AstraZeneca has reported promising Phase III clinical trial results for sonesitatug vedotin (Sone-Ve), an antibody-drug conjugate (ADC) developed to treat advanced gastric cancer. The drug reduced the risk of death by 42% among previously treated patients with Claudin 18.2 (CLDN18.2)-positive advanced gastric and gastroesophageal junction (GEJ) cancers. The results mark a significant milestone in AstraZeneca’s efforts to expand its targeted cancer therapy portfolio, particularly in gastrointestinal cancers.
Sone-Ve Improves Overall Survival in Phase III Trial
In the CLARITY-Gastric01 Phase III trial, patients treated with Sone-Ve achieved a median overall survival of 10.6 months, compared with 6.4 months among those receiving the investigator’s choice of treatment. The results corresponded to a hazard ratio of 0.58, indicating a 42% reduction in the risk of death compared with the control group. Moreover, the benefits were more pronounced among patients receiving treatment in the third-line setting or later. In this group, Sone-Ve reduced the risk of death by 53%, with median overall survival reaching 10 months, compared with five months for the comparator group. The 12-month survival rate also improved. Approximately 42.6% of patients receiving Sone-Ve remained alive after one year, compared with 27.8% of patients receiving the alternative treatment.
AstraZeneca Expands Its Gastrointestinal Cancer Pipeline
AstraZeneca licensed Sone-Ve from KYM Biosciences in 2023. Following the latest results, the company continues to investigate the drug across several gastrointestinal cancers. The ongoing development programme includes a Phase III trial evaluating Sone-Ve as a first-line treatment for gastric cancer, alongside Phase II trials in CLDN18.2-positive pancreatic and biliary tract cancers. Additionally, AstraZeneca recently announced a clinical collaboration with Summit Therapeutics to evaluate Sone-Ve in combination with ivonescimab. These programmes reflect the company’s broader strategy to develop targeted therapies that address specific molecular characteristics of cancer cells.
Multiple Targeted Approaches Strengthen Cancer Research
Beyond Sone-Ve, AstraZeneca is advancing several other cancer treatment programmes. Its pipeline includes a Claudin 18.2-targeting T-cell engager licensed from Harbour Biomed, a pan-KRAS inhibitor programme licensed from Jacobio, and an engineered CAR T-cell therapy designed for liver cancer. Meanwhile, Enhertu, which AstraZeneca develops in partnership with Daiichi Sankyo, is already approved for HER2-positive advanced gastric cancer in relevant markets. Together, these programmes demonstrate AstraZeneca’s focus on developing therapies that target distinct cancer biomarkers and biological pathways.
Clinical Results Support Further Development
The CLARITY-Gastric01 findings strengthen the clinical case for Sone-Ve in previously treated CLDN18.2-positive advanced gastric and GEJ cancers. The survival improvements, particularly in patients receiving third-line or later treatment, highlight its potential in a disease setting where treatment options can be limited. As reported by beckersoncology.com, as AstraZeneca advances its clinical programmes, further research will help establish the drug’s role across different treatment lines and gastrointestinal cancer types.