van Brummelen EMJ, Ros W, Wolbink G, Beijnen JH, Schellens JHM. Antidrug antibody formation in oncology: clinical relevance and challenges. Oncologist. 2016;21(10):1260–8.
Article PubMed PubMed Central Google Scholar
Research C for DE and. Immunogenicity Assessment for Therapeutic Protein Products [Internet]. FDA; 2020 [cited 2024 Feb 2]. Available from: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/immunogenicity-assessment-therapeutic-protein-products.
Research C for DE and. Immunogenicity Testing of Therapeutic Protein Products —Developing and Validating Assays for Anti-Drug Antibody Detection [Internet]. FDA; 2020 [cited 2024 Feb 2]. Available from: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/immunogenicity-testing-therapeutic-protein-products-developing-and-validating-assays-anti-drug.
Mire-Sluis AR, Barrett YC, Devanarayan V, Koren E, Liu H, Maia M, et al. Recommendations for the design and optimization of immunoassays used in the detection of host antibodies against biotechnology products. J Immunol Methods. 2004;289(1–2):1–16.
Article CAS PubMed Google Scholar
Koren E, Smith HW, Shores E, Shankar G, Finco-Kent D, Rup B, et al. Recommendations on risk-based strategies for detection and characterization of antibodies against biotechnology products. J Immunol Methods. 2008;333(1–2):1–9.
Article CAS PubMed Google Scholar
Shankar G, Arkin S, Cocea L, Devanarayan V, Kirshner S, Kromminga A, et al. Assessment and reporting of the clinical immunogenicity of therapeutic proteins and peptides-harmonized terminology and tactical recommendations. AAPS J. 2014;16(4):658–73.
Article CAS PubMed PubMed Central Google Scholar
Immunogenicity assessment of biotechnology-derived therapeutic proteins - Scientific guideline | European Medicines Agency [Internet]. [cited 2024 Feb 2]. https://www.ema.europa.eu/en/immunogenicity-assessment-biotechnology-derived-therapeutic-proteins-scientific-guideline.
genentech-medinfo [Internet]. [cited 2024 Feb 2]. Tecentriq® (atezolizumab) | Genentech Prescribing & Product Information. https://www.genentech-medinfo.com/our-products/oncology/tecentriq.html.
Narayanan S, Guder WG. Preanalytical variables and their influence on the quality of laboratory results. EJIFCC. 2001;13(1):9–12.
PubMed PubMed Central Google Scholar
Rittmeyer A, Barlesi F, Waterkamp D, Park K, Ciardiello F, von Pawel J, et al. Atezolizumab versus Docetaxel in patients with previously treated non-small-cell lung cancer (OAK): a phase 3, open-label, multicentre randomised controlled trial. Lancet Lond Engl. 2017;389(10066):255–65.
Stroh M, Winter H, Marchand M, Claret L, Eppler S, Ruppel J, et al. Clinical pharmacokinetics and pharmacodynamics of Atezolizumab in metastatic urothelial carcinoma. Clin Pharmacol Ther. 2017;102(2):305–12.
Article CAS PubMed Google Scholar
Wu B, Sternheim N, Agarwal P, Suchomel J, Vadhavkar S, Bruno R, et al. Evaluation of atezolizumab immunogenicity: clinical pharmacology (part 1). Clin Transl Sci. 2022;15(1):130–40.
Article CAS PubMed Google Scholar
Allelic Variation in HLA-DRB1 is Associated with Development of Anti-Drug Antibodies in Cancer Patients Treated with Atezolizumab that are Neutralizing in Vitro - Google Search [Internet]. [cited 2024 Feb 2]. Available from: https://www.google.com/search?q=Allelic+Variation+in+HLA-DRB1+is+Associated+with+Development+of+Anti-Drug+Antibodies+in+Cancer+Patients+Treated+with+Atezolizumab+that+are+Neutralizing+in+Vitro&rlz=1C5GCEA_enUS1088US1088&oq=Allelic+Variation+in+HLA-DRB1+is+Associated+with+Development+of+Anti-Drug+Antibodies+in+Cancer+Patients+Treated+with+Atezolizumab+that+are+Neutralizing+in+Vitro&gs_lcrp=EgZjaHJvbWUyBggAEEUYOTIGCAEQRRhA0gEHMTE0ajBqMagCALACAA&sourceid=chrome&ie=UTF-8.
Peters S, Galle PR, Bernaards CA, Ballinger M, Bruno R, Quarmby V, et al. Evaluation of atezolizumab immunogenicity: efficacy and safety (part 2). Clin Transl Sci. 2022;15(1):141–57.
Article CAS PubMed Google Scholar
Presence and impact of antidrug antibodies (ADAs) to tremelimumab (T) or durvalumab (D) in the phase 3 HIMALAYA study of unresectable hepatocellular carcinoma (uHCC). | Journal of Clinical Oncology [Internet]. [cited 2024 Feb 2]. Available from: https://doi.org/10.1200/JCO.2023.41.4_suppl.551.
Avelumab Maintenance Therapy for Advanced or Metastatic Urothelial Carcinoma. | NEJM [Internet]. [cited 2024 Feb 2]. https://www.nejm.org/doi/full/https://doi.org/10.1056/NEJMoa2002788.
Myler H, Pedras-Vasconcelos J, Phillips K, Hottenstein CS, Chamberlain P, Devanaryan V, et al. Anti-drug antibody validation testing and reporting harmonization. AAPS J. 2022;24(1):4.
van Vugt MJH, Stone JA, De Greef RHJMM, Snyder ES, Lipka L, Turner DC, et al. Immunogenicity of pembrolizumab in patients with advanced tumors. J Immunother Cancer. 2019;7(1):212.
Article PubMed PubMed Central Google Scholar
Kim J, Kim MG, Lim KM. Participation in and withdrawal from cancer clinical trials: a survey of clinical research coordinators. Asia-Pac J Oncol Nurs. 2022;9(4):197–201.
Article PubMed PubMed Central Google Scholar
Lloyd J, Nordblad B, Sahu KKK, Swami U, Phunrab TK, Batten JA, et al. Investigating documented reasons for withdrawal from clinical trials for patients with advanced prostate cancer (PCa). J Clin Oncol. 2023;41(6suppl):105–105.
Alonso-García M, Sánchez-Gastaldo A, Muñoz-Fuentes MA, Molina-Pinelo S, Boyero L, Benedetti JC, et al. Real-world analysis of Nivolumab and Atezolizumab efficacy in previously treated patients with advanced non-small cell lung cancer. Pharm Basel Switz. 2022;15(5):533.
Agrawal S, Statkevich P, Bajaj G, Feng Y, Saeger S, Desai DD, et al. Evaluation of immunogenicity of nivolumab monotherapy and its clinical relevance in patients with metastatic solid tumors. J Clin Pharmacol. 2017;57(3):394–400.
Article CAS PubMed Google Scholar
Enrico D, Paci A, Chaput N, Karamouza E, Besse B. Antidrug antibodies against immune checkpoint blockers: impairment of drug efficacy or indication of Immune activation? Clin Cancer Res off J Am Assoc Cancer Res. 2020;26(4):787–92.
Bots SJ, Parker CE, Brandse JF, Löwenberg M, Feagan BG, Sandborn WJ, et al. Anti-drug antibody formation against biologic agents in inflammatory bowel disease: a systematic review and meta-analysis. BioDrugs. 2021;35(6):715–33.
Article CAS PubMed PubMed Central Google Scholar
Galle P, Finn RS, Mitchell CR, Ndirangu K, Ramji Z, Redhead GS, et al. Treatment-emergent antidrug antibodies related to PD-1, PD-L1, or CTLA-4 inhibitors across tumor types: a systematic review. J Immunother Cancer. 2024;12(1):e008266.
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