinum-based chemotherapy, for the initial treatment of adults with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma exhibiting CLDN18.2 positivity, as verified by an FDA-approved assay.
Today, the FDA authorized the VENTANA CLDN18 (43-14A) RxDx Assay (Ventana Medical Systems, Inc./Roche Diagnostics) as a companion diagnostic tool to identify patients with gastric or gastroesophageal junction adenocarcinoma who may qualify for therapy with zolbetuximab.
The efficacy was assessed in the SPOTLIGHT (NCT03504397) and GLOW (NCT03653507) trials. Both trials were randomized (1:1), double-blind, and multicenter, enrolling patients with CLDN18.2 positive advanced unresectable or metastatic HER2-negative stomach or gastroesophageal junction cancer. The primary effectiveness endpoint in both studies was progression-free survival (PFS), evaluated according to RECIST v1.1 by an independent review committee. Overall survival (OS) constituted an additional efficacy outcome metric.
In the SPOTLIGHT trial, 565 patients were randomized to receive either zolbetuximab-clzb in conjunction with mFOLFOX6 chemotherapy or a placebo alongside mFOLFOX6 chemotherapy. The median progression-free survival (PFS) was 10.6 months (95% CI: 8.9, 12.5) in the zolbetuximab-clzb/chemotherapy group and 8.7 months (95% CI: 8.2, 10.3) in the placebo/chemotherapy group (hazard ratio [HR] 0.751 [95% CI: 0.598, 0.942]; 1-sided p-value=0.0066). The median overall survival (OS) was 18.2 months (95% CI: 16.4, 22.9) and 15.5 months (95% CI: 13.5, 16.5), respectively, with a hazard ratio (HR) of 0.750 (95% CI: 0.601, 0.936) and a one-sided p-value of 0.0053.
In GLOW, 507 patients were randomized to receive either zolbetuximab-clzb in conjunction with CAPOX chemotherapy or a placebo alongside CAPOX chemotherapy. The median progression-free survival (PFS) was 8.2 months (95% CI: 7.5, 8.8) in the zolbetuximab-clzb/chemotherapy group and 6.8 months (95% CI: 6.1, 8.1) in the placebo/chemotherapy group (hazard ratio [HR] 0.687 [95% CI: 0.544, 0.866]; 1-sided p-value=0.0007). The median overall survival (OS) was 14.4 months (95% CI: 12.3, 16.5) and 12.2 months (95% CI: 10.3, 13.7), respectively (HR 0.771 [95% CI: 0.615, 0.965]; 1-sided p-value=0.0118).
The predominant severe adverse effects in SPOTLIGHT (≥2%) included vomiting, nausea, neutropenia, febrile neutropenia, diarrhea, intestinal obstruction, pyrexia, pneumonia, respiratory failure, pulmonary embolism, diminished appetite, and sepsis. The predominant severe side events in GLOW (≥2%) included vomiting, nausea, reduced appetite, diminished platelet count, upper gastrointestinal bleeding, diarrhea, pneumonia, pulmonary embolism, and fever.
The advised dosage of zolbetuximab-clzb in conjunction with fluoropyrimidine- and platinum-based chemotherapy is:
Initial dose: 800 mg/m² intravenously.
Subsequent doses: 600 mg/m² intravenously every 3 weeks, or 400 mg/m² intravenously every 2 weeks.
How CancerFax Helps
CancerFax is a specialist cancer access and patient-navigation platform. We help patients and families understand their options, organise medical records, coordinate hospital communication, and support cross-border treatment planning where appropriate.
We help collect and organise reports, scans, pathology, biomarker results, and treatment history for structured case review.
We communicate with hospitals or trial teams to assess whether a case may be suitable for further screening.
We support appointment coordination, document submission, translation, and direct communication with international departments.
For international patients, we help with practical coordination — travel planning, hospital admission guidance, and local support.
If this option is not suitable, we help explore other relevant treatments, clinical trials, or advanced care pathways.
From inquiry through to follow-up, our coordinators provide a single point of contact for the family.
CancerFax does not guarantee treatment access, eligibility, or clinical outcome. Our role is to help patients access accurate information, structured review, and appropriate specialist pathways.
About Sai Sree
✓ Reviewed for medical accuracy by the CancerFax review panel.
Medical Disclaimer
This article is for educational purposes only and should not replace medical advice, diagnosis, or treatment from a qualified oncology specialist. Every patient's case is different. Treatment decisions should always be made after a review of complete medical records by the treating medical team.
Treatment availability, eligibility, timelines, and access can change. Any clinical trial participation depends on detailed review and approval by the trial hospital or investigator.