Inotuzumab ozogamicin in B-cell acute lymphoblastic leukemias and non-Hodgkin's lymphomas

Expert Opinion on Biological Therapy

Volumn 15, Issue 4, 2015, Pages 601-611

  Ohanian, Maro ^a   Kantarjian, Hagop ^a   Guy, Daniel ^a   Thomas, Deborah ^a   Jabbour, Elias ^a   O'brien, Susan ^a  

^a UNIVERSITY OF TEXAS   (United States)

Author keywords

Acute lymphoblastic leukemia; Inotuzumab ozogamicin; Non Hodgkin lymphoma

Indexed keywords

INOTUZUMAB OZOGAMICIN; CD22 ANTIGEN; MONOCLONAL ANTIBODY;

ACUTE LYMPHOBLASTIC LEUKEMIA; ANTINEOPLASTIC ACTIVITY; ARTICLE; B CELL LEUKEMIA; CANCER COMBINATION CHEMOTHERAPY; CANCER PATIENT; CANCER RESISTANCE; HUMAN; LEUKEMIA RELAPSE; NONHODGKIN LYMPHOMA; PHASE 1 CLINICAL TRIAL (TOPIC); PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); RANDOMIZED CONTROLLED TRIAL (TOPIC); ACUTE DISEASE; ANIMAL; ANTAGONISTS AND INHIBITORS; B LYMPHOCYTE; BIOSYNTHESIS; DRUG EFFECTS; IMMUNOLOGY; LEUKEMIA, B-CELL; LYMPHOMA, NON-HODGKIN; METABOLISM;

ACUTE DISEASE; ANIMALS; ANTIBODIES, MONOCLONAL; ANTIBODIES, MONOCLONAL, HUMANIZED; B-LYMPHOCYTES; HUMANS; LEUKEMIA, B-CELL; LYMPHOMA, NON-HODGKIN; SIALIC ACID BINDING IG-LIKE LECTIN 2;

EID: 84925259518     PISSN: 14712598     EISSN: 17447682     Source Type: Journal    
DOI: 10.1517/14712598.2015.1024652     Document Type: Article

References (70)

1. Stoll BJ, Hansen NI, Bell EF, et al. Neonatal outcomes of extremely preterm infants from the NICHD Neonatal Research Network 3. Pediatrics 2010;126:443-56
2. Shah PS, Kaufman DA. Antistaphylococcal immunoglobulins to prevent staphylococcal infection in very low birth weight infants. Cochrane Database Syst Rev 2009(2):CD006449
3. Benjamin DK, Schelonka R, White R, et al. A blinded, randomized, multicenter study of an intravenous Staphylococcus aureus immune globulin. J Perinatol 2006;26:290-5
4. DeJonge M, Burchfield D, Bloom B, et al. Clinical trial of safety and efficacy of INH-A21 for the prevention of nosocomial staphylococcal bloodstream infection in premature infants 1. J Pediatr 2007;151:260-5
5. Fanaroff AA, Korones SB, Wright LL, et al. A controlled trial of intravenous immune globulin to reduce nosocomial infections in very-low-birth-weight infants. National institute of child health and human development neonatal research network. N Engl J Med 1994;330:1107-13
6. Weisman LE, Schuman RF, Lukomska E, et al. Effectiveness and pharmacokinetics of an anti-lipoteichoic acid humanized mouse chimeric monoclonal antibody [abstract]. Available from: http://www abstracts2view com/ pasall/ 2001
7. Weisman LE, Fischer GW, Thackray HM, et al. Safety and pharmacokinetics of a chimerized anti-lipoteichoic acid monoclonal antibody in healthy adults. Int Immunopharmacol 2009;9:639-44
8. Theilacker C, Kropec A, Hammer F, et al. Protection against Staphylococcus aureus by antibody to the polyglycerolphosphate backbone of heterologous lipoteichoic acid. J Infect Dis 2012;205:1076-85
9. Weisman LE. Coagulase-negative staphylococcal disease: emerging therapies for the neonatal and pediatric patient 2. Curr Opin Infect Dis 2004;17:237-41
10. Weisman LE, Thackray HM, Steinhorn RH, et al. A randomized study of a monoclonal antibody (pagibaximab) to prevent staphylococcal sepsis. Pediatrics 2011;128:271-9
11. Weisman LE, Thackray HM, Garcia-Prats JA, et al. Phase I/II doubleblind, placebo-controlled, dose escalation, safety, and pharmacokinetic study of pagibaximab BSYX-A110), an antistaphylococcal monoclonal antibody for the prevention of staphylococcal bloodstream infections, in very-low-birth-weight neonates. Antimicrob Agents Chemother 2009;53:2879-86
12. Biosynexus. Safety and efficacy of pagibaximab injection in very low birth weight neonates for prevention of staphylococcal sepsis. Available from: http://www clinicaltrials gov/ct2/show/ NCT00646399? term=Pagibaximab&rank=1 2011
13. Eibl MM, Wolf HM, Furnkranz H, et al. Prevention of necrotizing enterocolitis in low-birth-weight infants by IgA-IgG feeding. N Engl J Med 1988;319:1-7
14. Eibl MM, Wolf HM, Furnkranz H, et al. Prophylaxis of necrotizing enterocolitis by oral IgA-IgG: review of a clinical study in low birth weight infants and discussion of the pathogenic role of infection. J Clin Immunol 1990;10:72S-7S
15. Carr R. The role of colony stimulating factors and immunoglobulin in the prevention and treatment of neonatal infection. Arch Dis Child Fetal Neonatal Ed 2013;98:F192-4
16. Reichmann NT, Picarra CC, Monteiro JM, et al. Differential localization of LTA synthesis proteins and their interaction with the cell division machinery in Staphylococcus aureus. Mol Microbiol 2014;92:273-86
17. Power Coombs MR, Kronforst K, Levy O. Neonatal host defense against Staphylococcal infections. Clin Dev Immunol 2013;2013:826303
18. Manzoni P, Rinaldi M, Cattani S, et al. Bovine lactoferrin supplementation for prevention of late-onset sepsis in very low-birth-weight neonates: a randomized trial. JAMA 2009;302:1421-8
19. Brocklehurst P, Farrell B, King A, et al. Treatment of neonatal sepsis with intravenous immune globulin 2. N Engl J Med 2011;365:1201-11
20. Kantarjian H, Thomas D, O'Brien S, et al. Long-term follow-up results of hyperfractionated cyclophosphamide, vincristine, doxorubicin, and dexamethasone (Hyper-CVAD), a doseintensive regimen, in adult acute lymphocytic leukemia. Cancer 2004;101(12):2788-801
21. Fielding AK, Richards SM, Chopra R, et al. Outcome of 609 adults after relapse of acute lymphoblastic leukemia (ALL); an MRC UKALL12/ECOG 2993 study. Blood 2007;109(3):944-50
22. 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):90-8
23. Tedder TF, Poe JC, Haas KM. CD22: a multifunctional receptor that regulates B lymphocyte survival and signal transduction. Adv Immunol 2005;88:1-50
24. Polson AG, Williams M, Gray AM, et al. Anti-CD22-MCC-DM1: an antibody-drug conjugate with a stable linker for the treatment of non-Hodgkin's lymphoma. Leukemia 2010;24(9):1566-73
25. Chu YW, Polson A. Antibody-drug conjugates for the treatment of B-cell non-Hodgkin's lymphoma and leukemia. Future Oncol 2013;9(3):355-68
26. Leonard JP, Goldenberg DM. Preclinical and clinical evaluation of epratuzumab (anti-CD22 IgG) in B-cell malignancies. Oncogene 2007;26(25):3704-13
27. Piccaluga PP, Arpinati M, Candoni A, et al. Surface antigens analysis reveals significant expression of candidate targets for immunotherapy in adult acute lymphoid leukemia. Leuk Lymphoma 2011;52(2):325-7
28. Hoelzer D. Anti-CD22 therapy in acute lymphoblastic leukaemia. Lancet Oncol 2012;13(4):329-31
29. Kantarjian H, Thomas D, Jorgensen J, et al. Inotuzumab ozogamicin, an anti-CD22-calecheamicin conjugate, for refractory and relapsed acute lymphocytic leukaemia: a phase 2 study. Lancet Oncol 2012;13(4):403-11
30. Tedder TF, Tuscano J, Sato S, et al. CD22, a B lymphocyte-specific adhesion molecule that regulates antigen receptor signaling. Annu Rev Immunol 1997;15:481-504
31. Le Jeune C, Thomas X. Antibody-based therapies in B-cell lineage acute lymphoblastic leukaemia. Eur J Haematol 2015;94(2):99-108
32. Feld J, Barta SK, Schinke C, et al. Linked-in: design and efficacy of antibody drug conjugates in oncology. Oncotarget 2013;4(3):397-412
33. Strebhardt K, Ullrich A. Paul Ehrlich's magic bullet concept: 100 years of progress. Nat Rev Cancer 2008;8(6):473-80
34. Billadeau DD, Leibson PJ. ITAMs versus ITIMs: striking a balance during cell regulation. J Clin Invest 2002;109(2):161-8
35. DiJoseph JF, Armellino DC, Boghaert ER, et al. Antibody-targeted chemotherapy with CMC-544: a CD22-targeted immunoconjugate of calicheamicin for the treatment of B-lymphoid malignancies. Blood 2004;103(5):1807-14
36. Thorson JS, Sievers EL, Ahlert J, et al. Understanding and exploiting nature's chemical arsenal: the past, present and future of calicheamicin research. Curr Pharm Des 2000;6(18):1841-79
37. Litzow MR. Monoclonal antibody-based therapies in the treatment of acute lymphoblastic leukemia. Am Soc Clin Oncol Educ Book 2013;2013:294-9
38. Shan D, Press OW. Constitutive endocytosis and degradation of CD22 by human B cells. J Immunol 1995;154(9):4466-75
39. Carnahan J, Wang P, Kendall R, et al. Epratuzumab, a humanized monoclonal antibody targeting CD22: characterization of in vitro properties. Clin Cancer Res 2003;9(10 Pt 2):3982S-90S
40. Portell CA, Advani AS. Novel targeted therapies in acute lymphoblastic leukemia. Leuk Lymphoma 2014;55(4):737-48
41. de Vries JF, Zwaan CM, De Bie M, et al. The novel calicheamicin-conjugated CD22 antibody inotuzumab ozogamicin (CMC-544) effectively kills primary pediatric acute lymphoblastic leukemia cells. Leukemia 2012;26(2):255-64
42. DiJoseph JF, Goad ME, Dougher MM, et al. Potent and specific antitumor efficacy of CMC-544, a CD22-targeted immunoconjugate of calicheamicin, against systemically disseminated B-cell lymphoma. Clin Cancer Res 2004;10(24):8620-9
43. Takeshita A, Shinjo K, Yamakage N, et al. CMC-544 (inotuzumab ozogamicin) shows less effect on multidrug resistant cells: analyses in cell lines and cells from patients with B-cell chronic lymphocytic leukaemia and lymphoma. Br J Haematol 2009;146(1):34-43
44. Takeshita A, Yamakage N, Shinjo K, et al. CMC-544 (inotuzumab ozogamicin), an anti-CD22 immunoconjugate of calicheamicin, alters the levels of target molecules of malignant B-cells. Leukemia 2009;23(7):1329-36
45. DiJoseph JF, Dougher MM, Kalyandrug LB, et al. Antitumor efficacy of a combination of CMC-544 (inotuzumab ozogamicin), a CD22-targeted cytotoxic immunoconjugate of calicheamicin, and rituximab against non-Hodgkin's B-cell lymphoma. Clin Cancer Res 2006;12(1):242-9
46. Golay J, Lazzari M, Facchinetti V, et al. CD20 levels determine the in vitro susceptibility to rituximab and complement of B-cell chronic lymphocytic leukemia: further regulation by CD55 and CD59. Blood 2001;98(12):3383-9
47. DiJoseph JF, Dougher MM, Evans DY, et al. Preclinical anti-tumor activity of antibody-targeted chemotherapy with CMC-544 (inotuzumab ozogamicin), a CD22-specific immunoconjugate of calicheamicin, compared with nontargeted combination chemotherapy with CVP or CHOP. Cancer Chemother Pharmacol 2011;67(4):741-9
48. Kantarjian H, Thomas D, Jorgensen J, et al. Results of inotuzumab ozogamicin, a CD22 monoclonal antibody, in refractory and relapsed acute lymphocytic leukemia. Cancer 2013;119(15):2728-36
49. Kebriaei P, Wilhelm K, Ravandi F, et al. Feasibility of allografting in patients with advanced acute lymphoblastic leukemia after salvage therapy with inotuzumab ozogamicin. Clin Lymphoma Myeloma Leuk 2013;13(3):296-301
50. Rytting M, Triche L, Thomas D, et al. Initial experience with CMC-544 (inotuzumab ozogamicin) in pediatric patients with relapsed B-cell acute lymphoblastic leukemia. Pediatr Blood Cancer 2014;61(2):369-72
51. Advani A, Coiffier B, Czuczman MS, et al. Safety, pharmacokinetics, and preliminary clinical activity of inotuzumab ozogamicin, a novel immunoconjugate for the treatment of B-cell non-Hodgkin's lymphoma: results of a Phase I study. J Clin Oncol 2010;28(12):2085-93
52. Advani AS. New immune strategies for the treatment of acute lymphoblastic leukemia: antibodies and chimeric antigen receptors. Hematology Am Soc Hematol Educ Program 2013;2013:131-7
53. Kebriaei P. Personal Communication with Dr. Kebraiaei. 2014
54. DeAngelo D, Shustov A, Liedtke M, et al. Weekly Inotuzumab Ozogamicin (InO) in adult patients with relapsed or refractory CD22-positive Acute Lymphoblastic Leukemia (ALL). Blood 2013. Available from: http://bloodjournal.hematologylibrary.org/content/122/21/3906 [Last accessed 19 March 2014]
55. Bassan R, Hoelzer D. Modern therapy of acute lymphoblastic leukemia. J Clin Oncol 2011;29(5):532-43
56. Faderl S, O'Brien S, Pui CH, et al. Adult acute lymphoblastic leukemia: concepts and strategies. Cancer 2010;116(5):1165-76
57. Gokbuget N, Hoelzer D. Treatment of adult acute lymphoblastic leukemia. Semin Hematol 2009;46(1):64-75
58. Rousselot P, Cayuela JM, Hayette S. Dasatinib (Sprycel®) and low intensity chemotherapy for first-line treatment in elderly patients with de novo Philadelphia positive ALL (EWALL-PH-01): kinetic of response, resistance and prognostic significance [abstract]. Blood (ASH Annual Meeting Abstracts) 2010. 116:Abstract 172. Available from: http://abstracts.hematologylibrary.org/cgi/ content/abstract/116/21/172 [Last accessed 9 July 2014]
59. Jain N, O'Brien S, Thomas D, et al. Inotuzumab ozogamicin in combination with low-intensity chemotherapy (Mini-hyper-CVD) as frontline therapy for older patients (≥ 60 years) with acute lymphoblastic leukemia (ALL). Blood 2013. Available from: http://bloodjournal.hematologylibrary.org/content/122/21/1432.abstract [Last accessed 3 October 2014]
60. Jabbour E, O'Briens S, Thomas D, et al. Inotuzumab Ozogamicin in Combination with Low-Intensity Chemotherapy (mini-hyper-CVD) As Frontline Therapy for Older Patients (≥ 60 years) with Acute Lymphoblastic Leukemia (ALL). 2014. Available from: https://ash.confex.com/ash/2014/webprogram/Paper70208.html [Last accessed 19 November 2014]
61. A study of inotuzumab ozogamicin versus investigator's choice of chemotherapy in patients with relapsed or refractory acute lymphoblastic leukemia. Available from: http://clinicaltrials.gov/show/NCT01564784ClinicalTrials.govIdentifier:NCT01564784 [Last accessed 16 September 2013]
62. B1931022: an open-label, randomized Phase III study of inotuzumab ozogamicin compared to a defined investigator's choice in adult patients with relapsed or refractory cd22-positive Acute Lymphoblastic Leukemia (ALL). Available from: http://www.utsouthwestern.edu/research/fact/detail.html?studyid=STU%20092012-062 [Last accessed 16 September 2013]
63. Ogura M, Tobinai K, Hatake K, et al. Phase I study of inotuzumab ozogamicin (CMC-544) in Japanese patients with follicular lymphoma pretreated with rituximab-based therapy. Cancer Sci 2010;101(8):1840-5
64. Goy A, Leach J, WC E, et al. Inotuzumab ozogamicin (CMC-544) in patients with indolent B-cell NHL that is refractory to rituximab alone, rituximab and chemotherapy, or radioimmunotherapy: preliminary safety and efficacy from a Phase II trial. Program and Abstracts of the 52nd American Society of Hematology Annual Meeting and Exposition. Orlando, FL, USA, 6 December 2010. Available from: https://ash.confex.com/ash/2010/webprogram/Paper33626.html [Last accessed 3 May 2014]
65. Ogura M, Hatake K, Ando K, et al. Phase I study of anti-CD22 immunoconjugate inotuzumab ozogamicin plus rituximab in relapsed/refractory B-cell non-Hodgkin lymphoma. Cancer Sci 2012;103(5):933-8
66. Fayad L, Offner F, Smith MR, et al. Safety and clinical activity of a combination therapy comprising two antibody-based targeting agents for the treatment of non-Hodgkin lymphoma: results of a phase I/II study evaluating the immunoconjugate inotuzumab ozogamicin with rituximab. J Clin Oncol 2013;31(5):573-83
67. Ogura M, Uchida K, MacDonald D, et al. An open-label, Phase I study of R-CVP in combination with inotuzumab ozogamicin in patients with relapsed/ refractory CD22-positive B-cell nonhodgkin lymphoma. Session: 624. Lymphoma - Therapy with Biologic Agents, excluding Pre-Clinical Models: Poster III 2011. Available from: https://ash.confex.com/ash/2011/webprogram/Paper43562.html
68. Sangha R, Davies A, Dang NH, et al. Phase I Study Of Inotuzumab Ozogamicin (InO) Combined With R-GDP For Relapsed/Refractory CD22+ B-Cell Non-Hodgkin Lymphoma (B-NHL). 2013. Available from: http://bloodjournal.hematologylibrary.org/content/122/21/1821 [Last accessed 13 October 2014]
69. Dang NH, Ogura M, Castaigne S, et al. Randomized, Phase III trial of inotuzumab ozogamicin plus rituximab (R-InO) versus chemotherapy for relapsed/refractory aggressive B-cell non-Hodgkin lymphoma (B-NHL). J Clin Oncol 2014.32 (suppl; abstract 8529):5s. Available from: http://meetinglibrary.asco.org/content/129147-144 [Last accessed 13 October 2014]
70. Obrien S TD, Jorgensen JL, et al. Experience with 2 dose schedules of inotuzumab ozogamicin, single dose, and weekly, in refractory-relapsed acute lymphocytic leukemia (ALL) [abstract]. Blood 2012;120(21):671