A phase 1 study of the bispecific anti-CD30/CD16A antibody construct AFM13 in patients with relapsed or refractory Hodgkin lymphoma

Blood

Volumn 125, Issue 26, 2015, Pages 4024-4031

  Rothe, Achim ^a   Sasse, Stephanie ^a   Topp, Max S ^b   Eichenauer, Dennis A ^a   Hummel, Horst ^b   Reiners, Katrin S ^a   Dietlein, Markus ^a   Kuhnert, Georg ^a   Kessler, Joerg ^a   Buerkle, Carolin ^a   Ravic, Miroslav ^c   Knackmuss, Stefan ^c   Marschner, Jens Peter ^c   Von Strandmann, Elke Pogge ^a   Borchmann, Peter ^a   Enger, Andreas ^a  

^a UNIVERSITY HOSPITAL OF COLOGNE   (Germany)

^b UNIVERSITY OF WÜRZBURG   (Germany)

^c Affimed GmbH   (Germany)

Author keywords

[No Author keywords available]

Indexed keywords

AFM 13; BIOLOGICAL MARKER; BISPECIFIC ANTIBODY; BRENTUXIMAB VEDOTIN; CD16 ANTIGEN; UNCLASSIFIED DRUG; CD30 ANTIGEN; FC RECEPTOR; FCGR3A PROTEIN, HUMAN;

ADULT; AGED; ANEMIA; ANTIGEN BINDING; ARTICLE; BRONCHITIS; CANCER RECURRENCE; CHILL; CLINICAL ARTICLE; DISEASE CONTROL; DRUG HALF LIFE; DRUG SAFETY; DRUG TOLERABILITY; FEMALE; FEVER; HEADACHE; HEMOLYTIC ANEMIA; HODGKIN DISEASE; HUMAN; HYPOALBUMINEMIA; IMMUNOTHERAPY; INFUSION RELATED REACTION; MALE; MULTICENTER STUDY; NATURAL KILLER CELL; NAUSEA; PHARMACODYNAMICS; PHASE 1 CLINICAL TRIAL; PNEUMONIA; PRIORITY JOURNAL; RASH; REMISSION; RHINOPHARYNGITIS; STAPHYLOCOCCUS INFECTION; T CELL LYMPHOMA; THROMBOCYTOPENIA; TREATMENT RESPONSE; VOMITING; CLINICAL TRIAL; DOSE RESPONSE; IMMUNOLOGY; MIDDLE AGED; PROCEDURES; RECURRENT DISEASE; YOUNG ADULT;

ADULT; AGED; ANTIBODIES, BISPECIFIC; ANTIGENS, CD30; DOSE-RESPONSE RELATIONSHIP, DRUG; FEMALE; HODGKIN DISEASE; HUMANS; IMMUNOTHERAPY; MALE; MIDDLE AGED; RECEPTORS, IGG; RECURRENCE; YOUNG ADULT;

EID: 84933505755     PISSN: 00064971     EISSN: 15280020     Source Type: Journal    
DOI: 10.1182/blood-2014-12-614636     Document Type: Article

References (36)

1. Borchmann P, Eichenauer DA, Engert A. State of the art in the treatment of Hodgkin lymphoma. Nat Rev Clin Oncol. 2012;9(8):450-459.
2. Diehl V, Franklin J, Pfreundschuh M, et al; German Hodgkin's Lymphoma Study Group. Standard and increased-dose BEACOPP chemotherapy compared with COPP-ABVD for advanced Hodgkin's disease. N Engl J Med. 2003;348(24):2386-2395.
3. Majhail NS, Weisdorf DJ, Defor TE, et al. Long-term results of autologous stem cell transplantation for primary refractory or relapsed Hodgkin's lymphoma. Biol Blood Marrow Transplant. 2006;12(10):1065-1072.
4. Josting A, Müller H, Borchmann P, et al. Dose intensity of chemotherapy in patients with relapsed Hodgkin's lymphoma. J Clin Oncol. 2010;28(34):5074-5080.
5. Arai S, Fanale M, DeVos S, et al. Defining a Hodgkin lymphoma population for novel therapeutics after relapse from autologous hematopoietic cell transplant. Leuk Lymphoma. 2013;54(11):2531-2533.
6. Moskowitz AJ, Perales MA, 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(2):158-163.
7. Greaves P, Wilson A, Matthews J, et al. Early relapse and refractory disease remain risk factors in the anthracycline and autologous transplant era for patients with relapsed/refractory classical Hodgkin lymphoma: a single centre intention-totreat analysis. Br J Haematol. 2012;157(2):201-204.
8. Brice P, Bastion Y, Divine M, et al. Analysis of prognostic factors after the first relapse of Hodgkin's disease in 187 patients. Cancer. 1996;78(6):1293-1299.
9. Eichenauer DA, Thielen I, Haverkamp H, et al. Therapy-related acute myeloid leukemia and myelodysplastic syndromes in patients with Hodgkin lymphoma: a report from the German Hodgkin Study Group. Blood. 2014;123(11):1658-1664.
10. Wongso D, Fuchs M, Plütschow A, et al. Treatment-related mortality in patients with advanced-stage hodgkin lymphoma: an analysis of the german hodgkin study group. J Clin Oncol. 2013;31(22):2819-2824.
11. Diefenbach C, Steidl C. New strategies in Hodgkin lymphoma: better risk profiling and novel treatments. Clin Cancer Res. 2013;19(11):2797-2803.
12. Eichenauer DA, Engert A. Antibodies and antibody-drug conjugates in the treatment of Hodgkin lymphoma. Eur J Haematol. 2014;93(1):1-8.
13. Rothe A, Sasse S, Goergen H, et al. Brentuximab vedotin for relapsed or refractory CD301 hematologic malignancies: the German Hodgkin Study Group experience. Blood. 2012;120(7):1470-1472.
14. Younes A. CD30-targeted antibody therapy. Curr Opin Oncol. 2011;23(6):587-593.
15. Younes A, Gopal AK, Smith SE, et al. Results of a pivotal phase II study of brentuximab vedotin for patients with relapsed or refractory Hodgkin's lymphoma. J Clin Oncol. 2012;30(18):2183-2189.
16. Ansell SM, Lesokhin AM, Borrello I, et al. PD-1 blockade with nivolumab in relapsed or refractory Hodgkin's lymphoma. N Engl J Med. 2015;372(4):311-319.
17. Moskowitz CH, Ribrag V, Michot JM, et al. PD-1 blockade with the monoclonal antibody pembrolizumab (MK-3475) in patients with classical Hodgkin lymphoma after brentuximab vedotin failure: preliminary results from a phase 1b study. Presented at the annual meeting of the American Society of Hematology. December 8, 2014. San Francisco, CA. Available at: https://ash.confex.com/ash/2014/webprogram/Paper75615.html.
18. Fehniger TA, Larson S, Trinkaus K, et al. A phase 2 multicenter study of lenalidomide in relapsed or refractory classical Hodgkin lymphoma. Blood. 2011;118(19):5119-5125.
19. Desai M, Newberry KJ, Romaguera J, Zhang L, Ou Z, Wang M. Immunomodulation therapy with lenalidomide in follicular, transformed and diffuse large B cell lymphoma: current data on safety and efficacy. J Hematol Oncol. 2013;6:55.
20. Hartmann F, Renner C, Jung W, et al. Anti-CD16/CD30 bispecific antibody treatment for Hodgkin's disease: role of infusion schedule and costimulation with cytokines. Clin Cancer Res. 2001;7(7):1873-1881.
21. Borchmann P, Schnell R, Fuss I, et al. Phase 1 trial of the novel bispecific molecule H22xKi-4 in patients with refractory Hodgkin lymphoma. Blood. 2002;100(9):3101-3107.
22. McAleese F, Eser M. RECRUIT-TandAbs: harnessing the immune system to kill cancer cells. Future Oncol. 2012;8(6):687-695.
23. Reusch U, Burkhardt C, Fucek I, et al. A novel tetravalent bispecific TandAb (CD30/CD16A) efficiently recruits NK cells for the lysis of CD301 tumor cells. MAbs. 2014;6(3):728-739.
24. Cheson BD, Pfistner B, Juweid ME, et al; International Harmonization Project on Lymphoma. Revised response criteria for malignant lymphoma. J Clin Oncol. 2007;25(5):579-586.
25. Reiners KS, Kessler J, Sauer M, et al. Rescue of impaired NK cell activity in hodgkin lymphoma with bispecific antibodies in vitro and in patients. Mol Ther. 2013;21(4):895-903.
26. Topp MS, Kufer P, Gökbuget N, et al. Targeted therapy with the T-cell-engaging antibody blinatumomab of chemotherapyrefractory minimal residual disease in B-lineage acute lymphoblastic leukemia patients results in high response rate and prolonged leukemiafree survival. J Clin Oncol. 2011;29(18):2493-2498.
27. 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, singlearm, phase 2 study. Lancet Oncol. 2015;16(1):57-66.
28. Feng Q, Zak D, Daya R. Autoimmune hemolytic anemia and classical Hodgkin lymphoma: a case report and literature review. Clin Adv Hematol Oncol. 2012;10(4):270-276.
29. ®) blinatumomab in patients with relapsed/refractory diffuse large B-cell lymphoma [abstract]. Presented at the annual meeting of the American Society of Hematology. December 7, 2013. New Orleans, LA. Abstract 1811. Available at: https://ash.confex.com/ash/2013/webprogram/Paper59589.html.
30. Younes A, Bartlett NL, Leonard JP, et al. Brentuximab vedotin (SGN-35) for relapsed CD30-positive lymphomas. N Engl J Med. 2010;363(19):1812-1821.
31. Fox BA, Schendel DJ, Butterfield LH, et al. Defining the critical hurdles in cancer immunotherapy. J Transl Med. 2011;9:214.
32. Hoos A, Eggermont AMM, Janetzki S, et al. Improved endpoints for cancer immunotherapy trials. J Natl Cancer Inst. 2010;102(18):1388-1397.
33. Ohshima K, Tutiya T, Yamaguchi T, et al. Infiltration of Th1 and Th2 lymphocytes around Hodgkin and Reed-Sternberg (H&RS) cells in Hodgkin disease: relation with expression of CXC and CC chemokines on H&RS cells. Int J Cancer. 2002;98(4):567-572.
34. van den Berg A, Visser L, Poppema S. High expression of the CC chemokine TARC in Reed-Sternberg cells. A possible explanation for the characteristic T-cell infiltratein Hodgkin's lymphoma. Am J Pathol. 1999;154(6):1685-1691.
35. Poppema S, Potters M, Visser L, van den Berg AM. Immune escape mechanisms in Hodgkin's disease. Ann Oncol. 1998;9(Suppl 5):S21-S24.
36. Poppema S. Immunobiology and pathophysiology of Hodgkin lymphomas. Hematology Am Soc Hematol Educ Program. 2005;231-238.