Potential for bispecific T-cell engagers: Role of blinatumomab in acute lymphoblastic leukemia

Drug Design, Development and Therapy

Volumn 10, Issue , 2016, Pages 757-765

  Le Jeune, Caroline ^a   Thomas, Xavier ^a  

^a CENTRE HOSPITALIER LYON SUD   (France)

Author keywords

B cell lineage acute lymphoblastic leukemia; BiTE monoclonal antibodies; Blinatumomab; Minimal residual disease; Relapsed refractory

Indexed keywords

AMINOTRANSFERASE; BLINATUMOMAB; CD19 ANTIGEN; CD3 ANTIGEN; DEXAMETHASONE; GAMMA GLUTAMYLTRANSFERASE; PREDNISONE; VINCRISTINE; ANTINEOPLASTIC AGENT; BISPECIFIC ANTIBODY;

ACUTE LYMPHOBLASTIC LEUKEMIA; AMINOTRANSFERASE BLOOD LEVEL; ANTIBODY COMBINING SITE; ANTIBODY SPECIFICITY; ANTIGEN BINDING; ANTINEOPLASTIC ACTIVITY; APHASIA; APOPTOSIS; B LYMPHOCYTE; BRAIN DISEASE; CANCER INCIDENCE; CELL SPECIFICITY; CHILL; DIARRHEA; DISORIENTATION; DRUG EFFICACY; DRUG EXCRETION; DRUG HALF LIFE; DRUG MECHANISM; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; FATIGUE; FEVER; GAMMA GLUTAMYL TRANSFERASE BLOOD LEVEL; HEADACHE; HUMAN; IMMUNOGLOBULIN DEFICIENCY; LEUKOPENIA; LYMPHOCYTE PROLIFERATION; LYMPHOCYTOPENIA; NAUSEA; NEUTROPENIA; OUTCOME ASSESSMENT; PERIPHERAL EDEMA; PHASE 1 CLINICAL TRIAL (TOPIC); PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); PREVALENCE; REVIEW; SEIZURE; SIDE EFFECT; T LYMPHOCYTE ACTIVATION; THROMBOCYTOPENIA; TREMOR; VOLUME OF DISTRIBUTION; VOMITING; CELL PROLIFERATION; DRUG EFFECTS; IMMUNOLOGY; PATHOLOGY; PRECURSOR CELL LYMPHOBLASTIC LEUKEMIA-LYMPHOMA; T LYMPHOCYTE;

ANTIBODIES, BISPECIFIC; ANTIGENS, CD19; ANTIGENS, CD3; ANTINEOPLASTIC AGENTS; APOPTOSIS; CELL PROLIFERATION; HUMANS; PRECURSOR CELL LYMPHOBLASTIC LEUKEMIA-LYMPHOMA; T-LYMPHOCYTES;

EID: 84959468203     PISSN: None     EISSN: 11778881     Source Type: Journal    
DOI: 10.2147/DDDT.S83848     Document Type: Review

References (60)

1. Siegel RL, Miller KD, Jemal A. Cancer statistics, 2015. CA Cancer J Clin. 2015;65(1):5–29.
2. SEER Cancer Statistics Review [webpage on the Internet]. Previous Version: SEER Cancer Statistics Review, 1975–2010. 2015. Available from: http://seer.cancer.gov/archive/csr/1975_2010/. Accessed October 4, 2015.
3. Hunger SP, Lu X, Devidas M, et al. Improved survival for children and adolescents with acute lymphoblastic leukemia between 1990 and 2005: a report from the children’s oncology group. J Clin Oncol. 2012; 30(14):1663–1669.
4. Stock W, Johnson JL, Stone RM, et al. Dose intensification of daunorubicin and cytarabine during treatment of adult acute lymphoblastic leukemia: results of Cancer and Leukemia Group B Study 19802. Cancer. 2013;119(1):90–98.
5. Thomas DA, O’Brien S, Faderl S, et al. Chemoimmunotherapy with a modified hyper-CVAD and rituximab regimen improves outcome in de novo Philadelphia chromosome-negative precursor B-lineage acute lymphoblastic leukemia. J Clin Oncol. 2010;28(24):3880–3889.
6. Stiller CA, Chessells JM, Fitchett M. Neurofibromatosis and childhood leukaemia/lymphoma: a population-based UKCCSG study. Br J Cancer. 1994;70(5):969–972.
7. Strevens MJ, Lilleyman JS, Williams RB. Shwachman’s syndrome and acute lymphoblastic leukaemia. Br Med J. 1978;2(6129):18.
8. Passarge E. Bloom’s syndrome: the German experience. Ann Genet. 1991;34(3–4):179–197.
9. Taylor AM, Metcalfe JA, Thick J, Mak YF. Leukemia and lymphoma in ataxia telangiectasia. Blood. 1996;87(2):423–438.
10. De Jonge R, Tissing WJE, Hooijberg JH, et al. Polymorphisms in folate-related genes and risk of pediatric acute lymphoblastic leukemia. Blood. 2009;113(10):2284–2289.
11. Preston DL, Kusumi S, Tomonaga M, et al. Cancer incidence in atomic bomb survivors. Part III. Leukemia, lymphoma and multiple myeloma, 1950–1987. Radiat Res. 1994;137(2 suppl):S68–S97. Erratum in: Radiat Res. 1994;139(1):129.
12. Greaves M. Infection, immune responses and the aetiology of childhood leukaemia. Nat Rev Cancer. 2006;6(3):193–203.
13. Campo E, Swerdlow SH, Harris NL, Pileri S, Stein H, Jaffe ES. The 2008 WHO classification of lymphoid neoplasms and beyond: evolving concepts and practical applications. Blood. 2011;117(19):5019–5032.
14. Hoelzer D, Thiel E, Löffler H, et al. Prognostic factors in a multicenter study for treatment of acute lymphoblastic leukemia in adults. Blood. 1988;71(1):123–131.
15. Wetzler M, Dodge RK, Mrózek K, et al. Prospective karyotype analysis in adult acute lymphoblastic leukemia: the cancer and leukemia Group B experience. Blood. 1999;93(11):3983–3993.
16. Hoelzer D. Personalized medicine in adult acute lymphoblastic leukemia. Haematologica. 2015;100(7):855–858.
17. Campana D. Minimal residual disease in acute lymphoblastic leukemia. Hematol Hematology Am Soc Hematol Educ Program. 2010;2010:7–12.
18. Bassan R, Spinelli O, Oldani E, et al. Improved risk classification for risk-specific therapy based on the molecular study of minimal residual disease (MRD) in adult acute lymphoblastic leukemia (ALL). Blood. 2009;113(18):4153–4162.
19. Larson RA, Dodge RK, Burns CP, et al. A five-drug remission induction regimen with intensive consolidation for adults with acute lymphoblastic leukemia: cancer and leukemia group B study 8811. Blood. 1995;85(8):2025–2037.
20. Linker CA, Levitt LJ, O’Donnell M, Forman SJ, Ries CA. Treatment of adult acute lymphoblastic leukemia with intensive cyclical chemotherapy: a follow-up report. Blood. 1991;78(11):2814–2822.
21. Kantarjian H, Thomas D, O’Brien S, et al. Long-term follow-up results of hyperfractionated cyclophosphamide, vincristine, doxorubicin, and dexamethasone (Hyper-CVAD), a dose-intensive regimen, in adult acute lymphocytic leukemia. Cancer. 2004;101(12):2788–2801.
22. Sive JI, Buck G, Fielding A, et al. Outcomes in older adults with acute lymphoblastic leukaemia (ALL): results from the international MRC UKALL XII/ECOG2993 trial. Br J Haematol. 2012;157(4):463–471.
23. Huguet F, Leguay T, Raffoux E, et al. Pediatric-inspired therapy in adults with Philadelphia chromosome-negative acute lymphoblastic leukemia: the GRAALL-2003 study. J Clin Oncol. 2009;27(6):911–918.
24. Bleyer WA, Poplack DG. Prophylaxis and treatment of leukemia in the central nervous system and other sanctuaries. Semin Oncol. 1985;12(2): 131–148.
25. Cortes J, O’Brien SM, Pierce S, Keating MJ, Freireich EJ, Kantarjian HM. The value of high-dose systemic chemotherapy and intrathecal therapy for central nervous system prophylaxis in different risk groups of adult acute lymphoblastic leukemia. Blood. 1995;86(6):2091–2097.
26. Gökbuget N, Kneba M, Raff T, et al; German Multicenter Study Group for Adult Acute Lymphoblastic Leukemia. Adult patients with acute lymphoblastic leukemia and molecular failure display a poor prognosis and are candidates for stem cell transplantation and targeted therapies. Blood. 2012;120(9):1868–1876.
27. Litzow MR. Finally moving forward in adult ALL. Blood. 2015;125(16):2453–2454.
28. Gupta V, Richards S, Rowe J. Acute Leukemia Stem Cell Transplantation Trialists’ Collaborative Group. Allogeneic, but not autologous, hematopoietic cell transplantation improves survival only among younger adults with acute lymphoblastic leukemia in first remission: an individual patient data meta-analysis. Blood. 2013;121(2):339–350.
29. Fielding AK, Richards SM, Chopra R, et al; Medical Research Council of the United Kingdom Adult ALL Working Party; Eastern Cooperative Oncology Group. Outcome of 609 adults after relapse of acute lymphoblastic leukemia (ALL); an MRC UKALL12/ECOG 2993 study. Blood. 2007;109(3):944–950.
30. Gökbuget N, Stanze D, Beck J, et al; German Multicenter Study Group for Adult Acute Lymphoblastic Leukemia. Outcome of relapsed adult lymphoblastic leukemia depends on response to salvage chemotherapy, prognostic factors, and performance of stem cell transplantation. Blood. 2012;120:2032–2041.
31. Tavernier E, Boiron JM, Huguet F, et al; GET-LALA Group; Swiss Group for Clinical Cancer Research SAKK; Australasian Leukaemia and Lymphoma Group. Outcome of treatment after first relapse in adults with acute lymphoblastic leukemia initially treated by the LALA-94 trial. Leukemia. 2007;21:1907–1914.
32. Kantarjian H, Gandhi V, Cortes J, et al. Phase 2 clinical and pharmacologic study of clofarabine in patients with refractory or relapsed acute leukemia. Blood. 2003;102(7):2379–2386.
33. Abbi KKS, Rybka W, Ehmann WC, Claxton DF. Phase I/II study of clofarabine, etoposide, and mitoxantrone in patients with refractory or relapsed acute leukemia. Clin Lymphoma Myeloma Leuk. 2015;15(1): 41–46.
34. Le Jeune C, Thomas X. Antibody-based therapies in B-cell lineage acute lymphoblastic leukaemia. Eur J Haematol. 2015;94:99–108.
35. Grupp SA, Kalos M, Barrett D, et al. Chimeric antigen receptor-modified T cells for acute lymphoid leukemia. N Engl J Med. 2013;368(16):1509–1518.
36. Kantarjian H, Thomas D, Wayne AS, O’Brien S. Monoclonal antibody-based therapies: a new dawn in the treatment of acute lymphoblastic leukemia. J Clin Oncol. 2012;30(31):3876–3883.
37. Ai J, Advani A. Current status of antibody therapy in ALL. Br J Haematol. 2015;168(4):471–480.
38. Raponi S, De Propris MS, Intoppa S, et al. Flow cytometric study of potential target antigens (CD19, CD20, CD22, CD33) for antibody-based immunotherapy in acute lymphoblastic leukemia: analysis of 552 cases. Leuk Lymphoma. 2011;52(6):1098–1107.
39. Fujimoto M, Poe JC, Inaoki M, Tedder TF. CD19 regulates B lymphocyte responses to transmembrane signals. Semin Immunol. 1998;10(4): 267–277.
40. Baracho GV, Miletic AV, Omori SA, Cato MH, Rickert RC. Emergence of the PI3-kinase pathway as a central modulator of normal and aberrant B cell differentiation. Curr Opin Immunol. 2011;23(2):178–183.
41. Dreier T, Lorenczewski G, Brandl C, et al. Extremely potent, rapid and costimulation-independent cytotoxic T-cell response against lymphoma cells catalyzed by a single-chain bispecific antibody. Int J Cancer. 2002; 100(6):690–697.
42. Nagorsen D, Kufer P, Baeuerle PA, Bargou R. Blinatumomab: a historical perspective. Pharmacol Ther. 2012;136(3):334–342.
43. Nagorsen D, Baeuerle PA. Immunomodulatory therapy of cancer with T cell-engaging BiTE antibody blinatumomab. Exp Cell Res. 2011; 317(9):1255–1260.
44. Offner S, Hofmeister R, Romaniuk A, Kufer P, Baeuerle PA. Induction of regular cytolytic T cell synapses by bispecific single-chain antibody constructs on MHC class I-negative tumor cells. Mol Immunol. 2006; 43(6):763–771.
45. ® (blinatumomab). Available from: http://pi.amgen.com/united_states/blincyto/blincyto_pi_hcp_english.pdf. Accessed October 11, 2015.
46. Wu B, Hijazi Y, Wolf A, Brandl C, Sun YN, Zhu M. Pharmacokinetics (PK) of blinatumomab and its clinical implications. J Clin Oncol. 2013; 31(15):abstract 3048.
47. Kaplan JB, Grischenko M, Giles FJ. Blinatumomab for the treatment of acute lymphoblastic leukemia. Invest New Drugs. 2015;33(6):1271–1279.
48. Bargou R, Leo E, Zugmaier G, et al. Tumor regression in cancer patients by very low doses of a T cell-engaging antibody. Science. 2008;321(5891):974–977.
49. Klinger M, Brandl C, Zugmaier G, et al. Immunopharmacologic response of patients with B-lineage acute lymphoblastic leukemia to continuous infusion of T cell-engaging CD19/CD3-bispecific BiTE antibody blinatumomab. Blood. 2012;119(26):6226–6233.
50. Topp MS, Kufer P, Gökbuget N, et al. Targeted therapy with the T-cell-engaging antibody blinatumomab of chemotherapy-refractory minimal residual disease in B-lineage acute lymphoblastic leukemia patients results in high response rate and prolonged leukemia-free survival. J Clin Oncol. 2011;29(18):2493–2498.
51. Topp MS, Gökbuget N, Zugmaier G, et al. Long-term follow-up of hematologic relapse-free survival in a phase 2 study of blinatumomab in patients with MRD in B-lineage ALL. Blood. 2012;120(26):5185–5187.
52. ®) antibody construct, in patients with minimal residual disease B-precursor acute lymphoblastic leukemia (ALL). Poster presented at: American Society of Hematology (ASH) Annual Meeting; December 6–9, 2014; San Franscisco, CA. Abstract 379.
53. Topp MS, Gökbuget N, Zugmaier G, et al. Phase II trial of the anti-CD19 bispecific T cell-engager blinatumomab shows hematologic and molecular remissions in patients with relapsed or refractory B-precursor acute lymphoblastic leukemia. J Clin Oncol. 2014;32(36):4134–4140.
54. Topp MS, Gökbuget N, Stein AS, et al. Safety and activity of blinatumomab for adult patients with relapsed or refractory B-precursor acute lymphoblastic leukaemia: a multicentre, single-arm, phase 2 study. Lancet Oncol. 2015;16(1):57–66.
55. Schlegel P, Lang P, Zugmaier G, et al. Pediatric posttransplant relapsed/refractory B-precursor acute lymphoblastic leukemia shows durable remission by therapy with the T-cell engaging bispecific antibody blinatumomab. Haematologica. 2014;99(7):1212–1219.
56. Ribera J-M, Ferrer A, Ribera J, Genescà E. Profile of blinatumomab and its potential in the treatment of relapsed/refractory acute lymphoblastic leukemia. Onco Targets Ther. 2015;8:1567–1574.
57. Barrett DM, Teachey DT, Grupp SA. Toxicity management for patients receiving novel T-cell engaging therapies. Curr Opin Pediatr. 2014; 26(1):43–49.
58. Teachey DT, Rheingold SR, Maude SL, et al. Cytokine release syndrome after blinatumomab treatment related to abnormal macrophage activation and ameliorated with cytokine-directed therapy. Blood. 2013;121(26):5154–5157.
59. Martinelli G, Dombret H, Chevallier P, et al. Complete molecular and hematologic response in adult patients with relapsed/refractory (R/R) Philadelphia chromosome-positive B-precursor acute lymphoblastic leukemia (ALL) following treatment with blinatumomab: results from a phase 2 single-arm, multicenter study (ALCANTARA). Blood. 2015;126(issue 23):abstract 679.
60. Maude SL, Frey N, Shaw PA, et al. Chimeric antigen receptor T cells for sustained remissions in leukemia. N Engl J Med. 2014;371(16):1507–1517.