Mechanism of action of the trastuzumab biosimilar CT-P6

References

• Molina MA, Codony-Servat J, Albanell J, et al. Trastuzumab (herceptin), a humanized anti-Her2 receptor monoclonal antibody, inhibits basal and activated Her2 ectodomain cleavage in breast cancer cells. Cancer Res. 2001;61:4744−4749.
   PubMed Web of Science ®Google Scholar
• Dean-Colomb W, Esteva FJ. Her2-positive breast cancer: herceptin and beyond. Eur J Cancer. 2008;44:2806−2812.
   PubMed Web of Science ®Google Scholar
• Loibl S, Gianni L. HER2-positive breast cancer. Lancet. 2017;389:2415−2429.
   PubMed Web of Science ®Google Scholar
• Cho HS, Mason K, Ramyar KX, et al. Structure of the extracellular region of HER2 alone and in complex with the Herceptin Fab. Nature. 2003;421:756−760.
   PubMed Web of Science ®Google Scholar
• Hudis CA. Trastuzumab-mechanism of action and use in clinical practice. N Engl J Med. 2007;357:39−51.
   PubMed Web of Science ®Google Scholar
• Lammers P, Criscitiello C, Curigliano G, et al. Barriers to the use of trastuzumab for HER2+ breast cancer and the potential impact of biosimilars: a physician survey in the United States and emerging markets. Pharmaceuticals (Basel). 2014;7:943−953.
   PubMedGoogle Scholar
• Patel D, Gillis C, Naggar J, et al. The rise of biosimilars: how they got here and where they are going. Metabolism. 2017;75:45−53.
   PubMed Web of Science ®Google Scholar
• Yoo DH. The rise of biosimilars: potential benefits and drawbacks in rheumatoid arthritis. Expert Rev Clin Immunol. 2014;10:981−983.
   PubMed Web of Science ®Google Scholar
• Gautam A. Market watch: strategies for biosimilars in emerging markets. Nat Rev Drug Discov. 2017;16:520−521.
   PubMed Web of Science ®Google Scholar
• Udpa N, Million RP. Monoclonal antibody biosimilars. Nat Rev Drug Discov. 2016;15:13−14.
   PubMed Web of Science ®Google Scholar
• Belsey MJ, Harris LM, Das RR, et al. Biosimilars: initial excitement gives way to reality. Nat Rev Drug Discov. 2006;5:535−536.
   PubMed Web of Science ®Google Scholar
• Esteva FJ, Stebbing J, Wood-Horrall RN, et al. A randomised trial comparing the pharmacokinetics and safety of the biosimilar CT-P6 with reference trastuzumab. Cancer Chemother Pharmacol. 2018;81:505−514.
   PubMed Web of Science ®Google Scholar
• Stebbing J, Baranau Y, Baryash V, et al. CT-P6 compared with reference trastuzumab for HER2-positive breast cancer: a randomised, double-blind, active-controlled, phase 3 equivalence trial. Lancet Oncol. 2017;18:917−928.
   PubMed Web of Science ®Google Scholar
• Celltrion. Press release. Celltrion receives EU approval for trastuzumab biosimilar. Incheon, Republic of Korea: Celltrion, Inc; 2018.
   Google Scholar
• Ministry of Food and Drug Safety (Republic of Korea). Public assessment summary information for biosimilar. IPRF Biosimilars WG. Herzuma. In Forum IPR (ed); 2015.
   Google Scholar
• Lee J, Kang HA, Bae JS, et al. Evaluation of analytical similarity between trastuzumab biosimilar CT-P6 and reference product using statistical analyses. MAbs. 2018;10(4):547−571.
   Web of Science ®Google Scholar
• Iqbal N, Iqbal N. Human epidermal growth factor receptor 2 (HER2) in cancers: overexpression and therapeutic implications. Mol Biol Int. 2014;2014:852748.
   PubMedGoogle Scholar
• Menard S, Pupa SM, Campiglio M, et al. Biologic and therapeutic role of HER2 in cancer. Oncogene. 2003;22:6570−6578.
   PubMed Web of Science ®Google Scholar
• Olayioye MA. Update on HER-2 as a target for cancer therapy: intracellular signaling pathways of ErbB2/HER-2 and family members. Breast Cancer Res. 2001;3:385−389.
   PubMed Web of Science ®Google Scholar
• Ko BK, Lee SY, Lee YH, et al. Combination of novel HER2-targeting antibody 1E11 with trastuzumab shows synergistic antitumor activity in HER2-positive gastric cancer. Mol Oncol. 2015;9:398−408.
   PubMed Web of Science ®Google Scholar
• Lua WH, Gan SK, Lane DP, et al. A search for synergy in the binding kinetics of Trastuzumab and Pertuzumab whole and F(ab) to Her2. NPJ Breast Cancer. 2015;1:15012.
   PubMed Web of Science ®Google Scholar
• Spector NL, Blackwell KL. Understanding the mechanisms behind trastuzumab therapy for human epidermal growth factor receptor 2-positive breast cancer. J Clin Oncol. 2009;27:5838−5847.
   PubMed Web of Science ®Google Scholar
• Valabrega G, Montemurro F, Sarotto I, et al. TGFalpha expression impairs Trastuzumab-induced HER2 downregulation. Oncogene. 2005;24:3002−3010.
   PubMed Web of Science ®Google Scholar
• Cuello M, Ettenberg SA, Clark AS, et al. Down-regulation of the erbB-2 receptor by trastuzumab (herceptin) enhances tumor necrosis factor-related apoptosis-inducing ligand-mediated apoptosis in breast and ovarian cancer cell lines that overexpress erbB-2. Cancer Res. 2001;61:4892−4900.
   PubMed Web of Science ®Google Scholar
• Klapper LN, Waterman H, Sela M, et al. Tumor-inhibitory antibodies to HER-2/ErbB-2 may act by recruiting c-Cbl and enhancing ubiquitination of HER-2. Cancer Res. 2000;60:3384−3388.
   PubMed Web of Science ®Google Scholar
• Pastuskovas CV, Mundo EE, Williams SP, et al. Effects of anti-VEGF on pharmacokinetics, biodistribution, and tumor penetration of trastuzumab in a preclinical breast cancer model. Mol Cancer Ther. 2012;11:752−762.
   PubMed Web of Science ®Google Scholar
• Wen XF, Yang G, Mao W, et al. HER2 signaling modulates the equilibrium between pro- and antiangiogenic factors via distinct pathways: implications for HER2-targeted antibody therapy. Oncogene. 2006;25:6986−6996.
   PubMed Web of Science ®Google Scholar
• Le XF, Mao W, Lu C, et al. Specific blockade of VEGF and HER2 pathways results in greater growth inhibition of breast cancer xenografts that overexpress HER2. Cell Cycle. 2008;7:3747−3758.
   PubMed Web of Science ®Google Scholar
• Ferrara N, Gerber HP, LeCouter J. The biology of VEGF and its receptors. Nat Med. 2003;9:669−676.
   PubMed Web of Science ®Google Scholar
• Longva KE, Pedersen NM, Haslekas C, et al. Herceptin-induced inhibition of ErbB2 signaling involves reduced phosphorylation of Akt but not endocytic down-regulation of ErbB2. Int J Cancer. 2005;116:359−367.
   PubMed Web of Science ®Google Scholar
• Holbro T, Civenni G, Hynes NE. The ErbB receptors and their role in cancer progression. Exp Cell Res. 2003;284:99−110.
   PubMed Web of Science ®Google Scholar
• Basso AD, Solit DB, Munster PN, et al. Ansamycin antibiotics inhibit Akt activation and cyclin D expression in breast cancer cells that overexpress HER2. Oncogene. 2002;21:1159−1166.
   PubMed Web of Science ®Google Scholar
• Lane HA, Beuvink I, Motoyama AB, et al. ErbB2 potentiates breast tumor proliferation through modulation of p27(Kip1)-Cdk2 complex formation: receptor overexpression does not determine growth dependency. Mol Cell Biol. 2000;20:3210−3223.
   PubMed Web of Science ®Google Scholar
• Neve RM, Sutterluty H, Pullen N, et al. Effects of oncogenic ErbB2 on G1 cell cycle regulators in breast tumour cells. Oncogene. 2000;19:1647−1656.
   PubMed Web of Science ®Google Scholar
• Yakes FM, Chinratanalab W, Ritter CA, et al. Herceptin-induced inhibition of phosphatidylinositol-3 kinase and Akt is required for antibody-mediated effects on p27, cyclin D1, and antitumor action. Cancer Res. 2002;62:4132−4141.
   PubMed Web of Science ®Google Scholar
• Marches R, Uhr JW. Enhancement of the p27Kip1-mediated antiproliferative effect of trastuzumab (Herceptin) on HER2-overexpressing tumor cells. Int J Cancer. 2004;112:492−501.
   PubMed Web of Science ®Google Scholar
• Petricevic B, Laengle J, Singer J, et al. Trastuzumab mediates antibody-dependent cell-mediated cytotoxicity and phagocytosis to the same extent in both adjuvant and metastatic HER2/neu breast cancer patients. J Transl Med. 2013;11:307.
   PubMed Web of Science ®Google Scholar
• Gul N, Babes L, Siegmund K, et al. Macrophages eliminate circulating tumor cells after monoclonal antibody therapy. J Clin Invest. 2014;124:812−823.
   PubMed Web of Science ®Google Scholar
• Suzuki M, Yamanoi A, Machino Y, et al. Effect of trastuzumab interchain disulfide bond cleavage on Fcgamma receptor binding and antibody-dependent tumour cell phagocytosis. J Biochem. 2016;159:67−76.
   PubMed Web of Science ®Google Scholar
• Lazar GA, Dang W, Karki S, et al. Engineered antibody Fc variants with enhanced effector function. Proc Natl Acad Sci U S A. 2006;103:4005−4010.
   PubMed Web of Science ®Google Scholar
• Karagiannis P, Singer J, Hunt J, et al. Characterisation of an engineered trastuzumab IgE antibody and effector cell mechanisms targeting HER2/neu-positive tumour cells. Cancer Immunol Immunother. 2009;58:915−930.
   PubMed Web of Science ®Google Scholar
• Peng Z, Zou J, Zhang X, et al. HER2 discordance between paired primary gastric cancer and metastasis: a meta-analysis. Chin J Cancer Res. 2015;27:163−171.
   PubMed Web of Science ®Google Scholar
• Choi Y, Ko YS, Park J, et al. HER2-induced metastasis is mediated by AKT/JNK/EMT signaling pathway in gastric cancer. World J Gastroenterol. 2016;22:9141−9153.
   PubMed Web of Science ®Google Scholar
• Gravalos C, Jimeno A. HER2 in gastric cancer: a new prognostic factor and a novel therapeutic target. Ann Oncol. 2008;19:1523−1529.
   PubMed Web of Science ®Google Scholar
• Cho JH, Lim JY, Cho JY. Survival analysis based on human epidermal growth factor 2 status in stage II-III gastric cancer. World J Gastroenterol. 2017;23:7407−7414.
   PubMed Web of Science ®Google Scholar
• Ko YS, Cho SJ, Park J, et al. Loss of FOXO1 promotes gastric tumour growth and metastasis through upregulation of human epidermal growth factor receptor 2/neu expression. Br J Cancer. 2015;113:1186−1196.
   PubMed Web of Science ®Google Scholar
• Sliwkowski MX, Lofgren JA, Lewis GD, et al. Nonclinical studies addressing the mechanism of action of trastuzumab (Herceptin). Semin Oncol. 1999;26:60−70.
   PubMed Web of Science ®Google Scholar
• Fujimoto-Ouchi K, Sekiguchi F, Yasuno H, et al. Antitumor activity of trastuzumab in combination with chemotherapy in human gastric cancer xenograft models. Cancer Chemother Pharmacol. 2007;59:795−805.
   PubMed Web of Science ®Google Scholar
• Matsui Y, Inomata M, Tojigamori M, et al. Suppression of tumor growth in human gastric cancer with HER2 overexpression by an anti-HER2 antibody in a murine model. Int J Oncol. 2005;27:681−685.
   PubMed Web of Science ®Google Scholar
• Tanner M, Hollmen M, Junttila TT, et al. Amplification of HER-2 in gastric carcinoma: association with topoisomerase IIalpha gene amplification, intestinal type, poor prognosis and sensitivity to trastuzumab. Ann Oncol. 2005;16:273−278.
   PubMed Web of Science ®Google Scholar
• Kono K, Takahashi A, Ichihara F, et al. Impaired antibody-dependent cellular cytotoxicity mediated by herceptin in patients with gastric cancer. Cancer Res. 2002;62:5813−5817.
   PubMed Web of Science ®Google Scholar
• Collins DM, O’Donovan N, McGowan PM, et al. Trastuzumab induces antibody-dependent cell-mediated cytotoxicity (ADCC) in HER-2-non-amplified breast cancer cell lines. Ann Oncol. 2012;23:1788−1795.
   PubMed Web of Science ®Google Scholar
• Mimura K, Kono K, Hanawa M, et al. Trastuzumab-mediated antibody-dependent cellular cytotoxicity against esophageal squamous cell carcinoma. Clin Cancer Res. 2005;11:4898−4904.
   PubMed Web of Science ®Google Scholar
• Collins I, Francis P, Mileshkin L. Adjuvant trastuzumab in HER2-positive breast cancer. N Engl J Med. 2012;366:664−666. author reply.
   PubMedGoogle Scholar
• Albanell J, Codony J, Rovira A, et al. Mechanism of action of anti-HER2 monoclonal antibodies: scientific update on trastuzumab and 2C4. Adv Exp Med Biol. 2003;532:253−268.
   PubMed Web of Science ®Google Scholar
• Junttila TT, Akita RW, Parsons K, et al. Ligand-independent HER2/HER3/PI3K complex is disrupted by trastuzumab and is effectively inhibited by the PI3K inhibitor GDC-0941. Cancer Cell. 2009;15:429−440.
   PubMed Web of Science ®Google Scholar
• Sendur MA, Aksoy S, Zengin N. Pertuzumab plus trastuzumab in metastatic breast cancer. N Engl J Med. 2012;366:1348. author reply 1349−1350.
   PubMedGoogle Scholar
• von Minckwitz G, Procter M, de Azambuja E, et al. Adjuvant pertuzumab and trastuzumab in early HER2-positive breast cancer. N Engl J Med. 2017;377:122−131.
   PubMed Web of Science ®Google Scholar