AstraZeneca presented late-stage clinical data on October 25, 2026 showing its experimental antibody drug conjugate sonesitatug vedotin (sone-ve) doubled median overall survival to 10 months versus 5 months for chemotherapy in advanced stomach cancer patients. While the trial missed its progression-free survival target, its lower 25% Claudin 18.2 biomarker threshold could double eligible patients compared to existing therapies like Astellas's Vyloy.
Sonesitatug vedotin trial results in stomach cancer
- ▪Serious side effects occurred in 36.4% of gastric cancer patients receiving sonesitatug vedotin (sone-ve) compared with 44.8% receiving chemotherapy, though stomach-related side effects were higher at 11.1% versus 6.3%
- ▪AstraZeneca's experimental drug sonesitatug vedotin (sone-ve) doubled median overall survival to 10 months compared to 5 months for standard chemotherapy in late-stage trial results presented on October 25, 2026
- ▪The late-stage study of sonesitatug vedotin (sone-ve), presented Sunday, enrolled 532 patients with advanced stomach cancer who had received at least two prior lines of treatment, reducing their risk of death by 53%
- ▪Sonesitatug vedotin (sone-ve) failed to reach statistical significance on its secondary trial endpoint of progression-free survival in advanced gastric cancer
Analyst expectations
- ▪Financial analysts expected sonesitatug vedotin (sone-ve) to demonstrate an overall survival hazard ratio of about 0.7 or lower and a survival gain of at least two months
- ▪AstraZeneca estimates peak annual sales for sonesitatug vedotin (sone-ve) between $3 billion and $5 billion, while financial analysts project sales between $1 billion and $2.2 billion
Claudin 18.2 expression threshold and eligibility
- ▪AstraZeneca's lower 25% Claudin 18.2 expression threshold could double the eligible patient population for sonesitatug vedotin (sone-ve) and support expanding its use into earlier lines of therapy
- ▪Sonesitatug vedotin (sone-ve) enrolled stomach cancer patients with a Claudin 18.2 protein biomarker threshold of at least 25%, compared to the 75% Claudin 18.2 threshold required for Astellas Pharma Inc.'s approved drug Vyloy
Rival drug IBI343
- ▪Takeda and Innovent's competing Claudin 18.2 therapy IBI343 met its progression-free survival goal in a late-stage clinical study
- ▪HSBC analysts noted that sonesitatug vedotin's (sone-ve) failure to meet its progression-free survival target complicates direct comparison with IBI343, a competing Claudin 18.2 therapy developed by Takeda and Innovent
Tagrisso and Orpathys trial in lung cancer
- ▪Late-stage trial results presented on October 25, 2026 showed combining AstraZeneca's Tagrisso with Hutchmed's Orpathys delayed disease progression by over two months and extended life by nearly five months in non-small cell lung cancer
- ▪Tagrisso and Orpathys are oral tablets that can be taken at home by patients with non-small cell lung cancer whose tumor cells overexpress specific proteins
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