Evaluation of Immunogenicity of Nivolumab Monotherapy and Its Clinical Relevance in Patients With Metastatic Solid Tumors

Journal of Clinical Pharmacology

Volumn 57, Issue 3, 2017, Pages 394-400

  Agrawal, Shruti ^a   Statkevich, Paul ^a   Bajaj, Gaurav ^a   Feng, Yan ^a   Saeger, Sally ^a   Desai, Dharmesh D ^a   Park, Jong Soon ^a   Waxman, Ian M ^a   Roy, Amit ^a   Gupta, Manish ^a  

^a BRISTOL MYERS SQUIBB   (United States)

Author keywords

antidrug antibodies; immunogenicity; immunotherapy; nivolumab; pharmacokinetics; programmed death 1

Indexed keywords

NEUTRALIZING ANTIBODY; NIVOLUMAB; ANTIBODY; ANTINEOPLASTIC AGENT; MONOCLONAL ANTIBODY;

ADVANCED CANCER; ALLERGIC REACTION; ANAPHYLAXIS; ARTICLE; BRONCHOSPASM; CANCER PATIENT; CHEMOLUMINESCENCE; CONTROLLED STUDY; DRUG CLEARANCE; DRUG EFFICACY; DRUG ELIMINATION; DRUG SAFETY; DRUG SCREENING; HUMAN; HYPERSENSITIVITY; IMMUNOGENICITY; INCIDENCE; INFUSION RELATED REACTION; MAJOR CLINICAL STUDY; MONOTHERAPY; PHASE 2 CLINICAL TRIAL; PHASE 3 CLINICAL TRIAL; PREVALENCE; SOLID TUMOR; CLINICAL TRIAL (TOPIC); IMMUNOLOGY; NEOPLASMS;

ANTIBODIES; ANTIBODIES, MONOCLONAL; ANTIBODIES, NEUTRALIZING; ANTINEOPLASTIC AGENTS; CLINICAL TRIALS AS TOPIC; HUMANS; NEOPLASMS;

EID: 84994545669     PISSN: 00912700     EISSN: 15524604     Source Type: Journal    
DOI: 10.1002/jcph.818     Document Type: Article

References (21)

1. Wang C, Thudium KB, Han M, et al. In vitro characterization of the anti-PD-1 antibody nivolumab, BMS-936558, and in vivo toxicology in non-human primates. Cancer Immunol Res. 2014;2(9):846–856.
2. Bergenstal RM, Garrison LP Jr, Miller LA, et al. Exenatide BID Observational Study (ExOS): results for primary and secondary endpoints of a prospective research study to evaluate the clinical effectiveness of exenatide BID use in patients with type 2 diabetes in a real-world setting. Curr Med Res Opin. 2011;27(12):2335–2342.
3. Topalian SL, Hodi FS, Brahmer JR, et al. Safety, activity, and immune correlates of anti-PD-1 antibody in cancer. N Engl J Med. 2012;366(26):2443–2454.
4. Topalian SL, Sznol M, McDermott DF, et al. Survival, durable tumor remission, and long-term safety in patients with advanced melanoma receiving nivolumab. J Clin Oncol. 2014;32(10):1020–1030.
5. Ansell SM, Lesokhin AM, Borrello I, et al. PD-1 blockade with nivolumab in relapsed or refractory Hodgkin's lymphoma. N Engl J Med. 2014;372(4):311–319.
6. Motzer RJ, Rini BI, McDermott DF, et al. Nivolumab for metastatic renal cell carcinoma: results of a randomized phase II trial. J Clin Oncol. 2014;33(13):1430–1437.
7. Rizvi NA, Mazieres J, Planchard D, et al. Activity and safety of nivolumab, an anti-PD-1 immune checkpoint inhibitor, for patients with advanced, refractory squamous non-small-cell lung cancer (CheckMate 063): a phase 2, single-arm trial. Lancet Oncol. 2015;16(3):257–265.
8. Robert C, Long GV, Brady B, et al. Nivolumab in previously untreated melanoma without BRAF mutation. N Engl J Med. 2015;372(4):320–330.
9. Weber JS, D'Angelo SP, Minor D, et al. Nivolumab versus chemotherapy in patients with advanced melanoma who progressed after anti-CTLA-4 treatment (CheckMate 037): a randomised, controlled, open-label, phase 3 trial. Lancet Oncol. 2015;16(4):375–384.
10. van Meer PJ, Kooijman M, Brinks V, et al. Immunogenicity of mAbs in non-human primates during nonclinical safety assessment. MAbs. 2013;5(5):810–816.
11. Kuus-Reichel K, Grauer LS, Karavodin LM, Knott C, Krusemeier M, Kay NE. Will immunogenicity limit the use, efficacy, and future development of therapeutic monoclonal antibodies? Clin Diagn Lab Immunol. 1994;1(4):365–372.
12. Koren E, Zuckerman LA, Mire-Sluis AR. Immune responses to therapeutic proteins in humans-clinical significance, assessment and prediction. Curr Pharm Biotechnol. 2002;3(4):349–360.
13. Wolbink GJ, Aarden LA, Dijkmans BA. Dealing with immunogenicity of biologicals: assessment and clinical relevance. Curr Opin Rheumatol. 2009;21(3):211–215.
14. Yanai H, Hanauer SB. Assessing response and loss of response to biological therapies in IBD. Am J Gastroenterol. 2011;106(4):685–698.
15. Brahmer J, Reckamp KL, Baas P, et al. Nivolumab versus docetaxel in advanced squamous-cell non-small-cell lung cancer. N Engl J Med. 2015;373(2):123–135.
16. Borghaei H, Paz-Ares L, Horn L, et al. Nivolumab versus docetaxel in advanced nonsquamous non-small-cell lung cancer. N Engl J Med. 2015;373(17):1627–1639.
17. Larkin J, Chiarion-Sileni V, Gonzalez R, et al. Combined nivolumab and ipilimumab or monotherapy in untreated melanoma. N Engl J Med. 2015;373(1):23–34.
18. US Food and Drug Administration. Guidance for industry: assay development for immunogenicity testing of therapeutic proteins. Rockville, MD: US Food and Drug Administration; 2009.
19. US Food and Drug Administration. Guidance for industry: immunogenicity assessment for therapeutic protein products. Rockville, MD: US Food and Drug Administration; 2014.
20. Scheinfeld N. A comprehensive review and evaluation of the side effects of the tumor necrosis factor alpha blockers etanercept, infliximab and adalimumab. J Dermatol Treat. 2004;15(5):280–294.
21. Korswagen LA, Bartelds GM, Krieckaert CL, et al. Venous and arterial thromboembolic events in adalimumab-treated patients with antiadalimumab antibodies: a case series and cohort study. Arthritis Rheum. 2011;63(4):877–883.