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Immunogenicity of GM-CSF products in cancer patients following immunostimulatory therapy with GM-CSF.

There is a high risk of developing neutralising and non-neutralising antibodies when GM-CSF is used as an immunomodulatory agent in non-immunocompromised patients. The presence of neutralising antibodies may seriously hamper the clinical response of the patients. This must be taken into account when designing protocols if the biological activity of the exogenously administered GM-CSF is not to be impaired and the endogenous production of GM-CSF is not to be inactivated. Assessment of production of neutralising antibodies during cytokine therapy is important for predicting the clinical response to progressive therapy. Use of validated assays is imperative for evaluation of antibodies generated following therapy with a particular protein.