Clinical TrialJul 27, 2026, 07:01 AM
AstraZeneca Sone-Ve improves survival in gastric cancers
AI Summary
AstraZeneca announced positive high-level results from the CLARITY-Gastric01 global Phase III trial for Sonesitatug vedotin (Sone-Ve). The trial demonstrated a statistically significant and highly clinically meaningful improvement in overall survival for patients with 2nd and later-line CLDN18.2-positive advanced gastric/GEJ cancers. This marks the first Phase III trial to show an overall survival benefit with an anti-CLDN18.2 antibody drug conjugate in this setting, potentially expanding treatment options for approximately 60% of patients.
Key Highlights
- Sone-Ve demonstrated statistically significant and clinically meaningful overall survival improvement.
- Trial met dual primary endpoint of OS in 3rd and later-line CLDN18.2-positive gastric cancers.
- Met key secondary endpoint of OS in the overall 2nd and later-line trial population.
- Results allow expansion of CLDN18.2 positivity to ≥25% expression, covering ~60% of patients.
- CLARITY-Gastric01 is the first Phase III trial to show OS benefit with an anti-CLDN18.2 ADC.
- Sone-Ve was well tolerated with a consistent safety profile and no new safety signals.
- Sone-Ve received Orphan Drug Designation from US FDA and European Commission.
- Received Breakthrough Designation in China for 2nd-line gastric cancer treatment.
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