Antibody drug conjugates: lessons from 20 years of clinical experience

Annals of Oncology

Volumn 27, Issue 12, 2016, Pages 2168-2172

  Tolcher, A W ^a  

^a South Texas Accelerated Research Therapeutics (START)   (United States)

Author keywords

ADC; antibody drug conjugate

Indexed keywords

ANTIBODY CONJUGATE; ANTINEOPLASTIC AGENT; DRUG; MONOCLONAL ANTIBODY;

CHEMISTRY; DRUG DELIVERY SYSTEM; HUMAN; IMMUNOLOGY; NEOPLASM;

ANTIBODIES, MONOCLONAL, HUMANIZED; ANTINEOPLASTIC AGENTS; DRUG DELIVERY SYSTEMS; HUMANS; IMMUNOCONJUGATES; NEOPLASMS; PHARMACEUTICAL PREPARATIONS;

EID: 85015198940     PISSN: 09237534     EISSN: 15698041     Source Type: Journal    
DOI: 10.1093/annonc/mdw424     Document Type: Article

References (41)

1. Diamantis, N., Banerji, U., Antibody-drug conjugate—an emerging class of cancer treatment. Br J Cancer 114 (2015), 362–367.
2. Bouchard, H., Viskov, C., Garcia-Echeverria, C., Antibody-drug conjugates—a new wave of cancer drugs. Bioorganic Med. Chem Lett 24 (2014), 5357–5363.
3. Trail, P.A., Willner, D., Lasch, S.J., et al. Cure of xenografted human carcinomas by BR96-doxorubicin immunoconjugates. Science 261:5118 (1993), 212–215.
4. LoRusso, P.M., Lomen, P.L., Redman, B.G., et al. Phase I study of monoclonal antibody-ricin A chain immnoconjugate Xomazyme-791 in patients with metastatic colon cancer. Am J Clin Oncol 18:4 (1995), 307–312.
5. Pai, L.H., Wittes, R., Setser, A., et al. Treatment of advanced solid tumorswith immunotoxin LMB-1: An antibody linked to pseudomonas exotoxin. Nat Med 2:3 (1996), 350–353.
6. Engert, A., Diehl, V., Schnell, R., et al. A phase I study of an anti-CD25 ricin A-chain immunotoxin (RFT5-SMPT-dgA) in patients with refractory Hodgkin's lymphoma. Blood 89:2 (1997), 403–410.
7. Giantonio, B.J., Alpaugh, R.K., Schultz, J., et al. Superantigen-based immunotherapy: a phase I trial of PNU-214565, a monoclonal antibody-staphylacoccal enterotoxin A recombinant fusion protein, in advanced pancreatic and colorectal cancer. Am J Clin Oncol 15:5 (1997), 1994–2007.
8. Lynch, T.J. Jr, Lambert, J.M., Coral, F., et al. Immunotoxin therapy of small-cell lung cancer: a phase I study of N901-blocked ricin. Am J Clin Oncol 15:2 (1997), 723–734.
9. Comereski, C.R., Peden, W.M., Davidson, T.J., et al. BR96-doxorubicin conjugate (BMS-182248) versus doxorubicin: a comparative toxicity assessment in rats. Toxicol Pathol 22:5 (1994), 473–488.
10. Drug Formulary, Cancer Care Ontario. 2014 (19 May 2016, date last accessed) https://www.cancercare.on.ca/CCO_DrugFormulary/Pages/dfPdfContent.aspx?itemId=93879.
11. Gabrilovich, D., Tumor antigens. Merck Manual: Professional Version. 2016 15 June 2016, date last accessed) https://www.merckmanuals.com/professional/hematology-and-oncology/tumor-immunology/tumor-antigens.
12. Neri, B., Cini-Neri, G., Bandinelli, M., et al. Doxorubicin and epirubicin cardiotoxicity: Experimental and clinical aspects. Int J Clin Pharmacol Ther Toxicol, 27, 1989, 217.
13. Saleh, M.N., Sugarman, S., Murray, J., et al. Phase I trial of the anti-Lewis Y drug immunoconjugate BR96-doxorubicin in patients with lewis Y-expression epithelial tumors. J Clin Oncol 18:11 (2000), 2282–2292.
14. Tolcher, A.W., Sugarman, S., Gelmon, K.A., et al. Randomized phase II study of BR96-doxorubicin conjugate in patients with metastatic breast cancer. J Clin Oncol 17:2 (1999), 478–484.
15. Ajani, J.A., Kelsen, D.R., Haller, D., et al. A multi-institutional phase II study of BMS-182248-01 (BR96-doxorubicin conjugate) administration every 21 days in patients with advanced gastric adenocarcinoma. Cancer J 6:2 (2000), 78–81.
16. Tjink, B.M., Buter, J., deBree, R., et al. Phase I dose escalation study with anti-CD44v6 bivatuzumab mertansine in patients with incurable squamous cell carcinoma of the head and neck or esophagus. Clin Cancer Res 12 (2006), 6064–6072.
17. Clinical Study Report No.: PH-37705/12671, Bayer Healthcare. 2014.
18. Becher, O.J., Holland, E.C., Genetically engineered models have advantages over xenografts for preclinical studies. Cancer Res 66 (2006), 3355–3358.
19. Rowinsky, E.K., Donehower, R.D., Paclitaxel (taxol). N Engl J Med 332 (1995), 1004–1014.
20. Blum, R.H., Kahlert, T., Maytansine: a phase I study of an ansa macrolide with antitumor activity. Cancer Treat Rep 62:3 (1978), 435–438.
21. Blum, R.H., Wittenberg, B.K., Canellos, G.P., et al. A therapeutic trial of maytansine. Cancer Clin Trials 1:2 (1978), 113–117.
22. Cabanillas, F., Rodriguez, V., Hall, S.W., et al. Phase I study of maytansine using a 3-day schedule. Cancer Treat Rep 62:3 (1978), 425–428.
23. Chabner, B.A., Levine, A.S., Kohnson, B.L., et al. Initial clinical trials of maytansine, an antitumor plant alkaloid. Cancer Treat Rep 62:3 (1978), 429–433.
24. O'Connell, M.J., Shani, A., Rubin, J., et al. Phase II trial of maytansine in patients with advanced colorectal carcinoma. Cancer Treat Rep 62:8 (1978), 1237–1238.
25. Gralla, R., Harper, P., Johnson, S., et al. Vinorelbine (Navelbine) in the treatment of non-small-cell lung cancer: studies with single-agent therapy and in combination with cisplatin. Ann Oncol 10:Suppl. 5 (1999), S41–S45.
26. Budman, D.R., Vinorelbine (Navalbine): a third-generation vinca alkaloid. Cancer Invest 15:5 (1997), 475–490.
27. Carrigan, C., Zuany-Amorim, C., Mayo, M., et al. Preclinical evaluation of SAR566658 (huDS6-DM4) in mice bearing human tumor xenografts of breast, ovarian, lung, cervical and pancreatic cancer. Eur J Cancer, 6, 2008, 166.
28. Donaghy, H., Effects of antibody, drug and linker on the preclinical and clinical toxicities of antibody-drug conjugates. mAbs 8:4 (2016), 659–671.
29. Eaton, J.S., Miller, P.E., Mannis, M.J., et al. Ocular adverse events associated with antibody drug conjugates in human clinical trials. J Ocul Pharmacol Ther 31 (2015), 589–604.
30. Al-Tweigeri, T., Nabholtz, J.M., Mackey, J.R., Ocular toxicity and cancer chemotherapy: a review. Cancer 78 (1996), 1359–1373.
31. Feld, J., Barta, S.K., Schinke, C., et al. Linked-in: design and efficacy of antibody drug conjugates in oncology. Oncotarget 4:3 (2013), 397–412.
32. Krop, I.E., LoRusso, P., Miller, K.D., 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 (2012), 3234–3241.
33. Chabner, B.A., Roberts, T.G. Jr, Timeline: chemotherapy and the war on cancer. Nat Rev Cancer 5 (2005), 65–72.
34. Wall, M.E., Wani, M.C., Camptothecin and taxol: discovery to clinic—thirteenth Bruce F.: cain memorial award lecture. Cancer Res 55 (1995), 753–760.
35. Frei, E. III, Holland, J.F., Schneiderman, M.A., et al. A comparative study of two regimens of combination chemotherapy in acute leukemia. Blood 13 (1958), 1126–1148.
36. Skipper, H.E., Schabel, F.M. Jr, Wilcox, W.S., Experimental evaluation of potential anticancer agents. Xiii. On the criteria and kinetics associated with “curability” of experimental leukemia. Cancer Chemother Rep 35 (1964), 1–11137.
37. Freireich, E.J., Karon, M., Frei, E. III, Quaruple combination therapy (VAMP) for acute lymphocytic leukemia of childhood. Proc Am Assoc Cancer Res, 5, 1963, 20.
38. Guo, J., Kumar, S., Chipley, M., et al. Characterization and higher-order structure assessment of an interchain cysteine-based ADC: impact of drug loading and distribution on the mechanism of aggregation. Bioconjugate Chem 27:3 (2016), 604–615.
39. ADC Review, PEG Linkers. 2015 J Antibody Drug Conjugates (20 May 2016, date last accessed) http://adcreview.com/adc-university/adcs-101/stable-linker-technologies/peg-linkers/.
40. Yurkovetskiy, A.V., Yin, M., Bodyak, N., et al. A polymer-based antibody-vinca drug conjugate platform: characterization and preclinical efficacy. Cancer Res 75:16 (2015), 3365–3372.
41. Cizeau, J., Grenkow, D.M., Brown, J.G., Entwistle, J., MacDonald, G.C., Engineering and biological characterization of VB6-845, an anti-EpCAM immunotoxin containing a T-cell epitope-depleted variant of the plant toxin bouganin. J Immunother (1991) 32 (2009), 574–584.