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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

$AZNPress releaseOct 25, 2026, 11:35 AM ETRead the release

AstraZeneca's Phase III CLARITY-Gastric01 trial showed sonesitatug vedotin (Sone-Ve) cut the risk of death by 42% versus investigator's choice of chemotherapy in 2nd- and later-line CLDN18.2-positive advanced gastric/GEJ cancer, with median OS of 10.6 vs 6.4 months. In the 3rd- and later-line setting, the primary endpoint, death-risk reduction was 53%, with median OS doubled to 10.0 vs 5.0 months, and benefit was consistent across CLDN18.2 expression levels — supporting use in up to ~60% of these patients.

Key figures

Drug Name
Sonesitatug vedotin (Sone-Ve)
Phase Of Trial
Phase 3
Trial name
CLARITY-Gastric01
Os hazard ratio 3 L
0.47 (95% CI 0.36-0.62)
Median os 3 L months
10.0 vs 5.0
Eligible patient pool
~60% of gastric/GEJ cancers express CLDN18.2
Death risk reduction 3 L
53%
Os hazard ratio overall
0.58 (95% CI 0.47-0.73)
Median os overall months
10.6 vs 6.4
Death risk reduction overall
42%

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