4,180
Views
47
CrossRef citations to date
0
Altmetric
Review

Comparative clinical pharmacokinetics of antibody-drug conjugates in first-in-human Phase 1 studies

Pages 859-870 | Received 21 Feb 2014, Accepted 22 Apr 2014, Published online: 25 Apr 2014

References

  • Gorovits B, Alley SC, Bilic S, Booth B, Kaur S, Oldfield P, Purushothama S, Rao C, Shord S, Siguenza P. Bioanalysis of antibody-drug conjugates: American Association of Pharmaceutical Scientists Antibody-Drug Conjugate Working Group position paper. Bioanalysis 2013; 5:997 - 1006; http://dx.doi.org/10.4155/bio.13.38; PMID: 23641692
  • Mullard A. Maturing antibody-drug conjugate pipeline hits 30. Nat Rev Drug Discov 2013; 12:329 - 32; http://dx.doi.org/10.1038/nrd4009; PMID: 23629491
  • Lapusan S, Vidriales MB, Thomas X, de Botton S, Vekhoff A, Tang R, Dumontet C, Morariu-Zamfir R, Lambert JM, Ozoux ML, et al. Phase I studies of AVE9633, an anti-CD33 antibody-maytansinoid conjugate, in adult patients with relapsed/refractory acute myeloid leukemia. Invest New Drugs 2012; 30:1121 - 31; http://dx.doi.org/10.1007/s10637-011-9670-0; PMID: 21519855
  • Rowe JM, Löwenberg B. Gemtuzumab ozogamicin in acute myeloid leukemia: a remarkable saga about an active drug. Blood 2013; 121:4838 - 41; http://dx.doi.org/10.1182/blood-2013-03-490482; PMID: 23591788
  • Lu D, Joshi A, Wang B, Olsen S, Yi JH, Krop IE, Burris HA, Girish S. An integrated multiple-analyte pharmacokinetic model to characterize trastuzumab emtansine (T-DM1) clearance pathways and to evaluate reduced pharmacokinetic sampling in patients with HER2-positive metastatic breast cancer. Clin Pharmacokinet 2013; 52:657 - 72; http://dx.doi.org/10.1007/s40262-013-0060-y; PMID: 23553425
  • Pascual MH, Verdier P, Malette P, Mnich J, Ozoux ML. Validation of an immunoassay to selectively quantify the naked antibody of a new Antibody Drug Conjugate--SAR566658--for pharmacokinetic interpretation improvement. J Immunol Methods 2013; 396:140 - 6; http://dx.doi.org/10.1016/j.jim.2013.06.012; PMID: 23892158
  • Dirks NL, Meibohm B. Population pharmacokinetics of therapeutic monoclonal antibodies. Clin Pharmacokinet 2010; 49:633 - 59; http://dx.doi.org/10.2165/11535960-000000000-00000; PMID: 20818831
  • Lobo ED, Hansen RJ, Balthasar JP. Antibody pharmacokinetics and pharmacodynamics. J Pharm Sci 2004; 93:2645 - 68; http://dx.doi.org/10.1002/jps.20178; PMID: 15389672
  • EMA [Internet] Refusal assessment report for Mylotarg, Procedure No. EMEA/H/C/000705 2008 [Cited 2014 Feb 20] Available from http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/000705/WC500070677.pdf
  • Keizer RJ, Huitema AD, Schellens JH, Beijnen JH. Clinical pharmacokinetics of therapeutic monoclonal antibodies. Clin Pharmacokinet 2010; 49:493 - 507; http://dx.doi.org/10.2165/11531280-000000000-00000; PMID: 20608753
  • Drugs@FDA:Kadcyla [Internet] Application Number: 125427orig1s000, Clinical Pharmacology and Biopharmaceutics Reviews [Cited 2014 Feb 20] Available from http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/125427Orig1s000ClinPharmR.pdf
  • Bruno R, Washington CB, Lu JF, Lieberman G, Banken L, Klein P. Population pharmacokinetics of trastuzumab in patients with HER2+ metastatic breast cancer. Cancer Chemother Pharmacol 2005; 56:361 - 9; http://dx.doi.org/10.1007/s00280-005-1026-z; PMID: 15868146
  • Tabrizi MA, Tseng CM, Roskos LK. Elimination mechanisms of therapeutic monoclonal antibodies. Drug Discov Today 2006; 11:81 - 8; http://dx.doi.org/10.1016/S1359-6446(05)03638-X; PMID: 16478695
  • Dowell JA, Korth-Bradley J, Liu H, King SP, Berger MS. Pharmacokinetics of gemtuzumab ozogamicin, an antibody-targeted chemotherapy agent for the treatment of patients with acute myeloid leukemia in first relapse. J Clin Pharmacol 2001; 41:1206 - 14; http://dx.doi.org/10.1177/00912700122012751; PMID: 11697753
  • Drugs@FDA:Adcetris [Internet] Application Number: 125388Orig1s000, Clinical Pharmacology and Biopharmaceutics Reviews [Cited 2014 Feb 20] Available from http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/125388Orig1s000ClinPharmR.pdf
  • Girish S, Gupta M, Wang B, Lu D, Krop IE, Vogel CL, Burris Iii HA, LoRusso PM, Yi JH, Saad O, et al. Clinical pharmacology of trastuzumab emtansine (T-DM1): an antibody-drug conjugate in development for the treatment of HER2-positive cancer. Cancer Chemother Pharmacol 2012; 69:1229 - 40; http://dx.doi.org/10.1007/s00280-011-1817-3; PMID: 22271209
  • Ferte C, Soria JC, Penel N. Dose-levels and first signs of efficacy in contemporary oncology Phase 1 clinical trials. PLoS One 2011; 6:e16633; http://dx.doi.org/10.1371/journal.pone.0016633; PMID: 21415927
  • Roberts SA, Andrews PA, Blanset D, Flagella KM, Gorovits B, Lynch CM, Martin PL, Kramer-Stickland K, Thibault S, Warner G. Considerations for the nonclinical safety evaluation of antibody drug conjugates for oncology. Regul Toxicol Pharmacol 2013; 67:382 - 91; http://dx.doi.org/10.1016/j.yrtph.2013.08.017; PMID: 24012707
  • Annunziata CM, Kohn EC, LoRusso P, Houston ND, Coleman RL, Buzoianu M, Robbie G, Lechleider R. Phase 1, open-label study of MEDI-547 in patients with relapsed or refractory solid tumors. Invest New Drugs 2013; 31:77 - 84; http://dx.doi.org/10.1007/s10637-012-9801-2; PMID: 22370972
  • Haddish-Berhane N, Shah DK, Ma D, Leal M, Gerber HP, Sapra P, Barton HA, Betts AM. On translation of antibody drug conjugates efficacy from mouse experimental tumors to the clinic: a PK/PD approach. J Pharmacokinet Pharmacodyn 2013; 40:557 - 71; http://dx.doi.org/10.1007/s10928-013-9329-x; PMID: 23933716
  • Coiffier B, Morschhauser F, Dupuis J, Haioun C, Laine F, Houot R, et al. Phase I study cohort evaluating an optimized administration schedule of SAR3419, an anti-CD19 DM4-loaded antibody drug conjugate (ADC), in patients (pts) with CD19 positive relapsed/refractory b-cell non-Hodgkin's lymphoma. J Clin Oncol 2012; 30:Suppl. 1 8057
  • Castaigne S, Pautas C, Terré C, Raffoux E, Bordessoule D, Bastie JN, Legrand O, Thomas X, Turlure P, Reman O, et al, Acute Leukemia French Association. 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 2012; 379:1508 - 16; http://dx.doi.org/10.1016/S0140-6736(12)60485-1; PMID: 22482940
  • Sapra P, Betts A, Boni J. Preclinical and clinical pharmacokinetic/pharmacodynamic considerations for antibody-drug conjugates. Expert Rev Clin Pharmacol 2013; 6:541 - 55; http://dx.doi.org/10.1586/17512433.2013.827405; PMID: 23978126
  • Food and Drug Administration Guidance for Industry: Estimating the Maximum Safe Starting Dose in Initial Clinical Trials for Therapeutics in Adult Healthy Volunteers, U.S. Department of Health and Human Services,, Center for Drug Evaluation and Research (CDER), July 2005
  • Advani A, Coiffier B, Czuczman MS, Dreyling M, Foran J, Gine E, Gisselbrecht C, Ketterer N, Nasta S, Rohatiner A, et al. Safety, pharmacokinetics, and preliminary clinical activity of inotuzumab ozogamicin, a novel immunoconjugate for the treatment of B-cell non-Hodgkin’s lymphoma: results of a phase I study. J Clin Oncol 2010; 28:2085 - 93; http://dx.doi.org/10.1200/JCO.2009.25.1900; PMID: 20308665
  • Chanan-Khan A, Wolf JL, Garcia J, Gharibo M, Jagannath S, Manfredi D, et al. Efficacy analysis from phase I study of lorvotuzumab mertansine (IMGN901), used as monotherapy, in patients with heavily pre-treated CD56-positive multiple myeloma - A preliminary efficacy analysis. Blood 2010; 116:21
  • Chanan-Khan AA, Jagannath S, Heffner LT, Avigan D, Lee KP, Lutz RJ, et al. Phase I study of BT062 given as repeated single dose once every 3 weeks in patients with relapsed or relapsed/refractory multiple myeloma. Blood 2009; 114:22
  • Galsky MD, Eisenberger M, Moore-Cooper S, Kelly WK, Slovin SF, DeLaCruz A, Lee Y, Webb IJ, Scher HI. Phase I trial of the prostate-specific membrane antigen-directed immunoconjugate MLN2704 in patients with progressive metastatic castration-resistant prostate cancer. J Clin Oncol 2008; 26:2147 - 54; http://dx.doi.org/10.1200/JCO.2007.15.0532; PMID: 18362364
  • Krop IE, Beeram M, Modi S, Jones SF, Holden SN, Yu W, Girish S, Tibbitts J, Yi JH, Sliwkowski MX, et al. 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 2010; 28:2698 - 704; http://dx.doi.org/10.1200/JCO.2009.26.2071; PMID: 20421541
  • Petrylak DP, Kantoff PW, Mega AE, Vogelzang NJ, Stephenson J, Fleming MT, Stambler N, Petrini M, Blattman S, Israel RJ. Prostate- specific membrane antigen antibody drug conjugate (PSMA ADC): A phase I trial in metastatic castration-resistant prostate cancer (mCRPC) previously treated with a taxane. J Clin Oncol 2013; 31 Suppl. 1
  • Sauter A, Kloft C, Gronau S, Bogeschdorfer F, Erhardt T, Golze W, Schroen C, Staab A, Riechelmann H, Hoermann K. Pharmacokinetics, immunogenicity and safety of bivatuzumab mertansine, a novel CD44v6-targeting immunoconjugate, in patients with squamous cell carcinoma of the head and neck. Int J Oncol 2007; 30:927 - 35; PMID: 17332932

  • Tolcher AW, Ochoa L, Hammond LA, Patnaik A, Edwards T, Takimoto C, Smith L, de Bono J, Schwartz G, Mays T, et al. Cantuzumab mertansine, a maytansinoid immunoconjugate directed to the CanAg antigen: a phase I, pharmacokinetic, and biologic correlative study. J Clin Oncol 2003; 21:211 - 22; http://dx.doi.org/10.1200/JCO.2003.05.137; PMID: 12525512
  • Younes A, Kim S, Romaguera J, Copeland A, Farial SdeC, Kwak LW, Fayad L, Hagemeister F, Fanale M, Neelapu S, et al. Phase I multidose-escalation study of the anti-CD19 maytansinoid immunoconjugate SAR3419 administered by intravenous infusion every 3 weeks to patients with relapsed/refractory B-cell lymphoma. J Clin Oncol 2012; 30:2776 - 82; http://dx.doi.org/10.1200/JCO.2011.39.4403; PMID: 22753910

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.