Phase i dose-escalation study of MEDI-573, a bispecific, antiligand monoclonal antibody against IGFI and IGFII, in patients with advanced solid tumors

Clinical Cancer Research

Volumn 20, Issue 18, 2014, Pages 4747-4757

  Haluska, Paul ^a   Menefee, Michael ^b   Plimack, Elizabeth R ^c   Rosenberg, Jonathan ^d,h   Northfelt, Donald ^e   LaVallee, Theresa ^f,i   Shi, Li ^f   Yu, Xiang Qing ^f   Burke, Patricia ^f   Huang, Jaiqi ^f   Viner, Jaye ^f,j   McDevitt, Jennifer ^f   LoRusso, Patricia ^g  

^a MAYO CLINIC   (United States)

^b MAYO CLINIC   (United States)

^c FOX CHASE CANCER CENTER   (United States)

^d DANA FARBER CANCER INSTITUTE   (United States)

^e MAYO CLINIC   (United States)

^f MEDIMMUNE   (United States)

^g KARMANOS CANCER INSTITUTE   (United States)

^h MEMORIAL SLOAN KETTERING CANCER CENTER   (United States)

ⁱ Kolltan Pharmaceuticals   (United States)

^j CURIS INC   (United States)

more..

Author keywords

[No Author keywords available]

Indexed keywords

ANTINEOPLASTIC AGENT; BISPECIFIC ANTIBODY; MONOCLONAL ANTIBODY; SOMATOMEDIN B; SOMATOMEDIN C;

AGED; ANTAGONISTS AND INHIBITORS; CLINICAL TRIAL; DOSE RESPONSE; FEMALE; HUMAN; MALE; MAXIMUM TOLERATED DOSE; MIDDLE AGED; MULTICENTER STUDY; NEOPLASMS; PHASE 1 CLINICAL TRIAL;

AGED; ANTIBODIES, BISPECIFIC; ANTIBODIES, MONOCLONAL; ANTINEOPLASTIC AGENTS; DOSE-RESPONSE RELATIONSHIP, DRUG; FEMALE; HUMANS; INSULIN-LIKE GROWTH FACTOR I; INSULIN-LIKE GROWTH FACTOR II; MALE; MAXIMUM TOLERATED DOSE; MIDDLE AGED; NEOPLASMS;

EID: 84907917177     PISSN: 10780432     EISSN: 15573265     Source Type: Journal    
DOI: 10.1158/1078-0432.CCR-14-0114     Document Type: Article

References (55)

1. Pollak M. The insulin and insulin-like growth factor receptor family in neoplasia: an update. Nat Rev Cancer 2012;12:159-69.
2. Perks CM, Holly JM. IGF binding proteins (IGFBPs) and regulation of breast cancer biology. J Mammary Gland Biol Neoplasia 2008;13: 455-69.
3. Baserga R, Peruzzi F, Reiss K. The IGF-1 receptor in cancer biology. Int J Cancer 2003;107:873-7.
4. Frasca F, Pandini G, Scalia P, Sciacca L, Mineo R, Costantino A, et al. Insulin receptor isoformA, a newly recognized, high-affinity insulin-like growth factor II receptor in fetal and cancer cells. Mol Cell Biol 1999;19: 3278-88.
5. Schmidt B, Kiecke-Siemsen C, Waheed A, Braulke T, von FK. Localization of the insulin-like growth factor II binding site to amino acids 1508-1566 in repeat 11 of the mannose 6-phosphate/insulin-like growth factor II receptor. J Biol Chem 1995;270:14975-82.
6. Soos MA, Whittaker J, Lammers R, Ullrich A, Siddle K. Receptors for insulin and insulin-like growth factor-I can form hybrid dimers. Characterisation of hybrid receptors in transfected cells. Biochem J 1990; 270:383-90.
7. Samani AA, Yakar S, LeRoith D, Brodt P. The role of the IGF system in cancer growth and metastasis: overview and recent insights. Endocr Rev 2007;28:20-47.
8. Metalli D, Lovat F, Tripodi F, Genua M, Xu SQ, Spinelli M, et al. The insulin-like growth factor receptor I promotes motility and invasion of bladder cancer cells through Akt-and mitogen-activated protein kinase-dependent activation of paxillin. Am J Pathol 2010;176: 2997-3006.
9. Zhao H, Grossman HB, Spitz MR, Lerner SP, Zhang K, Wu X. Plasma levels of insulin-like growth factor-1 and binding protein-3, and their association with bladder cancer risk. J Urol 2003;169:714-7.
10. Gallagher EM, O'Shea DM, Fitzpatrick P, Harrison M, Gilmartin B, Watson JA, et al. Recurrence of urothelial carcinoma of the bladder: a role for insulin-like growth factor-II loss of imprinting and cytoplasmic E-cadherin immunolocalization. Clin Cancer Res 2008;14:6829-38.
11. Rochester MA, Patel N, Turney BW, Davies DR, Roberts IS, Crew J, et al. The type 1 insulin-like growth factor receptor is over-expressed in bladder cancer. BJU Int 2007;100:1396-401.
12. Parisot JP, Hu XF, DeLuise M, Zalcberg JR. Altered expression of the IGF-1 receptor in a tamoxifen-resistant human breast cancer cell line. Br J Cancer 1999;79:693-700.
13. Knowlden JM, Hutcheson IR, Barrow D, Gee JM, Nicholson RI. Insulinlike growth factor-I receptor signaling in tamoxifen-resistant breast cancer: a supporting role to the epidermal growth factor receptor. Endocrinology 2005;146:4609-18.
14. Hou X, Huang F, Macedo LF, Harrington SC, Reeves KA, Greer A, et al. Dual IGF-1R/InsR inhibitor BMS-754807 synergizes with hormonal agents in treatment of estrogen-dependent breast cancer. Cancer Res 2011;71:7597-607.
15. Lee AV, Weng CN, Jackson JG, Yee D. Activation of estrogen receptormediated gene transcription by IGF-I in human breast cancer cells. J Endocrinol 1997;152:39-47.
16. Cortot AB, Repellin CE, Shimamura T, Capelletti M, Zejnullahu K, Ercan D, et al. Resistance to irreversible EGF receptor tyrosine kinase inhibitors through a multistep mechanism involving the IGF1R pathway. Cancer Res 2013;73:834-43.
17. Lu Y, Zi X, Zhao Y, Mascarenhas D, Pollak M. Insulin-like growth factor-I receptor signaling and resistance to trastuzumab (Herceptin). J Natl Cancer Inst 2001;93:1852-7.
18. Buck E, Eyzaguirre A, Rosenfeld-Franklin M, Thomson S, Mulvihill M, Barr S, et al. Feedback mechanisms promote cooperativity for small molecule inhibitors of epidermal and insulin-like growth factor receptors. Cancer Res 2008;68:8322-32.
19. Duan Z, Choy E, Harmon D, Yang C, Ryu K, Schwab J, et al. Insulinlike growth factor-I receptor tyrosine kinase inhibitor cyclolignan picropodophyllin inhibits proliferation and induces apoptosis in multidrug resistant osteosarcoma cell lines. Mol Cancer Ther 2009; 8:2122-30.
20. Atzori F, Tabernero J, Cervantes A, Prudkin L, Andreu J, Rodriguez-Braun E, et al. A phase I pharmacokinetic and pharmacodynamic study of dalotuzumab (MK-0646), an anti-insulin-like growth factor-1 receptor monoclonal antibody, in patients with advanced solid tumors. Clin Cancer Res 2011;17:6304-12.
21. Haluska P, Hou X, Huang F, Harrington S, Greer A, Macedo L, et al. Complete IGF signaling blockade by the dual-kinase inhibitor, BMS-754807, is sufficient to overcome tamoxifen and letrozole resistance in vitro and in vivo [abstract 402]. Cancer Res 2009;69:402.
22. Kurzrock R, Patnaik A, Aisner J, Warren T, Leong S, Benjamin R, et al. A phase I study of weekly R1507, a human monoclonal antibody insulinlike growth factor-I receptor antagonist, in patients with advanced solid tumors. Clin Cancer Res 2010;16:2458-65.
23. Reidy DL, Vakiani E, Fakih MG, Saif MW, Hecht JR, Goodman-Davis N, et al. Randomized, phase II study of the insulin-like growth factor-1 receptor inhibitor IMC-A12, with or without cetuximab, in patients with cetuximab-or panitumumab-refractory metastatic colorectal cancer. J Clin Oncol 2010;28:4240-6.
24. Tolcher AW, Sarantopoulos J, Patnaik A, Papadopoulos K, Lin CC, Rodon J, et al. Phase I, pharmacokinetic, and pharmacodynamic study of AMG 479, a fully human monoclonal antibody to insulin-like growth factor receptor, J Clin Oncol 2009;27:5800-7.
25. Harrington SC, Weroha SJ, Reynolds C, Suman VJ, Lingle WL, Haluska P. Quantifying insulin receptor isoform expression in FFPE breast tumors. Growth Horm IGF Res 2012;22:108-15.
26. Huang J, Morehouse C, Streicher K, Higgs BW,Gao J, Czapiga M, et al. Altered expression of insulin receptor isoforms in breast cancer. PLoS ONE 2011;6:e26177.
27. Kalli KR, Falowo OI, Bale LK, Zschunke MA, Roche PC, Conover CA. Functional insulin receptors on human epithelial ovarian carcinoma cells: implications for IGF-II mitogenic signaling. Endocrinology 2002; 143:3259-67.
28. Avnet S, Sciacca L, Salerno M, Gancitano G, Cassarino MF, Longhi A, et al. Insulin receptor isoform A and insulin-like growth factor II as additional treatment targets in human osteosarcoma. Cancer Res 2009;69:2443-52.
29. Wahner Hendrickson AE, Haluska P, Schneider PA, Loegering DA, Peterson KL, Attar R, et al. Expression of insulin receptor isoform A and insulin-like growth factor-1 receptor in human acute myelogenous leukemia: effect of the dual-receptor inhibitor BMS-536924 in vitro. Cancer Res 2009;69:7635-43.
30. Vella V, Pandini G, Sciacca L, Mineo R, Vigneri R, Pezzino V, et al. A novel autocrine loop involving IGF-II and the insulin receptor isoform-A stimulates growth of thyroid cancer. J Clin Endocrinol Metab 2002; 87:245-54.
31. Sciacca L, Mineo R, Pandini G, Murabito A, Vigneri R, Belfiore A. In IGFI receptor-deficient leiomyosarcoma cells autocrine IGF-II induces cell invasion and protection from apoptosis via the insulin receptor isoform A. Oncogene 2002;21:8240-50.
32. Cox ME, Gleave ME, Zakikhani M, Bell RH, Piura E, Vickers E, et al. Insulin receptor expression by human prostate cancers. Prostate 2009;69:33-40.
33. Gao J, Chesebrough JW, Cartlidge SA, Ricketts SA, Incognito L, Veldman-Jones M, et al. Dual IGF-I/II-neutralizing antibody MEDI-573 potently inhibits IGF signaling and tumor growth. Cancer Res 2011;71:1029-40.
34. Therasse P, Arbuck SG, Eisenhauer EA, Wanders J, Kaplan RS, Rubinstein L, et al. New guidelines to evaluate the response to treatment in solid tumors. European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada. J Natl Cancer Inst 2000;92: 205-16.
35. Bao H, Burke PA, Huang J, Chen X, Brohawn PZ, Yao Y, et al. Circulating tumor cells: application as a biomarker for molecular characterization and predictor of survival in an all-comer solid tumor phase I clinical study. PLoS ONE 2013;8:e58557.
36. Hayes DF, Cristofanilli M, Budd GT, Ellis MJ, Stopeck A, Miller MC, et al. Circulating tumor cells at each follow-up time point during therapy of metastatic breast cancer patients predict progression-free and overall survival. Clin Cancer Res 2006;12:4218-24.
37. de Bono JS, Scher HI, Montgomery RB, Parker C, Miller MC, Tissing H, et al. Circulating tumor cells predict survival benefit from treatment in metastatic castration-resistant prostate cancer. Clin Cancer Res 2008;14:6302-9.
38. Cohen SJ, Punt CJ, Iannotti N, Saidman BH, Sabbath KD, Gabrail NY, et al. Relationship of circulating tumor cells to tumor response, progression-free survival, and overall survival in patients with metastatic colorectal cancer. J Clin Oncol 2008;26:3213-21.
39. Cohen SJ, Punt CJ, Iannotti N, Saidman BH, Sabbath KD, Gabrail NY, et al. Prognostic significance of circulating tumor cells in patients with metastatic colorectal cancer. Ann Oncol 2009;20:1223-9.
40. Gualberto A, Pollak M. Emerging role of insulin-like growth factor receptor inhibitors in oncology: early clinical trial results and future directions. Oncogene 2009;28:3009-21.
41. Cohen BD, Baker DA, SoderstromC, Tkalcevic G, Rossi AM, Miller PE, et al. Combination therapy enhances the inhibition of tumor growth with the fully human anti-type 1 insulin-like growth factor receptor monoclonal antibody CP-751,871. Clin Cancer Res 2005;11:2063-73.
42. Broussas M, Dupont J, Gonzalez A, Blaecke A, Fournier M, Corvaia N, et al. Molecular mechanisms involved in activity of h7C10, a humanized monoclonal antibody, to IGF-1 receptor. Int J Cancer 2009;124: 2281-93.
43. Beltran PJ, Mitchell P, Chung YA, Cajulis E, Lu J, Belmontes B, et al. AMG 479, a fully human anti-insulin-like growth factor receptor type I monoclonal antibody, inhibits the growth and survival of pancreatic carcinoma cells. Mol Cancer Ther 2009;8:1095-105.
44. Goodwin PJ, Ennis M, Pritchard KI, Trudeau ME, Koo J, Madarnas Y, et al. Fasting insulin and outcome in early-stage breast cancer: results of a prospective cohort study. J Clin Oncol 2002;20:42-51.
45. Law JH, Habibi G, Hu K, Masoudi H, Wang MY, Stratford AL, et al. Phosphorylated insulin-like growth factor-i/insulin receptor is present in all breast cancer subtypes and is related to poor survival. Cancer Res 2008;68:10238-46.
46. Ma J, Li H, Giovannucci E, Mucci L, Qiu W, Nguyen PL, et al. Prediagnostic body-mass index, plasma C-peptide concentration, and prostate cancer-specific mortality in men with prostate cancer: a longterm survival analysis. Lancet Oncol 2008;9:1039-47.
47. Mathieu MC, Clark GM, Allred DC, Goldfine ID, Vigneri R. Insulin receptor expression and clinical outcome in node-negative breast cancer. Proc Assoc Am Physicians 1997;109:565-71.
48. Wolpin BM, Meyerhardt JA, Chan AT, Ng K, Chan JA, Wu K, et al. Insulin, the insulin-like growth factor axis, and mortality in patientswith nonmetastatic colorectal cancer. J Clin Oncol 2009;27:176-85.
49. Zhang H, Pelzer AM, Kiang DT, Yee D. Down-regulation of type I insulin-like growth factor receptor increases sensitivity of breast cancer cells to insulin. Cancer Res 2007;67:391-7.
50. Gradilone A, Petracca A, Nicolazzo C, Gianni W, Cortesi E, Naso G, et al. Prognostic significance of survivin-expressing circulating tumour cells in T1G3 bladder cancer. BJU Int 2010;106:710-5.
51. Rink M, Chun FK, Dahlem R, Soave A, Minner S, Hansen J, et al. Prognostic role and HER2 expression of circulating tumor cells in peripheral blood of patients prior to radical cystectomy: a prospective study. Eur Urol 2012;61:810-7.
52. Hoogwerf D, van DJ, Maartense E. The insulin-like growth factorsystem in a patient with diffuse large B-cell non-Hodgkin's lymphoma and lactic acidosis. Ann Clin Biochem 2013;50:169-72.
53. Koga T, Endo H, Miyamoto Y, Mukai M, Akira S, Inoue M. IGFBPs contribute to survival of pancreatic cancer cells under severely hypoxic conditions. Cancer Lett 2008;268:82-8.
54. Koong AC, Denko NC, Hudson KM, Schindler C, Swiersz L, Koch C, et al. Candidate genes for the hypoxic tumor phenotype. Cancer Res 2000;60:883-7.
55. Robertson JF, Ferrero JM, Bourgeois H, Kennecke H, de Boer RH, Jacot W, et al. Ganitumab with either exemestane or fulvestrant for postmenopausal women with advanced, hormone-receptor-positive breast cancer: a randomised, controlled, double-blind, phase 2 trial. Lancet Oncol 2013;14:228-35.