What are the results of clinical trials of zotuximab in gastric cancer?

Zolbetuximab is a targeted drug, an anti-CLDN18.2 antibody, mainly used to treat gastric cancer, especially CLDN18.2-positive gastric cancer. CLDN18.2 is an intercellular junction protein that is usually highly expressed in gastric cancer and is closely related to tumor occurrence and progression. Zotuximab can promote the immune system's recognition and killing of tumor cells by binding to and inhibiting CLDN18.2, and has the potential to become an important drug in the treatment of gastric cancer.

In multiple clinical trials, zotuximab (VYLOY) has shown good efficacy and good safety. Especially in the FLAURA2 trial, zotuximab combined with chemotherapy (such as paclitaxel and platinum drugs) was used to treat patients with metastatic gastric cancer or gastroesophageal junction cancer. The results showed that zotuximab combined with chemotherapy can significantly extend the progression-free survival (PFS) and overall survival (OS) of patients. In this trial, the efficacy of zotuximab was better than that of traditional chemotherapy regimens, especially in CLDN18.2-positive patients, showing a higher response rate.

In addition, zotuximab monotherapy has also achieved positive results in CLDN18.2-positive gastric cancer patients. According to clinical data, about 40% to 50% of gastric cancer patients express CLDN18.2, and these patients usually have poor response to traditional treatments. The application of zotuximab has enabled some patients to obtain effective treatment responses. Some patients have significantly prolonged survival after receiving treatment, and the side effects of treatment are relatively controllable, mainly including mild immune-related adverse reactions, such as fever and chills.
In summary, VYLOY (zotuximab) has shown positive efficacy in clinical trials of gastric cancer. Especially in CLDN18.2-positive patients, combination with chemotherapy can significantly improve the treatment effect. With further clinical validation, zotuximab is expected to become a breakthrough drug in the treatment of gastric cancer, especially for patients who have poor response to traditional treatments.
Reference: https://www.astellas.com/en/news/29401