Publication Cover
Xenobiotica
the fate of foreign compounds in biological systems
Volume 49, 2019 - Issue 9
3,176
Views
60
CrossRef citations to date
0
Altmetric
Animal Pharmacokinetics and Metabolism

Comprehensive preclinical pharmacokinetic evaluations of trastuzumab deruxtecan (DS-8201a), a HER2-targeting antibody-drug conjugate, in cynomolgus monkeys

, , &
Pages 1086-1096 | Received 03 Aug 2018, Accepted 28 Sep 2018, Published online: 04 Jan 2019

References

  • Castaigne S, Pautas C, Terré C, et al. (2012). Effect of gemtuzumab ozogamicin on survival of adult patients with de-novo acute myeloid leukaemia (ALFA-0701): a randomised, open-label, phase 3 study. Lancet 379:1508–16.
  • Charasson V, Haaz MC, Robert J. (2002). Determination of drug interactions occurring with the metabolic pathways of irinotecan. Drug Metab Dispos 30:731–3.
  • Dan N, Setu AS, Kashyap VK, et al. (2018). Antibody-drug conjugates for cancer therapy: chemistry to clinical implications. Pharmaceuticals 11:32.
  • Davies B, Morris T. (1993). Physiological parameters in laboratory animals and humans. Pharm Res 10:1093–5.
  • Doi T, Shitara K, Naito Y, et al. (2017). 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 18:1512–22.
  • Durmus S, van Hoppe S, Schinkel AH. (2016). The impact of organic anion-transporting polypeptides (OATPs) on disposition and toxicity of antitumor drugs: insights from knockout and humanized mice. Drug Resist Updat 27:72–88.
  • Gutierrez C, Schiff R. (2011). HER2: biology, detection, and clinical implications. Arch Pathol Lab Med 135:55–62.
  • Hamblett KJ, Senter PD, Chace DF, et al. (2004). Effects of drug loading on the antitumor activity of a monoclonal antibody drug conjugate effects of drug loading on the antitumor activity of a monoclonal antibody drug conjugate. Clin Cancer Res 10:7063–70.
  • Inoue K, Sonobe M, Kawamura Y, et al. (2013). Polymorphisms of the UDP-glucuronosyl transferase 1A genes are associated with adverse events in cancer patients receiving irinotecan-based chemotherapy. Tohoku J Exp Med 229:107–14.
  • Iwata H, Tamura K, Doi T, et al. (2018). Trastuzumab deruxtecan (DS-8201a) in subjects with HER2-expressing solid tumors: Long-term results of a large phase 1 study with multiple expansion cohorts. J Clin Oncol 36:2501.
  • Kantarjian HM, Su Y, Jabbour EJ, et al. (2018). Patient-reported outcomes from a phase 3 randomized controlled trial of inotuzumab ozogamicin versus standard therapy for relapsed/refractory acute lymphoblastic leukemia. Cancer 124:2151–60.
  • 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.
  • Krop IE, Kim SB, González-Martín A, et al. (2014). Trastuzumab emtansine versus treatment of physician’s choice for pretreated HER2-positive advanced breast cancer (TH3RESA): a randomised, open-label, phase 3 trial. Lancet Oncol 15:689–99.
  • Lambert JM, Berkenblit A. (2018). Antibody-drug conjugates for cancer treatment. Annu Rev Med 69:191–207.
  • Lampe J, Bigler J, Horner N, et al. (1999). UDP-glucuronosyltransferase (UGT1A1*28 and UGT1A6*2) polymorphisms in Caucasians and Asians: relationships to serum bilirubin concentrations. Pharmacogenetics, 9:341–9.
  • Li X, Xu SN, Qin DB, et al. (2014). Effect of adding gemtuzumab ozogamicin to induction chemotherapy for newly diagnosed acute myeloid leukemia: a meta-analysis of prospective randomized phase III trials. Ann Oncol 25:455–61.
  • Malik P, Phipps C, Edginton A, et al. (2017). Pharmacokinetic considerations for antibody-drug conjugates against cancer. Pharm Res 34:2579–95.
  • Nakada T, Masuda T, Naito H, et al. (2016). Novel antibody-drug conjugates containing exatecan derivative-based cytotoxic payloads. Bioorganic Med Chem Lett 26:1542–5.
  • Nozawa T, Minami T, Sugiura S, et al. (2005). Role of organic anion transporter OATP1B1 (OATP-C) in hepatic uptake of irinotecan and its active metabolite, 7-ethyl-10-hydroxycamptothecin: in vitro evidence and effect of single nucleotide polymorphisms. Drug Metab Dispos 33:434–9.
  • 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 107:1039–46.
  • Peters C, Brown S. (2015). Antibody-drug conjugates as novel anti-cancer chemotherapeutics. Biosci Rep 35:e00225.
  • Prince HM, Kim YH, Horwitz S, et al. (2017). Brentuximab vedotin or physician’s choice in CD30-positive cutaneous T-cell lymphoma (ALCANZA): an international, open-label, randomised, phase 3, multicentre trial. Lancet 390:555–66.
  • Sau S, Alsaab HO, Kashaw SK, et al. (2017). Advances in antibody-drug conjugates: a new era of targeted cancer therapy. Drug Discov Today 22:1547–56.
  • Sun X, Ponte FJ, Yoder CN, et al. (2017). Effects of drug-antibody ratio on pharmacokinetics, biodistribution, efficacy, and tolerability of antibody-maytansinoid conjugates. Bioconjugate Chem 28:1371–81.
  • Trastuzumab (Herceptin®) BLA. (2018). Available at the website of PMDA: http://www.pmda.go.jp/drugs/2001/P200100003/index.html [Accessed 23 July 2018].
  • Trastuzumab emtansine (Herceptin®) BLA. (2018). Available at the website of PMDA: http://www.pmda.go.jp/drugs/2013/P201300137/index.html [Accessed 23 July 2018]
  • Yamada M, Takei M, Suzuki E, et al. (2017). Pharmacokinetics, distribution, and disposition of esaxerenone, a novel, highly potent and selective non-steroidal mineralocorticoid receptor antagonist, in rats and monkeys. Xenobiotica 47:1090–103.
  • Yu L, Yao Y, Wang Y, et al. (2018). Preparation and anti-cancer evaluation of promiximab-MMAE, an anti-CD56 antibody-drug conjugate, in small cell lung cancer cell line xenograft models. J Drug Target 13:1–8.
  • Zhou Q. (2018). Site-specific antibody conjugation for ADC and beyond. Biomedicines 5:64.

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.