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Two trials that made Claudin 18.2 the third biomarker in stomach cancer, adding about two to three months of survival with an antibody against it.
SPOTLIGHT: PFS 10.6 vs 8.7 months, OS 18.2 vs 15.5 months. GLOW: PFS 8.2 vs 6.8, OS 14.4 vs 12.2 months. About 38% of screened patients were CLDN18.2-positive at the ≥75% threshold. FDA approval 18 October 2024 (Vyloy), first CLDN18.2-directed therapy. Nausea and vomiting, on-target from gastric mucosa, are frequent and front-loaded.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Overall survival (SPOTLIGHT) | Zolbetuximab + mFOLFOX6 | - | 18.2 months | - | - | link |
| Placebo + mFOLFOX6 | - | 15.5 months | ||||
| Overall survival (GLOW) | Zolbetuximab + CAPOX | - | 14.4 months | - | - | link |
| Placebo + CAPOX | - | 12.2 months |
Shares Yoon-Koo Kang, Kohei Shitara, Claudin 18.2-positive gastric cancer, Claudin 18.2.
Shares Zolbetuximab, Astellas, Oxaliplatin, Capecitabine.
Shares Zolbetuximab, Astellas, Oxaliplatin, Monoclonal antibodies.
Shares Zolbetuximab, Claudin 18.2-positive gastric cancer, Claudin 18.2, Gastric & gastro-oesophageal junction cancer.
Shares Zolbetuximab, Claudin 18.2-positive gastric cancer, Oxaliplatin, Capecitabine.
Shares Claudin 18.2-positive gastric cancer, Claudin 18.2, Astellas, Gastric & gastro-oesophageal junction cancer.
Shares CLDN18.2 antibody first line → CLDN18.2 ADC or CAR-T on progression, Claudin 18.2, Gastric & gastro-oesophageal junction cancer.
Shares CAPOX (capecitabine, oxaliplatin), Oxaliplatin, Capecitabine, Gastric & gastro-oesophageal junction cancer.