AstraZeneca drug shows survival benefit in gastric cancer trial

AstraZeneca (NASDAQ: AZN) reported positive high-level results from the CLARITY-Gastric01 global Phase III trial, showing that sonesitatug vedotin (Sone-Ve) demonstrated a statistically significant improvement in overall survival in patients with Claudin 18.2-positive advanced gastric cancers in the 2nd and later-line treatment setting.

The trial included patients with locally advanced or metastatic gastric cancer, gastroesophageal junction cancer, or oesophageal adenocarcinoma with Claudin 18.2 expression on at least 25% of tumor cells. The trial had dual primary endpoints: overall survival in 3rd and later-line treatment and progression-free survival in the overall trial population.

The trial met the primary endpoint of overall survival in 3rd and later-line treatment, as well as a key secondary endpoint of overall survival in the broader 2nd and later-line population. Results for the progression-free survival endpoint showed a trend toward improvement but did not reach statistical significance.

Sone-Ve is described as a CLDN18.2-targeting antibody drug conjugate with a monomethyl auristatin E payload. The company said the drug was well tolerated with no new safety signals identified.

Sone-Ve has received Orphan Drug Designation from the U.S. Food and Drug Administration and the European Commission for gastric and gastroesophageal junction cancers, and Breakthrough Designation in China for 2nd-line gastric cancer treatment.

AstraZeneca said the data will be presented at a forthcoming medical meeting and shared with global regulatory authorities.

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