AstraZeneca (LSE:AZN) said its antibody drug conjugate sonesitatug vedotin, known as Sone-Ve, produced a statistically significant and clinically meaningful improvement in overall survival in second and later-line CLDN18.2-positive advanced gastric and gastroesophageal junction cancers.
The Phase III CLARITY-Gastric01 trial compared the drug against investigator's choice of therapy in patients whose tumours expressed the Claudin 18.2 protein on at least 25% of cells, a threshold covering roughly 60% of patients in this setting.
The trial met both its endpoint of overall survival in third and later-line treatment and a key secondary endpoint of overall survival across the broader second and later-line population.
A separate endpoint, progression-free survival, showed a trend toward improvement but fell short of statistical significance.
Rui-Hua Xu, principal investigator on the trial, said Sone-Ve "is the first CLDN18.2-targeted antibody drug conjugate to demonstrate an overall survival benefit in this setting."
Gastric cancer is the fifth most common cancer worldwide, with nearly one million new diagnoses in 2024 and roughly 650,000 deaths, and less than 20% of advanced-stage patients survive beyond one year.
Susan Galbraith, AstraZeneca's head of oncology haematology research and development, called the results the first pivotal readout from the company's wholly owned ADC portfolio.
Sone-Ve, licensed from KYM Biosciences in March 2023, has received orphan drug status from US and European regulators and breakthrough designation in China.
The data will be presented at a forthcoming medical meeting and submitted to global regulatory authorities.
News Intelligence what this means for the company
AstraZeneca's Sone-Ve met its primary overall survival endpoint in the Phase III CLARITY-Gastric01 trial for second and later-line CLDN18.2-positive gastric cancer, becoming the first antibody drug conjugate to show such a benefit in this setting. The result marks the first pivotal readout from AstraZeneca's wholly owned ADC portfolio and addresses a disease with poor prognosis—less than 20% of advanced-stage patients survive beyond one year—in a patient population covering roughly 60% of gastric cancer cases.
A positive Phase III oncology readout strengthens AstraZeneca's ADC pipeline and adds a potential new revenue stream in gastric cancer, where unmet need is substantial. Regulatory pathway is clear: the drug already holds orphan drug status in the US and EU, and breakthrough designation in China, positioning it for expedited review.
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