AstraZeneca said its experimental drug extended survival in a Phase III stomach cancer trial
AstraZeneca said its investigational drug sonesitatug vedotin (Sone-Ve) improved overall survival in a Phase III trial of advanced, CLDN18.2-positive stomach cancer after prior treatment. Median survival was 10.6 months, versus 6.4 months with investigator’s choice, and death risk fell 42%. Fierce Biotech reported that the trial missed its progression-free-survival endpoint, while AstraZeneca said it was discussing results with regulators.
More context
AstraZeneca said its investigational antibody-drug conjugate sonesitatug vedotin (Sone-Ve) significantly improved overall survival in the Phase III CLARITY-Gastric01 trial among patients with advanced, CLDN18.2-positive stomach cancer. At an interim analysis of patients receiving second- or later-line treatment, Sone-Ve reduced the risk of death by 42% compared with investigator’s choice of therapy (hazard ratio 0.58). Median overall survival was 10.6 months with Sone-Ve and 6.4 months with the comparator; the analysis included 267 and 265 patients, respectively. The results were scheduled for presentation at the European Society for Medical Oncology Congress in Madrid on Oct. 25. Fierce Biotech reported that the trial missed a key progression-free-survival endpoint. Susan Galbraith, AstraZeneca’s executive vice president of oncology hematology R&D, said the company was discussing the overall-survival results with regulators and thought it was in a good position.
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Reporting
- Bloomberg — Astra’s Experimental Stomach Cancer Drug Doubled Survival Time - Bloomberg
- Seeking Alpha — AstraZeneca stomach cancer drug doubles survival in late-stage trial (AZN:NYSE) | Seeking Alpha
- securities.io — Sone-Ve Cuts Death Risk 42% in Phase III Gastric Cancer Trial – Securities.io
- fiercebiotech.com — ESMO: AZ exec insists ph. 3 ADC data ‘robust’ despite PFS miss
- wtaq.com — AstraZeneca’s stomach cancer drug clears bar for extending overall survival in late-stage study
- investingnews.com — Sonesitatug vedotin reduced the risk of death by 42% in 2nd and later-line CLDN18.2-positive advanced gastric/GEJ cancers in CLARITY-Gastric01
Verifier’s note
The results report that AstraZeneca’s late-stage Sone-Ve trial improved overall survival in advanced stomach cancer, matching the proposed event. The reports are current and do not contradict its central claim.