AstraZeneca reports positive results from its Phase III CLARITY-Gastric01 trial, where sonesitatug vedotin (Sone-Ve) demonstrated a statistically significant overall survival benefit in patients with advanced, Claudin 18.2-positive gastric cancers. Sone-Ve is the first CLDN18.2-targeted antibody-drug conjugate to show survival improvement in this setting, offering a potential new precision treatment for a patient population with limited options and historically poor survival rates.
CLARITY-Gastric01 trial results
- ▪The CLARITY-Gastric01 trial met its dual primary endpoint of overall survival in third and later-line treatment and its key secondary endpoint of overall survival in the second and later-line setting.
- ▪The CLARITY-Gastric01 trial's dual primary endpoint of progression-free survival showed an improved trend but did not reach statistical significance.
- ▪The CLARITY-Gastric01 trial is conducted in 175 centers across 19 countries, including North America, Europe, South America, and Asia.
- ▪Sonesitatug vedotin demonstrated a statistically significant improvement in overall survival in the CLARITY-Gastric01 Phase III trial for advanced gastric cancers.
CLDN18.2 biomarker expression
- ▪An estimated 183,500 patients in the United States, European Union, China, and Japan are treated annually for advanced, Claudin 18.2-positive, non-HER2-positive gastric cancers.
- ▪Claudin 18.2 is expressed on at least 25% of tumor cells in approximately 60% of gastric and gastroesophageal junction cancers.
Gastric cancer treatment options
- ▪Median survival ranges from five to nine months for patients receiving second and later-line systemic treatments for advanced gastric cancer.
- ▪Less than 20% of patients diagnosed with advanced or metastatic gastric or gastroesophageal junction cancers survive more than one year.
Sonesitatug vedotin ADC mechanism
- ▪Sonesitatug vedotin is an antibody-drug conjugate targeting Claudin 18.2, consisting of a monoclonal antibody, a protease-degradable linker, and a monomethyl auristatin E payload.
- ▪AstraZeneca acquired the global exclusive license to develop and commercialize sonesitatug vedotin from KYM Biosciences in March 2023.
AstraZeneca GI cancer portfolio
- ▪AstraZeneca's gastrointestinal cancer portfolio includes approved therapies such as Imfinzi, Enhertu, Lynparza, and Orpathys across various indications.
- ▪AstraZeneca is evaluating sonesitatug vedotin in the CLARITY-Gastric02 Phase III trial in combination with capecitabine, with or without rilvegostomig, as a first-line treatment.
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