AstraZeneca says phase 3 ADC shows strong overall survival despite missing progression-free survival endpoint

AstraZeneca executives emphasized that the detailed data from their phase 3 study of the next‑generation antibody‑drug conjugate are robust enough to be presented to regulators, even though the trial did not meet a key efficacy endpoint.

The study evaluated sonesitatug vedotin (sone‑ve) in 594 patients with second‑line or later advanced or metastatic Claudin 18.2‑positive gastroesophageal carcinoma.

Results showed a median overall survival of about 10 months for patients receiving sone‑ve, roughly double the five months observed with investigator’s choice therapy. In the intent‑to‑treat population, median overall survival was 10.6 months versus 6.4 months for control. Median progression‑free survival was 4.2 months for sone‑ve compared with 3.8 months for the comparator.

Susan Galbraith, head of oncology‑hematology R&D, highlighted the robustness of the overall survival benefit and indicated the company will move forward with regulatory discussions based on the data.