Galiximab: A review

Expert Opinion on Biological Therapy

Volumn 10, Issue 3, 2010, Pages 451-458

  Bhat, Seema ^a   Czuczman, Myron S ^a  

^a ROSWELL PARK CANCER INSTITUTE   (United States)

Author keywords

Anti CD80; Galiximab; MAb; Non Hodgkin's lymphoma

Indexed keywords

B7 ANTIGEN; GALIXIMAB; GLYCOPROTEIN; RITUXIMAB;

ADD ON THERAPY; ANTINEOPLASTIC ACTIVITY; B CELL LYMPHOMA; CANCER COMBINATION CHEMOTHERAPY; CLINICAL TRIAL; DATA ANALYSIS; DRUG DOSE ESCALATION; DRUG EFFICACY; DRUG HALF LIFE; DRUG MECHANISM; DRUG SAFETY; DRUG TARGETING; EFFECTOR CELL; HEADACHE; HODGKIN DISEASE; HUMAN; INFORMATION RETRIEVAL; MEDICAL LITERATURE; MEDLINE; NAUSEA; NONHUMAN; PROTEIN EXPRESSION; PUBLISHING; REVIEW;

ANTIBODIES, MONOCLONAL; ANTIGENS, CD80; ANTINEOPLASTIC AGENTS; HUMANS; LYMPHOMA, NON-HODGKIN;

EID: 76949105357     PISSN: 14712598     EISSN: None     Source Type: Journal    
DOI: 10.1517/14712591003596318     Document Type: Review

References (68)

1. Jemal A, Siegel R, Ward E, et al. Cancer statistics, 2009. CA Cancer J Clin 2009;59:225-249
2. Horner MJ, Ries LAG, Krapcho M, et al., editors, SEER Cancer Statistics Review, 1975-2006. National Cancer Institute. Bethesda, MD. Available from: http://seer.cancer.gov/csr/1975-2006/, based on November 2008 SEER data submission, posted to the SEER web site, 2009
3. Ries LAG, Melbert D, Krapcho M, et al., editors, SEER Cancer Statistics Review, 1975-2005. National Cancer Institute. Bethesda, MD; 2008. Available from: http://seer.cancer.gov/csr/ 1975-2005/
4. Cancer Trends Progress Report (http://progressreport.cancer.gov), in 2004 dollars, based on methods described in Medical Care 2002;40(Suppl 8):IV-104-117
5. Kohler G, Milstein C. Continuous cultures of fused cells secreting antibody of predefined specificity. Nature 1975;256:495-497
6. Morrison SL, Johnson MJ, Herzenberg LA, et al. Chimeric human antibody molecules: mouse antigen-binding domains with human constant region domains. Proc Natl Acad Sci USA 1984;81:6851-6855
7. Leget GA, Czuczman MS. Use of rituximab, the new FDA-approved antibody. Curr Opin Oncol 1998;10:548-551
8. Czuczman MS, Grillo-Lopez AJ, White CA, et al. Treatment of patients with low grade B-cell lymphoma with the combination of chimeric anti-CD20 monoclonal antibody and CHOP chemotherapy. J Clin Oncol 1999;17:268-276
9. Forstpointner R, Unterhalt M, Dreyling M, et al. Maintenance therapy with rituximab leads to a significant prolongation of response duration after salvage therapy with a combination of rituximab, fludarabine, cyclophosphamide, and mitoxantrone (R-FCM) in patients with recurring and refractory follicular and mantle cell lymphomas: results of a prospective randomized study of the German Low Grade Lymphoma Study Group (GLSG). Blood 2006;108:4003-4008
10. Hiddemann W, Kneba M, Dreyling M, et al. Frontline therapy with rituximab added to the combination of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) significantly improves the outcome for patients with advanced-stage follicular lymphoma compared with therapy with CHOP alone: results of a prospective randomized study of the German Low-Grade Lymphoma Study Group. Blood 2005;106:3725-3732
11. Marcus R, Imrie K, Belch A, et al. CVP chemotherapy plus rituximab compared with CVP as first-line treatment for advanced follicular lymphoma. Blood 2005;105:1417-1423
12. Davis TA, Grillo-Lopez AJ, White CA, et al. Rituximab anti-CD20 monoclonal antibody therapy in non-Hodgkin's lymphoma: safety and efficacy of re-treatment. J Clin Oncol 2000;18:3135-3143
13. Foran JM, Gupta RK, Cunningham D, et al. A UK multicentre phase II study of rituximab (chimaeric anti-CD20 monoclonal antibody) in patients with follicular lymphoma, with PCR monitoring of molecular response. Br J Haematol 2000;109:81-88
14. McLaughlin P, Grillo-Lopez AJ, Link BK, et al. Rituximab chimeric anti-CD20 monoclonal antibody therapy for relapsed indolent lymphoma: half of patients respond to a four-dose treatment program. J Clin Oncol 1998;16:2825-2833
15. Piro LD, White CA, Grillo-Lopez AJ, et al. Extended rituximab (anti-CD20 monoclonal antibody) therapy for relapsed or refractory low-grade or follicular non-Hodgkin's lymphoma. Ann Oncol 1999;10:655-661
16. Coiffier B, Lepage E, Briere J, et al. CHOP chemotherapy plus rituximab compared with CHOP alone in elderly patients with diffuse large-B-cell lymphoma. N Engl J Med 2002;346:235-242
17. Gallagher CJ, Gregory WM, Jones AE, et al. Follicular lymphoma: prognostic factors for response and survival. J Clin Oncol 1986;4(10):1470-1480
18. Horning SJ Natural history of and therapy for the indolent non-Hodgkin's lymphomas. Semin Oncol 1993;20(5 Suppl 5):75-88
19. Solal-Celigny P, Roy P, Colombat P, et al. Follicular lymphoma international prognostic index. Blood 2004;104 (5):1258-1265
20. Boussiotis VA, Freedman AS, Nadler LM. Bone marrow transplantation for low-grade lymphoma and chronic lymphocytic leukemia. Semin Hematol 1999;36(2):209-216
21. Johnson PWM, Rohatiner AZS, Whelan JS, et al. Patterns of survival in patients with recurrent follicular lymphoma: a 20-year study from a single center. J Clin Oncol 1995;13(1):140-147
22. McLaughlin P. Progress and promise in the treatment of indolent lymphomas. Oncologist 2002;7(3):217-225
23. Rohatiner AZS, Price CGA, Amott S, et al. MyeIoablative therapy with autologous bone marrow transplantation as consolidation of remission in patients with follicular lymphoma. Ann Oncol 1991;2(Suppl Z):147-150
24. Cabanillas F, Hagemeister FB, McLaughlin P, et al. Results of MIME salvage regimen for recurrent or refractory lymphoma. J Clin Oncol 1987;5(3):407-412
25. Niitsu N, Umeda M. Salvage chemotherapy for relapsed or refractory non-Hodgkin's lymphoma with a combination of ACES (high-dose Ara C, carboplatin, etoposide and steroids) therapy. Eur J Haematol 1996;57(4):320-324
26. Velasquez WS, Cabanillas F, Salvador P, et al. Effective salvage therapy for lymphoma with cisplatin in combination with high-dose Ara-C and dexamethasone (DHAP). Blood 1988;71(1):117-122
27. Velasquez WS, McLaughlin P, Tucker S, et al. ESHAP - An effective chemotherapy regimen in refractory and relapsing lymphoma: a 4-year follow-up study. J Clin Oncol 1994;12(6):1169-1176
28. Czuczman MS, Koryzna A, Mohr A, et al. Rituximab in combination with Fludarabine chemotherapy in low-grade or follicular lymphoma. J Clin Oncol 2005;23(4):694-704
29. Czuczman MS, Weaver R, Alkuzweny B, et al. Prolonged clinical and molecular remission in patients with low-grade or follicular non-Hodgkin's lymphoma treated with rituximab plus CHOP chemotherapy: 9-year follow-up. J Clin Oncol 2004;22(23):4711-4716
30. van Besien K, Loberiza FR, Jr., Bajorunaite R, et al. Comparison of autologous and allogeneic hematopoietic stem cell transplantation for follicular lymphoma. Blood 2003;102(10):3521-3529
31. Young RC, Longo DL, Glatstein E. Watchful-waiting vs. aggressive combined modality therapy (Rx) in the treatment of stage III-IV indolent non-Hodgkin's lymphoma [abstract 790]. Proc Am Soc Clin Oncol 1987;6:200
32. Czuczman M. Controversies in follicular lymphoma: "Who, what, When, Where, and Why?" (not necessarily in that order¡). Hematology 2006:303-310
33. Zang X, Allison JP. The B7 family and cancer therapy: costimulation and coinhibition. Clin Cancer Res 2007;13:5271
34. Gordon J, Millsum MJ, Guy GR, Ledbetter JA. Resting B lymphocytes can be triggered directly through the CDw40 (Bp50) antigen. A comparison with IL-4-mediated signaling. J Immunol 1988;140:1425-1430
35. Goldstein MD, Watts TH. Identification of distinct domains in CD40 involved in B7-1 induction or growth inhibition. J Immunol 1996;157:2837-2843
36. Nakajima A, Kodama T, Morimoto S, et al. Antitumor effect of CD40 ligand: elicitation of local and systemic antitumor responses by IL-12 and B7. J Immunol 1998;161:1901-1907
37. Bergamo A, Bataille R, Pellat-Deceunynck C. CD40 and CD95 induce programmed cell death in the human myeloma cell line XG2. Br J Haematol 1997;97:652-655
38. Coyle AJ, Gutierrez-Ramos JC. The expanding B7 superfamily: increasing complexity in costimulatory signals regulating T cell function. Nat Immunol 2001;2:203-209
39. Dorfman DM, Schultze JL, Shahsafaei A, et al. In vivo expression of B7-1 and B7-2 by follicular lymphoma cells can prevent induction of T-cell anergy but is insufficient to induce significant T-cell proliferation. Blood 1997;90:4297-4306
40. Vyth-Dreese FA, Boot H, Dellemijn TA, et al. Localization in situ of costimulatory molecules and cytokines in B-cell non-Hodgkin's lymphoma. Immunology 1998;94:580-586
41. Chambers CA, Allison JP. Costimulatory regulation of T cell function. Curr Opin Cell Biol 1999; 11:203-210
42. Sansom DM, Walker LS. The role of CD28 and cytotoxic T-lymphocyte antigen-4 (CTLA-4) in regulatory T-cell biology. Immunol Rev 2006;212:131-148
43. Brunet JF, Denizot F, Luciani MF, et al. A new member of the immunoglobulin superfamily-CTLA-4. Nature 1987;328:267-270
44. Girvin AM, Dal Canto MC, Rhee L, et al. A critical role for B7/CD28 costimulation in experimental autoimmune encephalomyelitis: a comparative study using costimulatory molecule-deficient mice and monoclonal antibody blockade. J Immunol 2000;164:136-143
45. Mathur M, Herrmann K, Qin Y, et al. CD28 interactions with either CD80 or CD86 are sufficient to induce allergic airway inflammation in mice. Am J Respir Cell Mol Biol 1999;21:498-509
46. Oliveira-dos-Santos AJ, Ho A, Tada Y, et al. CD28 costimulation is crucial for the development of spontaneous autoimmune encephalomyelitis. J Immunol 1999;162:4490-4495
47. Tada Y, Nagasawa K, Ho A, et al. Role of the costimulatory molecule CD28 in the development of lupus in MRL/lpr mice. J Immunol 1999;163:3153-3159
48. Waterhouse P, Penninger JM, Timms E, et al. Lymphoproliferative disorders with early lethality in mice deficient in CTLA-4. Science 1995;270:985-988
49. Suvas S, Singh V, Sahdev S, et al. Distinct role of CD80 and CD86 in the regulation of the activation of B cell and B cell lymphoma. J Biol Chem. 2002; 277:7766-7775
50. Gajewski TF, Fallarino F, Uyttenhove C, Boon T. J Immunol 1996;156:2909-2917
51. Schattner EJ, Elkon KB, Yoo DH, et al. J Exp Med 1995;182:1557-1565
52. Munro JM, Freedman AS, Aster JC, et al. In vivo expression of the B7 costimulatory molecule by subsets of antigen-presenting cells and the malignant cells of Hodgkin's disease. Blood 1994;83:793-798
53. Dogan A, Du MQ, Aiello A, et al. Follicular lymphomas contain a clonally linked but phenotypically distinct neoplastic B-cell population in the interfollicular zone. Blood 1998;91:4708-4714
54. Younes A, Hariharan K, Allen RS, Leigh BR. Initial trials of anti-CD80 monoclonal antibody (Galiximab) therapy for patients with relapsed or refractory follicular lymphoma. Clin Lymphoma 2003;3:257-259
55. Hariharan HK, Berquist LG, Murphy T, et al. Therapeutic application of an anti-CD80 antibody (IDEC-114) in B-cell lymphoma. J Immunother 2002;25:S31
56. Hariharan HK, Berquist LG, Murphy TE. Anti-CD80 antibody antibody (IDEC-114) therapy for non-Hodgkin's lymphoma [abstract 287]. Ann of Oncol 2002;13(Suppl 2):84
57. Hariharan K, Anderson D, Leigh B, et al. Therapeutic activity of IDEC-114 (anti-CD80) and rituximab (Rituxan) in B-cell lymphoma [abstract 2549]. Blood 2001;98:608a
58. Gottlieb AB, Lebwohl M, Totoritis MC, et al. Clinical and histologic response to single-dose treatment of moderate to severe psoriasis with an anti-CD80 monoclonal antibody. J Am Acad Dermatol 2002;47:692-700
59. Gottlieb AB, Kang S, Linden KG, et al. Evaluation of safety and clinical activity of multiple doses of the anti-CD80 monoclonal antibody, galiximab, in patients with moderate to severe plaque psoriasis. Clin Immunol 2004;111:28-37
60. Czuczman MS, Thall A, Witzig TE, et al. Phase I/II study of galiximab, an anti-CD80 antibody, for relapsed or refractory follicular lymphoma. J Clin Oncol 2005;23:4390-4398
61. Leonard JP, Friedberg JW, Younes A, et al. A phase I/II study of galiximab (an anti-CD80 monoclonal antibody) in combination with rituximab for relapsed or refractory, follicular lymphoma. Ann Oncol 2007;18:1216-1223
62. Friedberg JW, Younes A, Fisher D, et al. Durable responses in patients treated with galiximab (anti-CD80) in combination with rituximab for relapsed or refractory follicular lymphoma: long term follow-up of a phase II clinical trial. ASH 2008 Abstract # 1004
63. Czuczman MS, Johnson JL, Jung SH, Cheson BD. A phase II trial of extended induction of galiximab [G] (anti-CD80 monoclonal antibody) plus rituximab [R] in previously untreated follicular lymphoma (FL): Initial report of CALGB study 50402. 10th International Conference on Malignant Lymphoma. Lugano, Switzerland 2008
64. Czuczman MS, Johnson J, Jung S, et al. A phase II trial of extended induction galiximab (anti-CD80 monoclonal antibody) plus rituximab in previously untreated follicular lymphoma: initial report of CALGB 50402 [abstract 143]. Ann Oncology 2008;19(Suppl 4):iv130
65. Forstpointner R, Dreyling M. Rituximab maintenance therapy in follicular lymphoma: Curr Hematol Malig Rep 2007;2(4):213-218
66. Delabie J, Ceuppens JL, Vandenberghe P, et al. The B7/BB1 antigen is expressed by Reed-Sternberg cells of Hodgkin's disease and contributes to the stimulating capacity of Hodgkin's disease-derived cell lines. Blood 1993;82:2845-2852
67. Nozawa Y, Wakasa H, Abe M. Costimulatory molecules (CD80 and CD86) on Reed-Sternberg cells are associated with the proliferation of background T cells in Hodgkin's disease. Pathol Int 1998; 48:10-14
68. Galiximab in treating patients with relapsed or refractory Hodgkin's lymphoma. Available from: http:// clinicaltrials.gov/ct2/show/ NCT00516217?term=00516217&rank=1