On translation of antibody drug conjugates efficacy from mouse experimental tumors to the clinic: A PK/PD approach

Journal of Pharmacokinetics and Pharmacodynamics

Volumn 40, Issue 5, 2013, Pages 557-571

  Haddish Berhane, Nahor ^a   Shah, Dhaval K ^a   Ma, Dangshe ^a   Leal, Mauricio ^a   Gerber, Hans Peter ^a   Sapra, Puja ^a   Barton, Hugh A ^a   Betts, Alison M ^a  

^a PFIZER INC   (United States)

Author keywords

Antibody drug conjugates; Pharmacodynamics; Pharmacokinetics; Prediction; Translation; Tumor regression; Xenograft

Indexed keywords

ANTIBODY CONJUGATE; TRASTUZUMAB; TRASTUZUMAB EMTANSINE;

ANIMAL CELL; ANIMAL EXPERIMENT; ANIMAL MODEL; ARTICLE; BREAST CANCER; CANCER INHIBITION; CLINICAL EFFECTIVENESS; CONCENTRATION (PARAMETERS); CONTROLLED STUDY; DRUG EFFICACY; DRUG SCREENING; FEMALE; HAPLORHINI; HUMAN; LUNG NON SMALL CELL CANCER; MOUSE; NONBIOLOGICAL MODEL; NONHUMAN; PHARMACODYNAMICS; PHARMACODYNAMICS PHARMACOKINETICS MODEL; PRIORITY JOURNAL; TUMOR STATIC CONCENTRATION; TUMOR XENOGRAFT;

ANIMALS; ANTIBODIES; ANTIBODIES, MONOCLONAL, HUMANIZED; ANTINEOPLASTIC AGENTS; CELL LINE, TUMOR; FEMALE; HUMANS; IMMUNOCONJUGATES; MAYTANSINE; MICE; MICE, NUDE; NEOPLASMS, EXPERIMENTAL; XENOGRAFT MODEL ANTITUMOR ASSAYS;

EID: 84885643512     PISSN: 1567567X     EISSN: 15738744     Source Type: Journal    
DOI: 10.1007/s10928-013-9329-x     Document Type: Article

References (36)

1. Ducry L, Stump B (2010) Antibody-drug conjugates: linking cytotoxic payloads to monoclonal antibodies. Bioconjug Chem 21(1):5-13
2. Deng C, Pan B, O'Connor OA (2013) Brentuximab vedotin. Clin Cancer Res 19(1):22-27. doi: 10.1158/1078-0432.ccr-12-0290
3. Burris HA, Rugo HS, Vukelja SJ, Vogel CL, Borson RA, Limentani S, Tan-Chiu E, Krop IE, Michaelson RA, Girish S, Amler L, Zheng M, Chu Y-W, Klencke B, O'Shaughnessy JA (2011) Phase II study of the antibody drug conjugate trastuzumab-DM1 for the treatment of human epidermal growth factor receptor 2 (HER2) positive breast cancer after prior HER2-directed therapy. J Clin Oncol 29(4):398-405. doi: 10.1200/jco.2010.29.5865
4. Fayad L, Patel H, Verhoef G, Smith M, Johnson P, Czuczman M, Coiffier B, Hess G, Gine E, Advani A et al (2008) Safety and clinical activity of the anti-CD22 immunoconjugate inotuzumabozogamicin (CMC-544) in combination with rituximab in follicular lymphoma or diffuse large B-cell lymphoma: preliminary report of a phase 1/2 study. In: Paper presented at the blood: ASH annual meeting abstracts
5. Kantarjian H, Thomas D, Jorgensen J, Jabbour E, Kebriaei P, Rytting M, York S, Ravandi F, Kwari M, Faderl S, Rios MB, Cortes J, Fayad L, Tarnai R, Wang SA, Champlin R, Advani A, O'Brien S (2012) Inotuzumab ozogamicin, an anti-CD22-calecheamicin conjugate, for refractory and relapsed acute lymphocytic leukaemia: a phase 2 study. Lancet Oncol 13(4):403-411
6. Sapra P, Hooper AT, O'Donnell CJ, Gerber H-P (2011) Investigational antibody drug conjugates for solid tumors. Expert Opin Investig Drugs 20(8):1131-1149. doi: 10.1517/13543784.2011.582866
7. Johnson JI, Decker S, Zaharevitz D, Rubinstein LV, Venditti JM, Schepartz S, Kalyandrug S, Christian M, Arbuck S, Hollingshead M, Sausville EA (2001) Relationships between drug activity in NCI preclinical in vitro and in vivo models and early clinical trials. Br J Cancer 84(10):1424-1431
8. Kelland LR (2004) Of mice and men: values and liabilities of the athymic nude mouse model in anticancer drug development. Eur J Cancer 40(6):827-836
9. Kerbel RS (2003) Human tumor xenografts as predictive preclinical models for anticancer drug activity in humans: better than commonly perceived - but they can be improved. Cancer Biol Ther 2:0-5
10. Peterson JK, Houghton PJ (2004) Integrating pharmacology and in vivo cancer models in preclinical and clinical drug development. Eur J Cancer 40(6):837-844. doi: 10.1016/j.ejca.2004.01.003
11. Troiani T, Schettino C, Martinelli E, Morgillo F, Tortora G, Ciardiello F (2008) The use of xenograft models for the selection of cancer treatments with the EGFR as an example. Crit Rev Oncol/Hematol 65(3):200-211. doi: 10.1016/j.critrevonc.2007.10.003
12. Voskoglou-Nomikos T, Pater JL, Seymour L (2003) Clinical predictive value of the in vitro cell Line, human xenograft, and mouse allograft preclinical cancer models. Clin Cancer Res 9(11):4227-4239
13. Jumbe N, Xin Y, Leipold D, Crocker L, Dugger D, Mai E, Sliwkowski M, Fielder P, Tibbitts J (2010) Modeling the efficacy of trastuzumab-DM1, an antibody drug conjugate, in mice. J Pharmacokinet Pharmacodyn 37(3):221-242
14. Mordenti J, Thomsen K, Licko V, Chen H, Gloria Meng Y, Ferrara N (1999) Efficacy and concentration-response of murine anti-VEGF monoclonal antibody in tumor-bearing mice and extrapolation to humans. Toxicol Pathol 27(1):14-21. doi: 10.1177/019262339902700104
15. Rocchetti M, Simeoni M, Pesenti E, De Nicolao G, Poggesi I (2007) Predicting the active doses in humans from animal studies: a novel approach in oncology. Eur J Cancer 43(12):1862-1868
16. Wong H, Choo EF, Alicke B, Ding X, La H, McNamara E, Theil F-P, Tibbitts J, Friedman LS, Hop CECA, Gould SE (2012) Antitumor activity of targeted and cytotoxic agents in murine subcutaneous tumor models correlates with clinical response. Clin Cancer Res 18(14):3846-3855. doi: 10.1158/1078-0432.ccr-12-0738
17. Agoram BM, Martin SW, van der Graaf PH (2007) The role of mechanism-based pharmacokinetic-pharmacodynamic (PK-PD) modelling in translational research of biologics. Drug Discov Today 12(23-24):1018-1024
18. Simeoni M, Magni P, Cammia C, De Nicolao G, Croci V, Pesenti E, Germani M, Poggesi I, Rocchetti M (2004) Predictive pharmacokinetic-pharmacodynamic modeling of tumor growth kinetics in xenograft models after administration of anticancer agents. Cancer Res 64(3):1094-1101. doi: 10.1158/0008-5472.can-03- 2524
19. Lobo ED, Balthasar JP (2002) Pharmacodynamic modeling of chemotherapeutic effects: application of a transit compartment model to characterize methotrexate effects in vitro. AAPS Pharmsci 4(4):1-11
20. Sapra P, DiJoseph J, Damelin M, Dougher M, Narayanan B, Khandke K, Lucas J, Golas J, Tchistiakova L, Leal M, Hu G, Maderna A, Marquette K, Loganzo F, Dushin R, O'Donnell CJ, Abraham R, Gerber H-P (2012) Long-term tumor regression induced by a novel antibody drug conjugate that targets 5T4, an oncofetal antigen expressed on tumor-initiating cells. In: Proceedings of the 103rd annual meeting of the American Association for Cancer Research, Philadelphia, PA. AACR, Chicago, IL, Mar 31-Apr 4, 2012. Cancer Res. p Abstract nr 2530
21. Doronina SO, Mendelsohn BA, Bovee TD, Cerveny CG, Alley SC, Meyer DL, Oflazoglu E, Toki BE, Sanderson RJ, Zabinski RF, Wahl AF, Senter PD (2006) Enhanced activity of monomethylauristatin F through monoclonal antibody delivery: effects of linker technology on efficacy and toxicity. Bioconjug Chem 17(1):114-124
22. Krop IE, Beeram M, Modi S, Jones SF, Holden SN, Yu W, Girish S, Tibbitts J, Yi J-H, Sliwkowski MX, Jacobson F, Lutzker SG, Burris HA (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(16):2698-2704. doi: 10.1200/jco.2009.26.2071
23. Ling J, Zhou H, Jiao Q, Davis HM (2009) Interspecies scaling of therapeutic monoclonal antibodies: initial look. J Clin Pharmacol 49(12):1382-1402. doi: 10.1177/0091270009337134
24. Deng R, Iyer S, Theil F-P, Mortensen DL, Fielder PJ, Prabhu S (2011) Projecting human pharmacokinetics of therapeutic antibodies from nonclinical data: what have we learned? mAbs 3(1):61-66
25. Yang J, Mager D, Straubinger R (2009) Comparison of two pharmacodynamic transduction models for the analysis of tumor therapeutic responses in model systems. AAPS J 12(1):1-10
26. Jacqmin P, McFadyen L, Wade J (2010) Basic PK/PD principles of drug effects in circular/proliferative systems for disease modelling. J Pharmacokinet Pharmacodyn 37(2):157-177
27. Muller PY, Milton M, Lloyd P, Sims J, Brennan FR (2009) The minimum anticipated biological effect level (MABEL) for selection of first human dose in clinical trials with monoclonal antibodies. Curr Opin Biotechnol 20(6):722-729
28. Gibbs J (2010) Prediction of exposure-response relationships to support first-in-human study design. AAPS J 12(4):750-758
29. FDA (2005) Estimating the maximum safe starting dose in initial clinical trials for theurapeutics in adult healthy volunteers. Guidance for Industry, Washington, DC
30. McAneney H, O'Rourke SFC (2007) Investigation of various growth mechanisms of solid tumour growth within the linear-quadratic model for radiotherapy. Phys Med Biol 52(4):1039-1054
31. Norton L (2005) Conceptual and practical implications of breast tissue geometry: toward a more effective, less toxic therapy. Oncologist 10(6):370-381. doi: 10.1634/theoncologist.10-6-370
32. Campbell A, Sivakumaran T, Davidson M, Lock M, Wong E (2008) Mathematical modeling of liver metastases tumour growth and control with radiotherapy. Phys Med Biol 53(24):7225-7239
33. NIH (2002) Institutional animal care and use committee guidebook. National Institutes of Health, Office of Laboratory Animal Welfare
34. Haddish Berhane N, Lin J, Betts A, Kuhn M, King B, Roberts E, Irvine B, Hanna D (2010) Use of preclinical pharmacokinetic/pharmacodynamic (PK/PD) modeling early on in antibacterial drug discovery using in vitro data development In: ICAAC 2010, Boston, MA
35. Leal M (2012) Pre-clinical PK and disposition of calicheamicin and auristatin-based antibody-drug conjugates. In: National biotechnology conference, San Diego, CA, May 21-23, 2012
36. Shah DK, Haddish-Berhane N, Betts A (2012) Bench to bedside translation of antibody drug conjugates using a mechanistic PK/PD model: a case study with SGN-35. J Pharmacokinet Pharmacodyn 39(6):643-659