AstraZeneca has reported a major clinical advance in advanced gastric cancer.

 

The pharma giant has announced that its investigational medicine sonesitatug vedotin (Sone-Ve) achieved a statistically significant and clinically meaningful improvement in overall survival in patients with CLDN18.2-positive gastric and gastroesophageal junction (GEJ) cancers.

 

Results from the global CLARITY-Gastric01 Phase III trial showed that Sone-Ve outperformed investigator’s choice of therapy in patients whose cancers had progressed after previous treatments. The study marks the first Phase III trial to demonstrate an overall survival benefit for an anti-CLDN18.2 antibody drug conjugate (ADC) in this treatment setting.

 

The findings could significantly expand the number of patients eligible for targeted therapy, with AstraZeneca estimating that allowing CLDN18.2 positivity at 25% or greater tumour expression could represent approximately 60% of patients with advanced gastric and GEJ cancers.

 

The trial met its dual primary endpoint of overall survival in patients receiving third-line and later treatment. It also achieved a key secondary endpoint, showing a statistically significant overall survival improvement across the broader population of patients treated in the second-line and later setting.

 

However, the second dual primary endpoint — progression-free survival (PFS) assessed by blinded independent central review — showed a positive trend but did not reach statistical significance.

 

Professor Rui-Hua Xu, 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 at AstraZeneca, 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.”