Immunogenicity assessment of tbo-filgrastim in cancer patients receiving chemotherapy-Reference-Cited by-同舟云学术

Immunogenicity assessment of tbo-filgrastim in cancer patients receiving chemotherapy

Published:2018-08-01 Issue:15 Volume:10 Page:1221-1228
ISSN:1757-6180
Container-title:Bioanalysis
language:en
Short-container-title:Bioanalysis

Author:

Zou Linglong¹,Buchner Anton²,Field Jodie A¹,Barash Steve³,Liu Patrick M¹

Affiliation:

1. Biologics Assays & Technology, Teva Pharmaceuticals Inc., West Chester, PA 19380, USA

2. Clinical Development, Merckle GmbH, Ulm, Germany

3. Global Statistics, Teva Pharmaceuticals Inc., West Chester, PA, USA

Abstract

Aim: This integrated analysis examined the immunogenicity of tbo-filgrastim and its potential clinical impact in three Phase III 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.

Publisher

Future Science Ltd

Subject

Medical Laboratory Technology,Clinical Biochemistry,General Pharmacology, Toxicology and Pharmaceutics,General Medicine,Analytical Chemistry

Link

http://www.future-science.com/doi/pdf/10.4155/bio-2018-0071

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