AstraZeneca (AZN) said Monday that its Phase 3 CLARITY-Gastric01 trial met the dual primary overall survival endpoint for sonesitatug vedotin in patients with Claudin 18.2-positive advanced gastric, gastroesophageal junction and esophageal adenocarcinoma cancers treated in the third-line and later setting.
The antibody-drug conjugate also met a key secondary endpoint, demonstrating a statistically significant and clinically meaningful improvement in overall survival in patients treated in the second-line and later setting compared with investigator's choice of therapy, the company said.
The progression-free survival co-primary endpoint showed a favorable trend but did not reach statistical significance.
AstraZeneca said no new safety signals were identified and that it plans to present the data at a future medical meeting and submit it to global regulators.