Researchers found that patients with gastric cancer who get zolbetuximab have longer lives.
"The results of the study are important for cancer research. They show that patients with gastric cancer who have been treated with zolbetuximab live longer. The progression of the tumour disease is delayed and overall survival of patients is improved. We expect that the study will lead to the approval of this drug in Europe and as a result also in Germany. This is an important step for those affected by this serious and often fatal cancer," said Professor Florian Lordick, director of the University Cancer Center Leipzig.
The experienced oncologist helped to design the recently published study at the international level and ensured that German patients were able to participate.
A total of 565 patients were treated with zolbetuximab in conjunction with chemotherapy or a placebo and chemotherapy in this trial involving participants from 20 countries. The test substance was produced more than 10 years ago in Germany and has since been rigorously examined through all study phases until it was ready for clinical usage in patients. In the current trial, zolbetuximab with chemotherapy dramatically decreased the risk of disease progression or mortality by 25% when compared to chemotherapy alone. As a result, the study's goal was met. The most prevalent adverse events among patients were nausea, vomiting, and loss of appetite, however the side effects of zolbetuximab and chemotherapy proved to be tolerable.
Furthermore, the study establishes a new clinically relevant biomarker in gastric cancer called claudin-18 isoform 2 (CLDN18.2). This biomarker can be identified using a staining method in tumour biopsies, a procedure to remove cells or tissue from an affected area. If 75 per cent of the tumour cells stain positive for the membrane protein CLDN18.2, the drug zolbetuximab is likely to work particularly well. Zolbetuximab is given as an intravenous infusion to patients with advanced gastric cancer in combination with chemotherapy. It then docks via the bloodstream to the tumour cells carrying CLDN18.2, where it triggers an immune response that contributes to the death of the tumour cells.
"Following the introduction of trastuzumab ten years ago, this is the second targeted antibody that can prolong the survival of patients with advanced gastric cancer, and I have been privileged to play a key role in its clinical development," said Professor Lordick. (ANI)