Ofatumumab for the treatment of chronic lymphocytic leukemia

Expert Review of Hematology

Volumn 8, Issue 3, 2015, Pages 265-272

  Grosicki, Sebastian ^a  

^a MEDICAL UNIVERSITY OF SILESIA   (Poland)

Author keywords

chronic lymphocytic leukemia; efficacy; guidelines; monoclonal antibody; ofatumumab; recommendations; safety; treatment

Indexed keywords

OFATUMUMAB; CD20 ANTIGEN; MONOCLONAL ANTIBODY;

CANCER CHEMOTHERAPY; CANCER PATIENT; CANCER REGISTRY; CHRONIC LYMPHATIC LEUKEMIA; DRUG EFFICACY; DRUG INDICATION; DRUG MECHANISM; DRUG SAFETY; DRUG TOLERABILITY; HUMAN; INFECTIOUS COMPLICATION; INFUSION RELATED REACTION; MAINTENANCE CHEMOTHERAPY; MEDICINAL CHEMISTRY; MONOTHERAPY; MULTICENTER STUDY (TOPIC); NEUTROPENIA; PHASE 1 CLINICAL TRIAL (TOPIC); PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); REVIEW; THROMBOCYTOPENIA; TREATMENT OUTCOME; VULNERABLE POPULATION; ANIMAL; CLINICAL TRIAL (TOPIC); IMMUNOLOGY; LEUKEMIA, LYMPHOCYTIC, CHRONIC, B-CELL;

ANIMALS; ANTIBODIES, MONOCLONAL; ANTIGENS, CD20; CLINICAL TRIALS AS TOPIC; HUMANS; LEUKEMIA, LYMPHOCYTIC, CHRONIC, B-CELL; MAINTENANCE CHEMOTHERAPY;

EID: 84929071974     PISSN: 17474086     EISSN: 17474094     Source Type: Journal    
DOI: 10.1586/17474086.2015.1037736     Document Type: Review

References (31)

1. Montserrat E, Moreno C. Chronic lymphocytic leukaemia: a short overview. Ann Oncol 2008;19:320-5
2. Teeling JL, Mackus WJ, Wiegman LJ, et al. The biological activity of human CD20 monoclonal antibodies linked to unique epitopes on CD20. J Immunol 2006;177:362-71
3. GlaxoSmithKline ArzerraTM prescribing information [online]. Available from: www. accessdata.fda.gov/drugsatfda-docs/label/ 2009/125326lbl.pdf [Last accessed 25 January 2010]
4. Teeling JL, French RR, Cragg MS, et al. Characterization of new human CD20 monoclonal antibodies with potent cytolytic activity against non-Hodgkin lymphomas. Blood 2004;104:1793-800
5. Pawluczkowycz AW, Beurskens FJ, Beum PV, et al. Binding of submaximal C1q promotes complement-dependent cytotoxicity (CDC) of B cells opsonized with anti-CD20 mAbs ofatumumab (OFA) or rituximab (RTX): considerably higher levels of CDC are induced by OFA than by RTX. J Immunol 2009;183:749-58
6. Middleton O, Cosimo E, Dobbin E, et al. Complement deficiencies limit CD20 monoclonal antibody treatment efficacy in CLL. Leukemia 2015;29:107-14
7. Beum PV, Lindorfer MA, Beurskens F, et al. Complement activation on B lymphocytes opsonized with rituximab or ofatumumab produces substantial changes in membrane structure preceding cell lysis. J Immunol 2008;181:822-32
8. Beum PV, Peek EM, Lindorfer MA, et al. Loss of CD20 and bound CD20 antibody from opsonized B cells occurs more rapidly because of trogocytosis mediated by Fc receptor-expressing effector cells than direct internalization by the B cells. J Immunol 2011;187:3438-47
9. Pedersen AE, Jungersen MB, Pedersen CD. Monocytes mediate shaving of B-cell-bound anti-CD20 antibodies. Immunology 2011;133:239-45
10. Taylor RP, Lindorfer MA. Analyses of CD20 monoclonal antibody-mediated tumor cell killing mechanisms: rational design of dosing strategies. Mol Pharmacol 2014;86:485-91
11. Taylor RP, Lindorfer MA. Fcg-receptor-mediated trogocytosis impacts mAb-based therapies: historical precedence and recent developments. Blood 2015;125: 762-6
12. Bleeker WK, Munk ME, Mackus WJ, et al. Estimation of dose requirements for sustained in vivo activity of a therapeutic human anti-CD20 antibody. Br J Haematol 2008;140:303-12
13. FDA approves new treatment for chronic lymphocytic Leukemia. Available from: www.fda.gov/Newsroom/ PressAnnouncements/ucm187966.htm [Last accessed 17 November 2009]
14. Osterborg A, Ronn BB, Jewell RC, et al. Correlation between serum ofatumumab concentrations, baseline patient characteristics and clinical outcomes in patients with fludarabine-refractory chronic lymphocytic leukemia (CLL) treated with single-agent ofatumumab. Blood 2009;114:3433
15. Coiffier B, Lepretre S, Pedersen LM, et al. Safety and efficacy of ofatumumab, a fully human monoclonal anti-CD20 antibody, in patients with relapsed or refractory B-cell chronic lymphocytic leukemia: a Phase I-II study. Blood 2008;111:1094-100
16. Wierda WG, Kipps TJ, Mayer J, et al. Hx-CD20-406 Study Investigators. Ofatumumab as single-agent CD20 immunotherapy in fludarabine-refractory chronic lymphocytic leukemia. J Clin Oncol 2010;28:1749-55
17. Wierda WG, Kipps TJ, Durig J, et al. Chemoimmunotherapy with O-FC in previously untreated patients with chronic lymphocytic leukemia. Blood 2011;117: 6450-8
18. Cortelezzi A, Sciumè M, Liberati AM, et al. Bendamustine in combination with ofatumumab in relapsed or refractory chronic lymphocytic leukemia: a GIMEMA Multicenter Phase II Trial. Leukemia 2014;28:642-8
19. Ferrajoli A, O'Brien S, Wiuerda W, et al. Combination therapy with ofatumumab and lenalidomide in patients with relapsed chronic lymphocytic leukemia (CLL): results of a Phase II Trial. Blood 2011;118:1788
20. Flinn IW, Harwin W, Macias-Perez IM, et al. A Phase II trial of ofatumumab for older patients and patients who refuse fludarabine-based regimens with previously untreated chronic lymphocytic leukemia or small lymphocytic leukemia Blood. 2011;118:3912
21. Castro JE, Choi MY, Carvajal T, et al. Ofatumumab and high-dose methylprednisolone for the treatment of patients with relapsed or refractory chronic lymphocytic leukemia. Blood Cancer J 2014;4:e258
22. Doubek M, Brychtova Y, Panovska A, et al. Ofatumumab added to dexamethasone in patients with relapsed or refractory chronic lymphocytic leukemia: results from a phase II study. Am J Hematol 2015. [Epub ahead of print]
23. Hillmen P, Robak T, Janssens A, et al. Ofatumumab + chlorambucil versus chlorambucil alone in patients with untreated chronic lymphocytic leukemia (CLL): results of the phase iii study complement 1 (OMB110911). Blood 2013;122:528
24. Tausch E, Beck P, Schlenk RF, et al. NOTCH1 mutation and treatment outcome in CLL patients treated with chlorambucil (Chl) or ofatumumab-chl (OChl): results from the phase iii study complement 1 (OMB110911). Blood 2013;122:527
25. Tausch E, Galler C, Richard Schlenk R, et al. Gene mutations and treatment outcome in CLL patients treated with chlorambucil (Chl) or ofatumumab-Chl (OChl): results from the phase III study complement 1 (OMB110911). Blood 2014;124:1992
26. Osterborg A, Udwardy M, Zaritskey A, et al. Ofatumumab (OFA) vs. Physician's choice (PC) of therapy in patients (pts) with bulky fludarabine refractory (BFR) chronic lymphocytic leukaemia (CLL): results of the phase III study OMB114242. Blood 2014;12:4684
27. Byrd JC, Brown JR, O'Brien S, et al. Ibrutinib versus ofatumumab in previously treated chronic lymphoid leukemia. N Engl J Med 2014;371:213-322
28. van Oers M, Kuliczkowski K, Smolej L, et al. Ofatumumab (OFA) maintenance prolongs PFS in relapsed CLL: Prolong study interim analysis results. Blood 2014;124:21
29. Cirillo M, Venturini M, Ciccarelli L, et al. Clinician versus nurse symptom reporting using the national cancer institute-common terminology criteria for adverse events during chemotherapy: results of a comparison based on patient's self-reported questionnaire. Ann Oncol 2009;20:1929-35
30. Tam CS, O'Brien S, Lerner S, et al. The natural history of fludarabine-refractory chronic lymphocytic leukemia patients who fail alemtuzumab or have bulky lymphadenopathy. Leuk Lymphoma 2007;48:1931-9
31. European Medicines Agency Arzerra summary of opinion (initial authorisation) [online]. Available from: www.emea.europa. eu/pdfs/human/opinion/Arzerra-214261en. pdf [Last accessed 25 January 2010]