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AZ reported P-III (CLARITY-Gastric01) data evaluating Sonesitatug vedotin (Sone-Ve; 2.2 or 1.8mg/kg, Q3W) vs investigator’s choice in 2L & later-line therapy for advanced or metastatic gastric, GEJ, or EAC with CLDN18.2 expression in ≥25% of tumour cells by IHC at any intensity
Stage 2 continued with 2.2mg/kg as the recommended dose, with the trial meeting its dual 1EP of improved OS in 3L+ treatment & 2EP of OS in the overall 2L+ population. Other dual 1EP of PFS showed a positive trend but did not reach statistical significance
Sone-Ve is also being evaluated in the P-III (CLARITY-Gastric02) trial with capecitabine ± rilvegostomig in 1L advanced or metastatic gastric, GEJ, & EAC, while P-II studies assess combinations in solid tumours, incl. CLDN18.2-positive pancreatic & BTC
Ref: AstraZeneca | Image: AstraZeneca | Press Release
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