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Patient outcomes improved significantly with sonesitatug vedotin in the phase 3 CLARITY-Gastric01 trial for CLDN18.2-positive gastric cancer. The trial tested the antibody-drug conjugate (ADC) in patients with tumors carrying the CLDN18.2 protein.

The international study included people with advanced or metastatic stomach cancer, GEJ cancer, and esophageal adenocarcinoma. All participants had gone through at least one round of treatment that had stopped working.

According to the report, sonesitatug vedotin demonstrated a statistically significant improvement in overall survival. The survival benefit held across two groups: patients who had tried at least two prior treatments, and a broader group who had tried at least one.

Dr. Rui-Hua Xu, principal investigator of the trial, said, “Metastatic gastric cancer is an aggressive disease with very limited options once patients progress after first-line treatment. Sone-Ve is the first CLDN18.2-targeted antibody drug conjugate to demonstrate an overall survival benefit in this setting and has the potential to establish a new precision treatment for a broader population of patients with CLDN18.2 expression.”

Susan Galbraith, executive vice president of oncology research and development at AstraZeneca, said the findings suggest the drug could provide a targeted alternative to conventional chemotherapy for some patients.

The study took place at 175 hospitals in 19 countries across North America, Europe, South America, and Asia. Everyone enrolled had a tumor that tested positive for CLDN18.2 on at least 25% of cancer cells.

The trial ran in two stages. In the first stage, patients were randomly split into three groups. One received a higher dose of sonesitatug vedotin (2.2 mg/kg) every three weeks, another received a lower dose (1.8 mg/kg) on the same schedule, and the third received the treatment their doctor thought was best.

Once researchers determined the 2.2 mg/kg as the preferred dose, patients enrolling in the trial’s second stage received that dose. They also used results from the trial to evaluate a lab test called the Ventana SP455 assay, designed to identify which patients have enough CLDN18.2 in their tumors to benefit from this kind of treatment.

AstraZeneca stated that the safety profile was consistent with earlier studies, and no new safety concerns were identified. The drug has received orphan drug designation from the U.S. Food and Drug Administration and the European Commission and breakthrough therapy designation in China for certain patients with advanced gastric cancer.

Full results from the trial will be presented at an upcoming medical conference and submitted to health regulators around the world. As the trial’s findings are further analyzed, it is possible that sonesitatug vedotin could become a viable treatment option for patients with CLDN18.2-positive gastric cancer, potentially improving outcomes for those with limited treatment options.

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