AstraZeneca has announced positive high-level results from the global Phase III CLARITY-Gastric01 trial, showing that its investigational antibody-drug conjugate sonesitatug vedotin (Sone-Ve) delivered a statistically significant and clinically meaningful improvement in overall survival for patients with CLDN18.2-positive advanced gastric, gastroesophageal junction (GEJ), and esophageal adenocarcinoma (EAC) receiving second-line or later treatment.

The trial met its dual primary endpoint of overall survival in the third-line and later setting, along with a key secondary endpoint of overall survival in the overall second-line and later patient population. Although progression-free survival showed improvement, it did not reach statistical significance.

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Rui-Hua Xu, M.D., Ph.D., Professor in the Department of Medical Oncology, Sun Yat-Sen University Cancer Center, Guangzhou, China, and principal investigator of the trial said: “Metastatic gastric cancer is an aggressive disease with very limited options once patients progress after first-line treatment. Sone-Ve is the first CLDN18.2-targeted antibody drug conjugate to demonstrate an overall survival benefit in this setting and has the potential to establish a new precision treatment for a broader population of patients with CLDN18.2 expression.”

Susan Galbraith, Executive Vice President, Oncology Haematology R&D, said: “Sone-Ve has the potential to reshape the treatment of gastric cancer by replacing classic chemotherapy with this novel targeted antibody drug conjugate to improve outcomes for patients. These transformative results from the first Phase III readout for Sone-Ve, together with our broad development programme, highlight the potential for Sone-Ve to become an important new medicine in CLDN18.2-positive cancers.”

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Sone-Ve is the first CLDN18.2-targeting antibody-drug conjugate (ADC) to demonstrate an overall survival benefit in this setting and has the potential to expand treatment to patients with CLDN18.2 expression in at least 25% of tumour cells, representing approximately 60% of patients with advanced gastric and GEJ cancers.

The investigational therapy was well tolerated, with no new safety signals identified. AstraZeneca said the results will be presented at an upcoming medical meeting and submitted to global regulatory authorities.