AstraZeneca’s Sone-Ve cuts death risk in Phase III gastric cancer trial
AstraZeneca reported on October 25 that Sone-Ve met its overall-survival endpoint in the Phase III CLARITY-Gastric01 trial presented at the ESMO Congress. In patients treated in the third line and later, Sone-Ve reduced the risk of death by 53% and produced median overall survival of 10.0 months versus 5.0 months for investigator’s choice. In the broader second-line-and-later population, death risk fell 42%, with median overall survival of 10.6 months versus 6.4 months, while blinded-review progression-free survival did not reach statistical significance.
Why it matters
AstraZeneca is preparing a regulatory filing for Sone-Ve, creating a potential path toward approval in previously treated CLDN18.2-positive gastric cancers. The overall-survival result supports the filing, but the progression-free-survival miss remains a consideration for regulatory and commercial assessment.
Key facts
- 1In the third-line-and-later population, Sone-Ve produced median overall survival of 10.0 months versus 5.0 months for investigator’s choice, with a hazard ratio of 0.47 and p<0.000001. stocktitan.net
- 2In the overall second-line-and-later population, median overall survival was 10.6 months with Sone-Ve versus 6.4 months with investigator’s choice, with a hazard ratio of 0.58 and p<0.000004. stocktitan.net
- 3Blinded independent central review showed median progression-free survival of 4.2 months versus 3.8 months, with a hazard ratio of 0.77 and p=0.053193, which did not reach statistical significance. stocktitan.net
- 4AstraZeneca said the Sone-Ve dataset was robust enough to support taking the drug to regulators. marketscreener.com
Open questions
- Patient-count reporting differs, with one account giving 545 patients and other reporting giving 532.
- Reports differ on whether progression-free survival met a primary endpoint; the detailed trial results say blinded-review progression-free survival did not reach statistical significance, while another summary says the trial met primary endpoints.
Summary written by AlphAI AI Desk from 11 of 11 sources. Not investment advice. Figures are as stated by the linked sources.