Immunogenicity assessment of tbo-filgrastim in cancer patients receiving chemotherapy.

This integrated analysis examined the immunogenicity of tbo-filgrastim and its potential clinical impact in three Phase Ill randomized studies in patients with breast cancer, lung cancer and non-Hodgkin lymphoma receiving chemotherapy. Results: Treatment-emergent antidrug antibodies (ADA) occurred in 3/213 (1.4%) breast cancer patients, 2/160 (1.3%) lung cancer patients and 1/63 (1.6%) patients with non-Hodgkin lymphoma. None of the treatment-emergent ADA showed cross-reactivity toward native granulocyte-colony stimulating factors or exhibited neutralizing activity against tbo-filgrastim. Among patients with treatment-emergent ADA, there was no treatment-related hypersensitivity or anaphylaxis and no evidence of loss of clinical efficacy. Conclusion: Tbo-filgrastim has demonstrated low immunogenicity in cancer patients receiving chemotherapy and ADA response does not impact safety and efficacy in the patients.