Zotuximab can be used for up to several years, and how safe is it?

Zolbetuximab(zolbetuximab-clzb) is a new targeted immunotherapy drug for CLDN18.2-positive gastric cancer and gastroesophageal junction adenocarcinoma, and its duration and safety have attracted much attention. Since zotuximab is relatively new, current clinical trials and long-term post-marketing follow-up data are still in the accumulation stage, and there is no unified conclusion on the exact maximum period of use. However, existing research and clinical experience can provide important reference for its safe use.

Judging from the current clinical trial data, zotuximab is usually used as a treatment option for patients with advanced gastric cancer, and the treatment cycle is mostly adjusted based on the patient's tolerance and persistence of efficacy. Most patients show good tumor control effects after receiving several cycles of treatment, and some patients can continue to receive this drug for several months to more than a year. The maximum time of use depends on the progression of the disease and the individual response of the patient. If the tumor continues to be sensitive to treatment and there are no serious adverse reactions, treatment can be continued for a longer period of time. However, if tumor progression or intolerable side effects occur, the medication is usually stopped or the treatment plan is adjusted.

In terms of safety, zotuximab is generally well tolerated. Its most common side effects include injection-related reactions such as fever, chills, rash, and fatigue, which often occur early in treatment and can be relieved by medication adjustments or symptomatic management. Because zotuximab activates the immune system to fight tumors, a small number of patients may experience immune-related adverse events, such as enteritis, pneumonia, or liver function abnormalities, but the incidence of these side effects is low and mostly controllable. As treatment lasts longer, it is especially important to monitor immune-related side effects to avoid serious health risks.

Regarding long-term safety, there is currently insufficient long-term large-scale study data to clarify the specific risks of zotuximab after several years of use. However, current international experience shows that similar immune checkpoint inhibitors do not show cumulative serious toxicity in long-term use. The long-term management of patients mainly relies on regular monitoring and timely intervention of adverse reactions. In actual clinical practice, doctors will weigh the continuity and safety of treatment according to the patient's specific situation, and adjust the treatment plan in a timely manner to ensure that the patient gets the maximum benefit.

Reference materials:https://www.astellas.com/en/news/29401