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Xenobiotica
the fate of foreign compounds in biological systems
Volume 50, 2020 - Issue 10
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Animal Pharmacokinetics and Metabolism

Pharmacokinetics of trastuzumab deruxtecan (T-DXd), a novel anti-HER2 antibody-drug conjugate, in HER2-positive tumour-bearing mice

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Pages 1242-1250 | Received 27 Feb 2020, Accepted 11 Apr 2020, Published online: 22 Apr 2020

References

  • Amiri-Kordestani L, Blumenthal GM, Xu QC, et al. (2014). FDA approval: ado-trastuzumab emtansine for the treatment of patients with HER2-positive metastatic breast cancer. Clin Cancer Res 20:4436–41.
  • Beck A, Goetsch L, Dumontet C, Corvaïa N. (2017). Strategies and challenges for the next generation of antibody-drug conjugates. Nat Rev Drug Discov 16:315–37.
  • Beck A, Reichert JM. (2014). Antibody-drug conjugates present and future. MAbs 6:15–7.
  • Click ZR, Seddon AN, Bae YR, et al. (2018). New food and drug administration–approved and emerging novel treatment options for acute myeloid leukemia. Pharmacotherapy 38:1143–54.
  • Davies B, Morris T. (1993). Physiological parameters in laboratory animals and humans. Pharm Res 10:1093–5.
  • De Claro RA, McGinn K, Kwitkowski V, et al. (2012). U.S. Food and Drug Administration approval summary: brentuximab vedotin for the treatment of relapsed Hodgkin lymphoma or relapsed systemic anaplastic large-cell lymphoma. Clin Cancer Res 18:5845–9.
  • Doi T, Iwata H, Tsurutani J, et al. (2017a). Single agent activity of DS-8201a, a HER2-targeting antibody-drug conjugate, in heavily pretreated HER2 expressing solid tumors. J Clin Oncol 35:108.
  • Doi T, Shitara K, Naito Y, et al. (2017b). Safety, pharmacokinetics, and antitumour activity of trastuzumab deruxtecan (DS-8201), a HER2-targeting antibody-drug conjugate, in patients with advanced breast and gastric or gastro-oesophageal tumours: a phase 1 dose-escalation study. Lancet Oncol 18:1512–1522.
  • Hamblett KJ, Senter PD, Chace DF, et al. (2004). Effects of drug loading on the antitumor activity of a monoclonal antibody drug conjugate. Clin Cancer Res 10:7063–70.
  • Iwata TN, Ishii C, Ishida S, et al. (2018). A HER2-targeting antibody–drug conjugate, trastuzumab deruxtecan (DS-8201a), enhances antitumor immunity in a mouse model. Mol Cancer Ther 17:1494–503.
  • Iyer L, King CD, Whitington PF, et al. (1998). Genetic predisposition to the metabolism of irinotecan (CPT-11): role of uridine diphosphate glucuronosyltransferase isoform 1A1 in the glucuronidation of its active metabolite (SN-38) in human liver microsomes. J Clin Invest 101:847–54.
  • Jinno H, Tanaka-Kagawa T, Hanioka N, et al. (2003). Glucuronidation of 7-ethyl-10-hydroxycamptothecin (SN-38), an active metabolite of irinotecan (CPT-11), by human UGT1A1 variants, G71R, P229Q, and Y486D. Drug Metab Dispos 31:108–13.
  • Kantarjian HM, DeAngelo DJ, Stelljes M, et al. (2019). Inotuzumab ozogamicin versus standard of care in relapsed or refractory acute lymphoblastic leukemia: final report and long-term survival follow-up from the randomized, phase 3 INO-VATE study. Cancer 125:2474–87.
  • Kaplon H, Muralidharan M, Schneider Z, Reichert JM. (2020). Antibodies to watch in 2020. MAbs 12:1703531.e1703531-1–24.
  • Krop IE, Beeram M, Modi S, et al. (2010). Phase I study of trastuzumab-DM1, an HER2 antibody-drug conjugate, given every 3 weeks to patients with HER2-positive metastatic breast cancer. J Clin Oncol 28:2698–704.
  • LoRusso PM, Weiss D, Guardino E, et al. (2011). Trastuzumab emtansine: a unique antibody-drug conjugate in development for human epidermal growth factor receptor 2-positive cancer. Clin Cancer Res 17:6437–47.
  • Maeda H. (2001). The enhanced permeability and retention (EPR) effect in tumor vasculature: the key role of tumor-selective macromolecular drug targeting. Adv Enzyme Regul 41:189–207.
  • Malik P, Phipps C, Edginton A, Blay J. (2017). Pharmacokinetic considerations for antibody-drug conjugates against cancer. Pharm Res 34:2579–95.
  • Nagai Y, Oitate M, Shiozawa H, Ando O. (2019). Comprehensive preclinical pharmacokinetic evaluations of trastuzumab deruxtecan conjugate, in cynomolgus monkeys. Xenobiotica 49:1086–96.
  • Nakada T, Masuda T, Naito H, et al. (2016). Novel antibody drug conjugates containing exatecan derivative-based cytotoxic payloads. Bioorganic Med Chem Lett 26:1542–45.
  • Ogitani Y, Aida T, Hagihara K, et al. (2016a). DS-8201a, a novel HER2-targeting ADC with a novel DNA topoisomerase I inhibitor, demonstrates a promising antitumor efficacy with differentiation from T-DM1. Clin Cancer Res 22:5097–108.
  • Ogitani Y, Hagihara K, Oitate M, et al. (2016b). Bystander killing effect of DS-8201a, a novel anti-human epidermal growth factor receptor 2 antibody-drug conjugate, in tumors with human epidermal growth factor receptor 2 heterogeneity. Cancer Sci 107:1039–1046.
  • Sai K, Sawada JI, Minami H. (2008). Irinotecan pharmacogenetics in Japanese cancer patients: roles of UGT1A1*6 and *28. Yakugaku Zasshi 128:575–84.
  • Shiose Y, Ochi Y, Kuga H, et al. (2007). Relationship between drug release of DE-310, macromolecular prodrug of DX-8951f, and cathepsins activity in several tumors. Biol Pharm Bull 30:2365–70.
  • Takegawa N, Nonagase Y, Yonesaka K, et al. (2017). DS-8201a, a new HER2-targeting antibody–drug conjugate incorporating a novel DNA topoisomerase I inhibitor, overcomes HER2-positive gastric cancer T-DM1 resistance. Int J Cancer 141:1682–9.
  • Trastuzumab emtansine (Kadcyla) BLA. 2013. Available from: http://www.pmda.go.jp/drugs/2013/P201300137/index.html [last accessed 24 Apr 2019].

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