Blinatumomab: A novel, bispecific, T-cell engaging antibody

American Journal of Health-System Pharmacy

Volumn 73, Issue 1, 2016, Pages e6-e13

  May, Megan Brafford ^a   Glode, Ashley ^b  

^a Baptist Health Lexington   (United States)

^b UNIVERSITY OF COLORADO   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ALANINE AMINOTRANSFERASE; BLINATUMOMAB; CD19 ANTIGEN; CD3 ANTIGEN; CLOFARABINE; T LYMPHOCYTE ANTIBODY; TUMOR ANTIGEN; VINCRISTINE SULFATE; ANTINEOPLASTIC AGENT; BISPECIFIC ANTIBODY;

ACUTE LYMPHOBLASTIC LEUKEMIA; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATION; ANEMIA; CANCER CHEMOTHERAPY; CONTINUOUS INFUSION; DIZZINESS; DRUG APPROVAL; DRUG COST; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; FEBRILE NEUTROPENIA; FEVER; HUMAN; HYPERGLYCEMIA; HYPERTRANSAMINASEMIA; HYPOKALEMIA; LEUKEMIA RELAPSE; LEUKOPENIA; MINIMAL RESIDUAL DISEASE; NEUTROPENIA; OVERALL SURVIVAL; PHASE 2 CLINICAL TRIAL (TOPIC); PHILADELPHIA CHROMOSOME NEGATIVE B LYMPHOBLASTIC LEUKEMIA; PHILADELPHIA CHROMOSOME NEGATIVE CELL; PNEUMONIA; PRE B LYMPHOCYTE; PRIORITY JOURNAL; REVIEW; THROMBOCYTOPENIA; TREMOR; ANIMAL; CLINICAL TRIAL (TOPIC); DRUG EFFECTS; IMMUNOLOGY; PHILADELPHIA 1 CHROMOSOME; PRECURSOR B-CELL LYMPHOBLASTIC LEUKEMIA-LYMPHOMA; PROCEDURES; T LYMPHOCYTE;

ANIMALS; ANTIBODIES, BISPECIFIC; ANTINEOPLASTIC AGENTS; CLINICAL TRIALS AS TOPIC; HUMANS; PHILADELPHIA CHROMOSOME; PRECURSOR B-CELL LYMPHOBLASTIC LEUKEMIA-LYMPHOMA; T-LYMPHOCYTES;

EID: 84961744416     PISSN: 10792082     EISSN: 15352900     Source Type: Journal    
DOI: 10.2146/ajhp150134     Document Type: Review

References (34)

1. American Cancer Society. Cancer facts and fgures, 2015. www.cancer.org/acs/groups/content/@editorial/documents/document/acspc-044552.pdf (accessed 2015 22 Feb).
2. Narayanan S, Shami PJ. Treatment of acute lymphoblastic leukemia in adults. Crit Rev Oncol Hematol. 2012;81:94-102.
3. Siegel R, Ma J, Zou Z, Jemal A. Cancer statistics, 2014. CA Cancer J Clin. 2014;64:9-29.
4. National Cancer Institute. SEER cancer statistics review, 1975-2011: overview, age distribution of incidence cases by site. Updated December 17, 2014. http://seer.cancer.gov/archive/csr/1975-2011 (accessed 2015 Oct. 1).
5. Esparza S, Sakamoto K. Topics in pediatric leukemia-acute lymphoblastic leukemia. MedGenMed. 2005;7:23.
6. Ma H, Sun H, Sun X. Survival improvements by a decade of patients aged 0-14 years with acute lymphoblastic leukemia: a SEER analysis. Sci Rep. 2014;4:4277.
7. Pui CH, Jeha S. New therapeutic strategies for the treatment of acute lymphoblastic leukaemia. Nat Rev Drug Discov. 2007;6:149-65.
8. Rowe JM, Buck G, Burnett AK et al. Induction therapy for adults with acute lymphoblastic leukemia: results of more than 1500 patients from the international ALL trial: MRC UKALL XII/ECOG E2993. Blood. 2005;106:3760-7.
9. McGregor S, McNeer J, Gurbuxani S. Beyond the 2008 World Health Organization classification: the role of the hematopathology laboratory in the diagnosis and management of acute lymphoblastic leukemia. Semin Diagn Pathol. 2012;29:2-11.
10. National Cancer Institute. Adult acute lymphoblastic leukemia treatment (PDQ). Updated January 13, 2015. www.cancer.gov/cancertopics/pdq/treatment/adultALL/HealthProfessional (accessed 2015 Feb. 22).
11. National Comprehensive Cancer Network. NCCN guidelines for patients: acute lymphoblastic leukemia. Version 2. 2014. http://www.nccn.org/patients/guidelines/all/files/assets/common/downloads/files/all.pdf (accessed 2015 Feb. 22).
12. Fielding A. The treatment of adults with acute lymphoblastic leukemia. Hematology. 2008;1:381-9.
13. Food and Drug Administration. Drug approvals: blinatumomab. www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm425597.htm (accessed 2015 Feb. 22).
14. 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;16:57-66.
15. Thomas X. Blinatumomab: a new era of treatment for adult ALL? Lancet Oncol. 2015;16:6-7.
16. Hoffman LM, Gore L. Blinatumomab, a bi-specific anti-CD19/CD3 BiTE antibody for thr treatment of acute lymphoblastic leukemia: perspectives and current pediatric applications. Front Oncol. 2014;4:article 63.
17. Hoelzer D, Gokbuget N. Chemoimmunotherapy in acute lymphoblastic leukemia. Blood Rev. 2012;26:25-32.
18. Topp MS, Kufer P, Gokbuget 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;29:2493-8.
19. 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;119:6226-33.
20. Von Stackelberg A, Zugmaier G, Handgretinger R et al. A phase 1/2 study of blinatumomab in pediatric patients with relapsed/refractory B-cell precursor acute lymphoblastic leukemia. https://ash.confex.com/ash/2013/webprogram/Paper59492.html (accessed 2015 Oct. 2).
21. National Cancer Institute. Common terminology criteria for adverse events (CTCAE). Updated 2009 May 28. http://evs.nci.nih.gov/ftp1/CTCAE/CTCAE-4.03-2010-06-14-QuickReference-5x7.pdf (accessed 2015 Oct. 28).
22. Blincyto (blinatumomab) prescribing information. Thousand Oaks, CA: Amgen; 2014.
23. Teachy 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;121:5154-7.
24. Maude SL, Barrett D, Teachy DT, Grupp SA. Managing cytokine release syndrome associated with novel T cell-engaging therapies. Cancer J. 2014;20:119-22.
25. Bargou R, Noppeney R, Schuler M et al. The BiTE MT103 (MEDI-538) induces clinical responses in heavily pre-treated NHL patients. Blood. 2006;108:693.
26. Chen C. Amgen leukemia therapy costs $178, 000, among priciest drugs (December 17, 2014). www.bloomberg.com/news/articles/2014-12-17/amgen-leukemiatreatment-to-cost-178-000-among-priciestdrugs (accessed 2015 Oct. 1).
27. Pierson R. Amgen's new leukemia drug to carry $178, 000 price tag (December 17, 2014). www.reuters.com/article/2014/12/17/us-amgen-cancerexclusive-idUSKBN0JV1YU20141217 (accessed 2015 Oct. 1).
28. Saito AM, Cutler C, Zahrieh D et al. Costs of allogeneic hematopoietic cell transplantation with high-dose regimens. Biol Blood Marrow Transplant. 2008;14:197-207.
29. Topp MS, Gökbuget N, Zugmaier G et al. Anti-CD19 BiTE blinatumomab induces high complete remission rate in adult patients with relapsed B-precursor ALL: updated results of an ongoing phase II trial. Blood. 2011;118:abstract 252.
30. Pigneux A, Sauvezia M, Vey N et al. Clofarabine combinations in adults with refractory/relapsed acute lymphoblastic leukemia (ALL): a GRALL report. Blood. 2011;118:abstract 2586.
31. O'Brien S, Schiller G, Lister J et al. High-dose vincristine sulfate liposome injection for advanced, relapsed, and refractory adult Philadelphia chromosomenegative acute lympoblastic leukemia. J Clin Oncol. 2013;31:676-83.
32. ClinicalTrials.gov. Combination Chemotherapy with or without Blinatumomab in Treating Patients with Newly Diagnosed BCR-ABL-Negative B Lineage ALL. https://clinicaltrials.gov/ct2/show/NCT02003222 (accessed 2015 Feb. 12).
33. ClinicalTrials.gov. Phase III Trial of Blinatumomab vs Investigator's Choice of Chemotherapy in Patients With Relapsed or Refractory ALL. https://clinicaltrials. gov/ct2/show/NCT02013167 (accessed 2015 Feb. 12.
34. ClinicalTrials.gov. Blinatumomab in Treating Younger Patients With Relapsed B-cell ALL. https://clinicaltrials.gov/ct2/show/NCT02101853 (accessed 2015 Feb. 12).