AstraZeneca Defends Sone-Ve Filing Case After Gastric Cancer PFS Miss
- Phase 3 CLARITY-Gastric01 tested the claudin 18.2 ADC sonesitatug vedotin in previously treated CLDN18.2-positive gastric cancer; it met its overall survival primary endpoint in third-line and later patients.
- The progression-free survival endpoint showed a favorable trend in the broader second-line-and-later population but was not statistically significant.
- An AstraZeneca executive told Fierce at ESMO that the dataset is robust enough for regulators; the company also floated broadening the positivity cutoff.
💡 Points Based on public reports
An OS win with a PFS miss is a defensible filing in a cancer where survival is the endpoint regulators and payers care about most, but the second-line label is now a negotiation rather than a given. With Takeda's rival ADC posting a clean dual win, AstraZeneca's first-mover claim in claudin 18.2 looks less secure than it did in July.
ESMO: AstraZeneca exec insists phase 3 ADC data 'robust' enough for regulators despite PFS miss ↗