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Zolbetuximab-clzb

(Vyloy®)

Vyloy®

Drug updated on 12/11/2024

Dosage FormInjection (intravenous; 100 mg lyophilized powder in a single-dose vial)
Drug Classclaudin 18.2-directed cytolytic antibodies
Ongoing and
Completed Studies		ClinicalTrials.gov

Indication

  • Indicated in combination with fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adults with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction adenocarcinoma whose tumors are claudin (CLDN) 18.2 positive as determined by an FDA-approved test.

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Summary
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  • This summary is based on the review of three systematic review(s)/meta-analysis(es). [1-3]
  • Progression-Free Survival (PFS): Zolbetuximab plus chemotherapy significantly improved PFS compared to chemotherapy alone across studies (hazard ratio (HR) 0.64; 95% confidence interval (CI) 0.49–0.84, p<0.01; HR 0.64; 95% CI 0.50–0.82). In the "specific positivity" group, the benefit was more pronounced (HR 0.45; 95% CI 0.25–0.81).
  • Overall Survival (OS): Zolbetuximab plus chemotherapy consistently improved OS (HR 0.72; 95% CI 0.62–0.83, p<0.01; HR 0.73; 95% CI 0.68–0.84). Patients with high claudin (CLDN) 18.2 expression showed greater benefit (HR 0.69; 95% CI 0.55–0.87, p=0.002), and in the "specific positivity" group, OS was significantly extended (HR 0.53; 95% CI 0.36–0.79).
  • Objective Response Rate (ORR): No significant improvement in ORR was observed with Zolbetuximab plus chemotherapy (OR 1.15; 95% CI 0.87–1.53, p=0.34; RR 0.92; 95% CI 0.82–1.03).
  • Zolbetuximab plus chemotherapy was associated with a higher risk of grade 3 or higher adverse events, particularly nausea and vomiting, in the general population.
  • No significant safety risks were reported for Zolbetuximab-chemotherapy, trastuzumab plus pertuzumab-chemotherapy, and nivolumab-chemotherapy in the "specific positivity" group.
  • The reviewed evidence focuses on patients with advanced CLDN18.2-positive gastric or gastroesophageal junction adenocarcinoma, with findings indicating more significant benefits in OS and PFS for those with high CLDN 18.2 expression when treated with Zolbetuximab plus chemotherapy.