Biopharmaceutical company AstraZeneca PLC (LSE: AZN) (STO: AZN) (NYSE: AZN) on Monday reported positive high-level results from the Phase III CLARITY-Gastric01 trial, with sonesitatug vedotin (Sone-Ve) delivering a statistically significant and highly clinically meaningful improvement in overall survival for patients with Claudin 18.2-positive advanced gastric, gastroesophageal junction and oesophageal adenocarcinoma cancers receiving second and later-line treatment.
The trial met its dual primary endpoint of overall survival in third and later-line treatment and a key secondary endpoint of overall survival in the overall second and later-line population. Progression-free survival showed an improving trend but did not achieve statistical significance.
AstraZeneca said the results support expanding CLDN18.2 positivity to patients with at least 25% tumour cell expression, representing around 60% of patients in this setting. Sone-Ve was well tolerated with no new safety signals identified.
The data will be presented at a forthcoming medical meeting and submitted to global regulatory authorities.
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