Clinical Trials Validate Zolbetuximab’s Effectiveness Against Gastric Cancer

In Germany, around 17,000 individuals suffer from gastric cancer every year. The condition ranks as one of the most common causes of and cancer-related deaths. Late diagnosis and how quickly the tumor cells metastasize can explain this phenomenon.

In two international clinical trials, a team of scientists including experts from the University of Leipzig Medical Center studied the compound that is able to increase survival of patients.

Thanks to the data published recently, zlbetuximab drug has been authorized in Europe as ready to use in clinical practice. It is expected that patients suffering from gastric cancer in Germany will be able to get this drug by the end of this year.

The results were published in the New England Journal of Medicine. The results of these trials are of great significance for all cancer research. They prove that patients suffering from the advanced stage of the gastric carcinoma and treated with zolbetuximab live longer.

The course of the disease is prolonged. This is a significant development for those patients, who battle this severe and frequently deadly cancer,” notes Professor Florian Lordick, Director of the University Cancer Center Leipzig.

The eminent clinician- oncologist was part of the global network for the coordination of the studies, which were recently published, and made certain that patients from Germany were recruited into the studies.

Zolbetuximab drug was one of the first drugs that we could do in clinical trials at the University of Leipzig Medical Center. The clinical outcomes of a number of patients with advanced gastric cancer we did improve.

Now we are very glad that after large phase III studies targeted therapy using zolbetuximab has been registered in Europe, says lordick Professor. In both studies referenced above, 1068 patients from all over the world received either zolbetuximab or placebo.

The data exhibits that patients with advanced gastric cancer who were administered with zolbetuximab combined with chemotherapy lived longer than patients who were given chemotherapy alone. In the aforementioned study, there was a 29 percent decrease in risk of progression of the disease and mortality from whatever cause during treatment with combined chemotherapy and zolbetuximab.

All the participants enrolled in the trials were diagnosed with gastric cancer expressing a high amount of claudin 18.2 protein.

Zolbetuximab is an artificial antibody created against claudin 18.2 class of proteins. There is claudin 18.2 overexpression in gastric cancers in one-third of the patients, however, it is mostly absent from normal tissue apart from the stomach and hence, it is an ideal target for such therapies.

The substance zolbetuximab which is a monoclonal antibody to claudin 18.2 was synthesized over ten years in Germany and has been used in research in all phases of trials on human squamous cell carcinoma.

It is intended for use by means of intravenous infusion in combination with chemotherapy for the treatment of advanced gastric carcinoma. The administered toxin is directed to the c18. 2 expressing tumor cells, where it selectively binds to the surface of these cells and induces an immune response that ultimately destroys all malignancies.

Reference : Kohei Shitara et al, Zolbetuximab in Gastric or Gastroesophageal Junction Adenocarcinoma, New England Journal of Medicine (2024). 

DOI: 10.1056/NEJMc2409512

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