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Sonesitatug vedotin reduced the risk of death by 42% in 2nd and later-line CLDN18.2-positive advanced gastric/GEJ cancers in CLARITY-Gastric01

Business Wire

Sone-Ve reduced the risk of death by 53% in 3rd and later-line setting in primary endpoint

Consistent data across CLDN18.2 expression levels supports potential for expanded use in up to 60% of patients in this setting

WILMINGTON, Del., October 25, 2026--Positive results from the CLARITY-Gastric01 global Phase III trial showed AstraZeneca's sonesitatug vedotin (Sone-Ve) demonstrated a statistically significant and highly clinically meaningful improvement in overall survival (OS) in 2nd- and later-line Claudin 18.2-positive advanced gastric cancers versus investigator's choice of therapy.

The trial included patients with locally advanced or metastatic gastric cancer, gastroesophageal junction (GEJ) cancer, or esophageal adenocarcinoma (EAC) with Claudin 18.2 (CLDN18.2) expression on at least 25% of tumor cells at any staining intensity, expanding the patient population beyond the current definition of CLDN18.2 positivity.

The results will be presented today during a Presidential Symposium at the European Society for Medical Oncology (ESMO) Congress 2026 in Madrid, Spain (abstract #LBA7).1

The trial had dual primary endpoints of OS in the 3rd- and later-line treatment setting and progression-free survival (PFS) in the overall trial population of patients treated in the 2nd- and later-line setting. OS in the overall trial population was a key secondary endpoint.

In a planned interim analysis, Sone-Ve reduced the risk of death by 42% compared to investigator's choice of therapy (based on an OS hazard ratio [HR] of 0.58; 95% confidence interval [CI] 0.47–0.73; p<0.000004) in the overall trial population. Median OS was 10.6 months for patients treated with Sone-Ve compared to 6.4 months for investigator's choice of therapy.

In the 3rd- and later-line setting, Sone-Ve reduced the risk of death by 53% compared to investigator's choice of therapy (OS HR of 0.47; 95% CI 0.36–0.62; p<0.000001). Median OS doubled for patients treated with Sone-Ve (10.0 versus 5.0 months). The OS benefit observed was consistent across most predefined subgroups in both the overall trial population and the 3rd- and later-line setting, including subgroups based on CLDN18.2 expression levels (≥25%-<75% and ≥75%).

For the other dual primary endpoint of PFS as assessed by blinded independent central review (BICR) in the overall trial population, results showed a trend toward improved PFS in patients treated in the 2nd- and later-line setting but did not reach statistical significance. An exploratory analysis of investigator-assessed PFS showed a more pronounced treatment effect (PFS HR 0.59; 95% CI 0.48-0.73) that was consistent with observed OS results in this setting.

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