Brentuximab vedotin: A CD30-Directed antibody-cytotoxic drug conjugate

Pharmacotherapy

Volumn 33, Issue 1, 2013, Pages 93-104

  Newland, Ashley M ^a,b   Li, Jenny X ^c   Wasco, Lindsey E ^a,b   Aziz, May T ^a,b   Lowe, Denise K ^a,b  

^a VIRGINIA COMMONWEALTH UNIVERSITY   (United States)

^b VIRGINIA COMMONWEALTH UNIVERSITY SCHOOL OF MEDICINE   (United States)

^c CEDARS SINAI MEDICAL CENTER   (United States)

Author keywords

Anaplastic large cell lymphoma; Brentuximab vedotin; Hodgkin lymphoma; SGN 35

Indexed keywords

BLEOMYCIN; BRENTUXIMAB VEDOTIN; CORTICOSTEROID; CYTOCHROME P450 3A4; DACARBAZINE; DOXORUBICIN; KETOCONAZOLE; MIDAZOLAM; PLACEBO; RIFAMPICIN; VINBLASTINE;

ADULT; ANAPHYLAXIS; ANEMIA; ARTICLE; AUTOLOGOUS STEM CELL TRANSPLANTATION; CANCER SURVIVAL; CHILL; CONTROLLED STUDY; COUGHING; DEATH; DIARRHEA; DOUBLE BLIND PROCEDURE; DRUG ABSORPTION; DRUG BLOOD LEVEL; DRUG CONTRAINDICATION; DRUG DISTRIBUTION; DRUG DOSE ESCALATION; DRUG EFFICACY; DRUG HALF LIFE; DRUG MECHANISM; DRUG METABOLISM; DRUG POTENTIATION; DRUG SAFETY; DRUG STRUCTURE; DRUG WITHDRAWAL; FATIGUE; FEVER; FOOD AND DRUG ADMINISTRATION; GRAFT VERSUS HOST REACTION; HODGKIN DISEASE; HUMAN; LARGE CELL LYMPHOMA; MAJOR CLINICAL STUDY; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; NAUSEA; NEUTROPENIA; NONHODGKIN LYMPHOMA; OVERALL SURVIVAL; PERIPHERAL NEUROPATHY; PHASE 1 CLINICAL TRIAL; PHASE 2 CLINICAL TRIAL; PHASE 3 CLINICAL TRIAL; PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY; PRURITUS; RANDOMIZED CONTROLLED TRIAL; RASH; SENSORY NEUROPATHY; SIDE EFFECT; STEADY STATE; STEVENS JOHNSON SYNDROME; THROMBOCYTOPENIA; TREATMENT RESPONSE; TUMOR LYSIS SYNDROME; UNITED STATES;

ANIMALS; ANTIBODIES, MONOCLONAL, HUMANIZED; ANTIGENS, CD30; ANTINEOPLASTIC AGENTS; CLINICAL TRIALS AS TOPIC; CYTOTOXINS; HUMANS; IMMUNOCONJUGATES; IMMUNOTOXINS; MOLECULAR TARGETED THERAPY;

EID: 84875467346     PISSN: 02770008     EISSN: None     Source Type: Journal    
DOI: 10.1002/phar.1170     Document Type: Article

References (49)

1. National Comprehensive Cancer Network. NCCN clinical practice guidelines in oncology, hodgkin lymphoma (version 1.2012). Available from http://www.nccn.org/professionals/physician-gls/pdf/hodgkins.pdf. Accessed February 4, 2012.
2. National Comprehensive Cancer Network. NCCN clinical practice guidelines in oncology, non-Hodgkin's lymphomas (version 1.2012). Available from http://www.nccn.org/professionals/physician-gls/pdf/nhl.pdf. Accessed February 4, 2012.
3. Howlader N, Noone AM, Krapcho M, et al. Surveillance Epidemiology and End Results (SEER) cancer statistics review, 1975-2008. Bethesda, MD: National Cancer Institute; Available from http://seer.cancer.gov/csr/1975-2008/. Accessed February 12, 2012.
4. Hsu FY, Johnston PB, Burke KA, Zhao Y. The expression of CD30 in anaplastic large cell lymphoma is regulated by nucleophosmin- anaplastic lymphoma kinase-mediated JunB level in a cell type-specific manner. Cancer Res 2006;66:9002-8.
5. Savage KJ, Harris NL, Vose JM, et al. ALK- anaplastic large-cell lymphoma is clinically and immunophenotypically different from both ALK+ ALCL and peripheral T-cell lymphoma, not otherwise specified: report from the International Peripheral T-Cell Lymphoma Project. Blood 2008;111:5496-504.
6. National Cancer Institute. National Cancer Institute adult hodgkin lymphoma treatment (PDQ). Updated 23 Sept 2011. Available from http://www.cancer.gov/cancertopics/pdq/treatment/adulthodgkins/ HealthProfessional Accessed February 15, 2012.
7. Horning S, Fanale M, deVos S, et al. Defining a population of Hodgkin lymphoma patients for novel therapeutics: an international effort [abstract]. Ann Oncol 2008;19(suppl 4):iv120-1.
8. Sureda A, Constans M, Iriondo A, et al. Prognostic factors affecting long-term outcome after stem cell transplantation in Hodgkin's lymphoma after a first relapse. Ann Oncol 2005;16:625-33.
9. Jagannath S, Armitage JO, Dicke KA, et al. Prognostic factors for response and survival after high-dose cyclophosphamide, carmustine, and etoposide with autologous bone marrow transplantation for relapsed Hodgkin's disease. J Clin Oncol 1989;7:179-85.
10. Moskowitz A, Perales M, Kewalramani T, et al. Outcomes for patients who fail high dose chemoradiotherapy and autologous stem cell rescue for relapsed and primary refractory Hodgkin lymphoma. Br J Haematol 2009;146:158-63.
11. Little R, Wittes RE, Longo DL, Wilson WH. Vinblastine for recurrent Hodgkin's disease following autologous bone marrow transplant. J Clin Oncol 1998;16:584-8.
12. Devizzi L, Santoro A, Bonfante V, Viviani S, Balzarini L, Valagussa P, Bonadonna G. Vinorelbine: an active drug for the management of patients with heavily pretreated Hodgkin's disease. Ann Oncol 1994;5:817-20.
13. Venkatesh H, Di Bella N, Flynn TP, Vellak MJ, Boehm KA, Asmar L. Results of a phase II multicenter trial of single-agent gemcitabine in patients with relapsed or chemotherapy-refractory Hodgkin's lymphoma. Clin Lymphoma 2004;5:110-5.
14. Spencer A, Reed K, Arthur C. Pilot study of an outpatientbased approach for advanced lymphoma using vinorelbine, gemcitabine and filgrastim. Intern Med J 2007;37:760-6.
15. Younes A, Romaguera J, Hagemeister F, et al. A pilot study of rituximab in patients with recurrent, classic Hodgkin disease. Cancer 2003;98:310-4.
16. Oki Y, Pro B, Fayad LE, et al. Phase 2 study of gemcitabine in combination with rituximab in patients with recurrent or refractory Hodgkin lymphoma. Cancer 2008;112:831-6.
17. Sureda A, Engert A, Browett PJ, et al. Interim results for the phase II study of panobinostat (LBH589) in patients (Pts) with relapsed/refractory Hodgkin's lymphoma (HL) after autologous hematopoietic stem cell transplant (AHSCT). J Clin Onc 2010;28:15s.
18. Kewalramani T, Zelenetz AD, Teruya-Feldstein J, et al. Autologous transplantation for relapsed or primary refractory T-cell lymphoma. Br J Haematol 2006;134:202-7.
19. Ferreri A, Govi S, Pileri S, Savage K. Anaplastic large cell lymphoma, ALK-positive. Crit Rev Oncol Hematol 2012;83: 293-302.
20. Younes A, Gopal AK, Smith S, et al. Results of a pivitol phase II study of brentuximab vedotin for patients with relapsed or refractory Hodgkin's lymphoma. J Clin Oncol 2012;30: 2183-9.
21. Pro B, Advani R, Brice P, et al. Brentuximab vedotin (SGN- 35) in patients with relapsed or refractory systemic anaplastic large-cell lymphoma: results of a phase II study. J Clin Oncol 2012;30:2190-6.
22. Seattle Genetics, Inc. Adcetris (brentuximab vedotin) Product Information. Bothell, WA;2012.
23. U.S. Food and Drug Administration. News & events: FDA approves Adcetris to treat two types of lymphoma. 19 Aug 2011. Available from http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm268781.htm. Accessed February 4, 2012.
24. Schwab U, Stein H, Gerdes J, Lemke H, Kirchner H, Schaadt M, Diehl V. Production of monoclonal antibody specific for Hodgkin and Sternberg-Reed cells of Hodgkin's disease and a subset of normal lymphoid cells. Nature 1982;299:65-7.
25. Younes A. CD30-targeted antibody therapy. Curr Opin Oncol 2011;23:587-93.
26. Katz J, Janik JE, Younes A. Brentuximab Vedotin (SGN-35). Clin Cancer Res 2011;17:6428-36.
27. Teicher BA, Chari RVJ. Antibody conjugate therapeutics: challenges and potential. Clin Cancer Res 2011;17:6389-97.
28. Younes A, Bartlett NL, Leonard JP, Kennedy DA, Lynch CM, Sievers EL, Forero-Torres A. Brentuximab vedotin (SGN-35) for relapsed CD30-positive lymphomas. N Engl J Med 2010;363:1812-21.
29. Fanale MA, Forero-Torres A, Rosenblatt JD, et al. A phase I weekly dosing study of brentuximab in patients with relapsed/refractory CD30-positive hematologic malignancies. Clin Cancer Res 2012;18:248-55.
30. Chen RW, Gopal AK, Smith SE, et al. Long-term survival analysis of an ongoing phase 2 study of brentuximab vedotin in patients with relapsed or refractory Hodgkin lymphoma. Blood 2012;120:Abstract 3689.
31. Cheson BD, Pfistner B, Juweid ME, et al. Revised response criteria for malignant lymphoma. J Clin Oncol 2007;25:579- 86.
32. Pro B, Advani RH, Brice P, et al. Long-term remissions observed in an ongoing phase 2 study of brentuximab vedotin in patients with relapsed or refractory systemic anaplastic large cell lymphoma. Blood 2012;120:Abstract 2745.
33. ClinicalTrials.gov. A randomized, double-blind, placebo-controlled phase 3 study of SGN-35 and best supportive care (BSC) versus placebo and BSC in the treatment of patients at high risk of residual Hodgkin lymphoma following autologous stem cell transplant. Available from http://clinicaltrials.gov/ct2/ show/NCT01100502. Accessed February 26, 2012.
34. Younes A, Connors JM, Park SI, Hudner N, Ansell SM. Frontline therapy with brentuximab vedotin combined with ABVD or AVD in patients with newly diagnosed advanced stage Hodgkin lymphoma. Blood 2011;118:Abstract 955.
35. Ansell SM, Connors JM, Park SI, O'Meara MM, Younes A. Frontline therapy with brentuximab vedotin combined with ABVD or AVD in patients with newly diagnosed advanced stage Hodgkin lymphoma. Blood 2012;120:Abstract 798.
36. Takeda Pharmaceutical Co. Seattle Genetics and Millennium report data from phase I trial of ADCETRIS (brentuximab vedotin) in front-line Hodgkin lymphoma at American Society of Hematology annual meeting. Available from http://www.takeda.com/press/article-43996.html. Accessed January 13, 2012.
37. Chen R, Palmer JM, Thomas SH, et al. Brentuximab vedotin enables successful reduced-intensity allogeneic hematopoietic cell transplantation in patients with relapsed or refractory Hodgkin lymphoma. Blood 2012;119:6379-81.
38. Illidge T, Bouabdallah R, Chen RW, et al. Allogeneic transplant following brentuximab vedotin treatment in patients with relapsed or refractory CD30 + lymphomas. Blood 2011;118:Abstract 3091.
39. Gopal AK, Ramchandren R, O'Connor OA, et al. Safety and efficacy of brentuximab vedotin for Hodgkin lymphoma recurring after allogeneic stem cell transplant. Blood 2012;120:560- 8.
40. ClinicalTrials.gov. Available from http://clinicaltrials/gov/ct2/results? term=brentuximab. Accessed February 26, 2012.
41. Hasanali Z, Sharma K, Shimko S, et al. Epigenetic modulation of CD30 gene expression in alemtuzumab resistant T cell malignancy: rational and efficacy of brentuximab vedotin. Blood 2012;120:Abstract 2454.
42. Jacobsen ED, Advani RH, Oki Y, et al. A phase 2 study of brentuximab vedotin in patients with relapsed or refractory CD30-positive non-Hodgkin lymphomas: interim results. Blood 2012;120:Abstract 2746.
43. Mehta A, Reddy VVN, Borate U. Anti CD-30 antibody-drug conjugate brentuximab vedotin (Adcetris) may be a promising treatment option for systemic mastocytosis (SM). Blood 2012;120:Abstract 2857.
44. U.S. Food and Drug Administration. FDA drug safety communication: new boxed warning and contraindication for Adcetris (brentuximab vedotin). Available from http://www.fda.gov/Drugs/DrugSafety/ucm287668.htm. Accessed January 13, 2012.
45. ClinicalTrials.gov. Clinical Pharmacology Study of Brentuximab Vedotin (SGN-35). Available from http://clinicaltrials.gov/ct2/show/NCT01026415. Accessed March 8, 2012.
46. Forero-Torres A, Berryman RB, Advani RH. Prolonged treatment with brentuximab vedotin (SGN-35) in patients with relapsed or refractory Hodgkin lymphoma (HL) or systemic anaplastic large cell lymphoma (sALCL) [abstract]. 53rd American Society of Hematology annual meeting and exposition. 2011. Available from http://ash.confex.com/ash/2011/webprogram/Paper42148.html. Accessed February 18, 2012.
47. Merrill J. Seattle Genetics will test oncology pricing acceptance with Adcetris. FDC Reports The Pink Sheet. August 29, 2011.
48. SeaGen Secure. SeaGen Secure Patient Assistance Program. Available from http://www.seagensecure.com/Accessed February 13, 2012.
49. NeedyMeds. SeaGen Secure Patient Assistance Program. Available from http://www.needymeds.org/generic-list.taf?-function=name&name= brentuximab%20vedotin. Accessed February 13, 2012.