阿斯利康Sone-Ve胃癌III期OS阳性、死亡风险降42%，但属ESMO旧数据详披且PFS未达标

AstraZeneca (AZN) reported positive Phase 3 results showing that sonesitatug vedotin (Sone-Ve) significantly improved overall survival in patients with CLDN18.2-positive advanced gastric, gastroesophageal junction (GEJ) and oesophageal adenocarcinoma cancers treated in the second- and later-line settings.
The findings come from the global Phase 3 CLARITY-Gastric01 trial, which evaluated Sone-Ve against investigator's choice of therapy in patients whose tumors expressed CLDN18.2 on at least 25% of tumor cells, at any staining intensity.
In a planned interim analysis, Sone-Ve reduced the risk of death by 42% compared with investigator's choice of therapy in the overall trial population.
Median overall survival (OS) was 10.6 months with Sone-Ve versus 6.4 months with the comparator treatment, extending median survival by 4.2 months.
In the third- and later-line treatment setting, Sone-Ve reduced the risk of death by 53%. Median OS doubled to 10.0 months compared with 5.0 months for investigator's choice of therapy.
The survival benefit was consistent across most predefined subgroups, including patients with different levels of CLDN18.2 expression.
The findings support the potential use of Sone-Ve in a broader patient population, as approximately 60% of gastric and GEJ cancers are estimated to express CLDN18.2 in at least 25% of tumor cells.
For the trial's other dual primary endpoint, progression-free survival (PFS) assessed by blinded independent central review, results showed a trend toward improvement but did not reach statistical significance.
Median PFS was 4.2 months with Sone-Ve versus 3.8 months with investigator's choice of therapy (HR 0.77; p=0.053193).
An exploratory analysis of investigator-assessed PFS showed a more pronounced treatment effect, with a hazard ratio of 0.59, consistent with the overall survival results.
The safety profile of Sone-Ve was manageable and consistent with its known profile, with no new safety signals identified.
Grade 3 or higher treatment-related adverse events occurred in 36.4% of patients receiving Sone-Ve compared with 44.8% in the comparator arm.
The results will be presented during a Presidential Symposium at the European Society for Medical Oncology (ESMO) Congress 2026 in Madrid, Spain.
Sone-Ve is an investigational antibody-drug conjugate targeting CLDN18.2, a protein expressed in certain gastrointestinal cancers.
AstraZeneca is evaluating the therapy in the Phase 3 CLARITY-Gastric02 trial as a first-line treatment, in combination with capecitabine, with or without rilvegostomig, for advanced or metastatic gastric, GEJ and oesophageal adenocarcinoma cancers.
The findings support further development of Sone-Ve as a potential treatment option for patients with CLDN18.2-positive advanced gastric and related cancers whose disease has progressed after earlier therapies.
AZN has traded between $153.41 and $212.71 over the past 52 weeks.
The stock closed Friday's trade at $171.49, down 0.63%.
In pre-market trading, AZN is further down 0.07% at $171.35.
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