PK assays for antibody-drug conjugates: Case study with ado-trastuzumab emtansine

Bioanalysis

Volumn 5, Issue 9, 2013, Pages 1025-1040

  Dere, Randall ^a   Yi, Joo Hee ^a   Lei, Corinna ^a   Saad, Ola M ^a   Huang, Catherine ^a   Li, Yanhong ^a   Baudys, Jakub ^b   Kaur, Surinder ^a  

^a GENENTECH INC   (United States)

^b CENTERS FOR DISEASE CONTROL AND PREVENTION   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

TRASTUZUMAB EMTANSINE;

ACCURACY; ANIMAL EXPERIMENT; ARTICLE; BREAST CANCER; CASE STUDY; CLINICAL ARTICLE; CONTROLLED STUDY; DILUTION; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG DOSE ESCALATION; DRUG HALF LIFE; ENZYME LINKED IMMUNOSORBENT ASSAY; HUMAN; LIQUID CHROMATOGRAPHY; MASS SPECTROMETRY; MULTICENTER STUDY; NONHUMAN; OPEN STUDY; PHASE 1 CLINICAL TRIAL; QUANTITATIVE ANALYSIS;

ANTIBODIES, MONOCLONAL; ANTIBODIES, MONOCLONAL, HUMANIZED; CHROMATOGRAPHY, LIQUID; DRUG DESIGN; ENZYME-LINKED IMMUNOSORBENT ASSAY; IMMUNOCONJUGATES; MASS SPECTROMETRY; MAYTANSINE;

EID: 84877260358     PISSN: 17576180     EISSN: 17576199     Source Type: Journal    
DOI: 10.4155/bio.13.72     Document Type: Article

References (29)

1. Carter PJ, Senter PD. Antibody-drug conjugates for cancer therapy. Cancer J. 14(3), 154-169 (2008).
2. Schrama D, Reisfeld RA, Becker JC. Antibody targeted drug as cancer therapeutics. Nat. Rev. Drug Discov. 5(2), 147-159 (2006).
3. Polakis P. Arming antibodies for cancer therapy. Curr. Opin. Pharmacol. 5(4), 382-387 (2005).
4. Alley SC, Okeley NM, Senter PD. Antibody-drug conjugates: targeted drug delivery for cancer. Curr. Opin. Chem. Biol. 14(4), 529-537 (2010).
5. Ryan MC, Kostner H, Gordon KA et al. Targeting pancreatic and ovarian carcinomas using the auristatin-based anti-CD70 antibody-drug conjugate SGN-75. Br. J. Cancer 103(5), 676-684 (2010).
6. Wang X, Ma D, Olson W, Heston WDW. In vitro and in vivo responses of advanced prostate tumors to PSMA ADC, an auristatin-conjugated antibody to prostate-specific membrane antigen. Mol. Cancer Ther. 10(9), 1728-1739 (2011).
7. Younes A, Kim S, Romaguera J 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. 30(22), 2776-2782 (2012).
8. Yarden Y, Sliwkowski MX. Untangling the ErbB signalling network. Nat. Rev. Mol. Cell. Biol. 2(2), 127-137 (2001).
9. Slamon DJ, Clark GM, Wong SG, Levin WJ, Ullrich A, McGuire WL. Human breast cancer: correlation of relapse and survival with amplification of the HER-2/neu oncogene. Science 235(4785), 177-182 (1987).
10. Slamon DJ, Godolphin W, Jones LA et al. Studies of the HER-2/neu proto-oncogene in human breast and ovarian cancer. Science 244(4905), 707-712 (1989).
11. Nahta R, Yu D, Hung MC, Hortobagyi GN, Esteva FJ. Mechanisms of disease: understanding resistance to HER2-targeted therapy in human breast cancer. Nat. Clin. Pract. Oncol. 3(5), 269-280 (2006).
12. Slamon DJ, Leyland-Jones B, Shak S et al. Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2. N. Engl. J. Med. 344(11), 783-792 (2001).
13. Xu K, Liu L, Saad OM, Baudys J et al. Characterization of intact antibody-drug conjugates from plasma/serum in vivo by affinity capture capillary liquid chromatography-mass spectrometry. Anal. Biochem. 412(1), 56-66 (2011).
14. Shen BQ, Xu K, Liu L et al. Conjugation site modulates the in vivo stability and therapeutic activity of antibody-drug conjugates. Nat. Biotechnol. 30(2), 184-189 (2012).
15. Kaur S, Xu K, Saad O et al. A perspective on bioanalytical assay strategies for the development of antibody-drug conjugate biotherapeutics. Bioanalysis 5(2), 201-226 (2013).
16. Shen BQ, Bumbaca D, Saad O et al. Catabolic fate and pharmacokinetic characterization of trastuzumab emtansine: an emphasis on preclinical and clinical catabolism. Curr. Drug Metab. 13(7), 901-910 (2012).
17. Girish S, Gupta M, Wang B et al. Clinical pharmacology of T-DM1: an anti-body-drug conjugate in development for the treatment of HER2-positive cancer. Cancer Chemother. Pharmacol. 69(5), 1229-1240 (2012).
18. Phillips GDL, Li G, Dugger DL et al. Targeting HER2-positive breast cancer with trastuzumab-DM1, an antibody-cytotoxic drug conjugate. Cancer Res. 68(22), 9280-9290 (2008).
19. Sanderson RJ, Hering MA, James SF et al. In vivo drug-linker stability of anti-CD30 dipeptide-linked auristatin immunoconjugate. Clin. Cancer Res. 11(2 Pt 1), 843-852 (2005).
20. Fishkin N, Maloney EK, Chari RV, Singh R. A novel pathway for maytansinoid release from thioether linked antibody-drug conjugates (ADCs) under oxidative conditions. Chem. Commun. 47, 10752-10754 (2011).
21. Krop IE, Beeram M, Modi S 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. 28(16), 2698-2704 (2010).
22. Hamblett KJ, Senter PD, Chace DF et al. Effects of drug loading on the anti-tumor activity of a monoclonal antibody drug conjugate. Clin. Cancer Res. 10(20), 7063-7070 (2004).
23. Burris HA 3rd, Rugo HS, Vukelja SJ et al. 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 (2011).
24. Krop IE, LoRusso P, Miller KD et al. A Phase II study of trastuzumab emtansine in patients with human epidermal growth factor receptor 2-positive metastatic breast cancer who were previously treated with trastuzumab, lapatinib, an anthracycline, a taxane, and capecitabine. J. Clin. Oncol. 30(26), 3234-3241 (2012).
25. Beeram M, Krop IE, Buris HS et al. A Phase 1 study of weekly dosing of trastuzumab emtansine (T-DM1) in patients with advanced human epidermal growth factor 2-positive breast cancer. Cancer 118(23), 5733-5740 (2012).
26. Engvall E, Perlmann P. Enzyme-linked immunosorbent assay (ELISA). Quantitative assay of immunoglobulin G. Immunochemistry 8(9), 871-874 (1971).
27. Lequin RM. Enzyme immunoassay (EIA)/enzyme-linked immunosorbent assay (ELISA). Clin. Chem. 51(12), 2415-2418 (2005).
28. Bruno R, Washington CB, Lu J-F et al. Population pharmacokinetics of trastuzumab in patients with HER2+ metastatic breast cancer. Cancer Chemother. Pharmacol. 56, 361-369 (2005).
29. Stephan JP, Chan P, Lee C et al. Anti-CD22-MCC-DM1 and MC-MMAF conjugates: impact of assay format on pharmacokinetic parameters determination. Bioconjug. Chem. 19(8), 1673-1683 (2008).