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Zolbetuximab plus CAPOX or mFOLFOX6
Source: Gastric Cancer Treatment (PDQ®)–Health Professional Version, National Cancer Institute.
Source updated: February 21, 2025 · Captured 2026-09-09.
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Two randomized trials tested the addition of zolbetuximab to either CAPOX or mFOLFOX6 in patients with CLDN18.2-positive, HER2-negative metastatic gastroesophageal or gastric adenocarcinoma.[1,2]
Evidence (zolbetuximab with chemotherapy):
In the phase III GLOW trial (NCT03653507), 507 patients were randomly assigned to receive CAPOX and either zolbetuximab or placebo.[1]
In the phase III GLOW trial (NCT03653507), 507 patients were randomly assigned to receive CAPOX and either zolbetuximab or placebo.[1]
The median PFS was 8.21 months in the zolbetuximab arm and 6.80 months in the placebo arm (HR, 0.687; 95% CI, 0.544–0.866; P = .0007). The median OS was 14.39 months in the zolbetuximab arm and 12.16 months in the placebo arm (HR, 0.771; 95% CI, 0.615–0.965; P = .0118).[1][Level of evidence B1]
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The phase III SPOTLIGHT trial (NCT03504397) included 565 patients with CLDN18.2-positive, HER2-negative metastatic gastroesophageal or gastric adenocarcinoma. Patients were randomly assigned to receive mFOLFOX6 and either zolbetuximab or placebo.[2]
The phase III SPOTLIGHT trial (NCT03504397) included 565 patients with CLDN18.2-positive, HER2-negative metastatic gastroesophageal or gastric adenocarcinoma. Patients were randomly assigned to receive mFOLFOX6 and either zolbetuximab or placebo.[2]
The median PFS was 10.61 months (95% CI, 8.90–12.48) in the zolbetuximab arm and 8.67 months (95% CI, 8.21–10.28) in the placebo arm (HR, 0.75; 95% CI, 0.60–0.94; P = .0066). Patients who received zolbetuximab had a reduced risk of death (HR, 0.75; 95% CI, 0.60–0.94; P = .0053).[2][Level of evidence A1]
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A subsequent combined analysis of the SPOTLIGHT and GLOW trials showed that the addition of zolbetuximab did not negatively affect health-related quality of life.[27]
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Preserved source evidence · Not medical advice