Phase 1/2 study of mogamulizumab, a defucosylated anti-CCR4 antibody, in previously treated patients with cutaneous T-cell lymphoma

Blood

Volumn 125, Issue 12, 2015, Pages 1883-1889

  Duvic, Madeleine ^a   Pinter Brown, Lauren C ^b   Foss, Francine M ^c   Sokol, Lubomir ^d   Jorgensen, Jeffrey L ^a   Challagundla, Pramoda ^a   Dwyer, Karen M ^e   Zhang, Xiaoping ^e   Kurman, Michael R ^e   Ballerini, Rocco ^e   Liu, Li ^f   Kim, Youn H ^g  

^a UNIVERSITY OF TEXAS   (United States)

^b UNIVERSITY OF CALIFORNIA   (United States)

^c YALE NEW HAVEN HOSPITAL   (United States)

^d H LEE MOFFITT CANCER CENTER AND RESEARCH INSTITUTE   (United States)

^e KYOWA HAKKO KOGYO CO LTD   (Japan)

^f ReSearch Pharmaceutical Services Inc ^*  (United States)

^g STANFORD CANCER INSTITUTE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ALEMTUZUMAB; BORTEZOMIB; CHEMOKINE RECEPTOR CCR4; DENILEUKIN DIFTITOX; HISTONE DEACETYLASE INHIBITOR; INTERFERON; LENALIDOMIDE; MOGAMULIZUMAB; PSORALEN; RETINOID; STEROID; CCR4 PROTEIN, HUMAN; MONOCLONAL ANTIBODY;

ABDOMINAL PAIN; ADULT; AGED; AREA UNDER THE CURVE; ARTICLE; BLEEDING; CANCER FATIGUE; CANCER GROWTH; CANCER IMMUNOTHERAPY; CANCER PATIENT; CANCER RADIOTHERAPY; CANCER RECURRENCE; CANCER STAGING; CANCER SURVIVAL; CHEMOTHERAPY INDUCED EMESIS; CHILL; CLINICAL ARTICLE; CLINICAL EFFECTIVENESS; COMPUTER ASSISTED EMISSION TOMOGRAPHY; CUTANEOUS T CELL LYMPHOMA; DRUG DOSE ESCALATION; DRUG EFFICACY; DRUG ERUPTION; DRUG FEVER; DRUG HALF LIFE; DRUG INDUCED HEADACHE; DRUG SAFETY; DRUG WITHDRAWAL; ELECTRON THERAPY; ELIMINATION HALF-LIFE; EXPERIMENTAL THERAPY; EXTERNAL BEAM RADIOTHERAPY; FEBRILE NEUTROPENIA; HUMAN; HUMAN TISSUE; HYPOTENSION; INFUSION RELATED REACTION; LYMPHOCYTIC INFILTRATION; LYMPHOCYTOPENIA; MALE; MAXIMUM PLASMA CONCENTRATION; MAXIMUM TOLERATED DOSE; MINIMUM PLASMA CONCENTRATION; MULTICENTER STUDY; MULTIMODALITY CANCER THERAPY; MYCOSIS FUNGOIDES; NAUSEA; NEUTROPENIA; OPEN STUDY; PHASE 1 CLINICAL TRIAL; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; PROTEIN EXPRESSION; PSEUDOLYMPHOMA; PSORIASIS; PUVA; RETREATMENT; SEZARY SYNDROME; SKIN BIOPSY; SKIN INFECTION; SKIN PRURITUS; SYSTEMIC THERAPY; THROMBOCYTOPENIA; TREATMENT DURATION; TREATMENT RESPONSE; ULTRAVIOLET A RADIATION; ULTRAVIOLET B RADIATION; UPPER RESPIRATORY TRACT INFECTION; CLINICAL TRIAL; DRUG ADMINISTRATION; FEMALE; IMMUNOLOGY; LYMPHOMA, T-CELL, CUTANEOUS; MIDDLE AGED; PROGNOSIS; TREATMENT OUTCOME; VERY ELDERLY;

ADULT; AGED; AGED, 80 AND OVER; ANTIBODIES, MONOCLONAL, HUMANIZED; DRUG ADMINISTRATION SCHEDULE; FEMALE; HUMANS; LYMPHOMA, T-CELL, CUTANEOUS; MALE; MAXIMUM TOLERATED DOSE; MIDDLE AGED; MYCOSIS FUNGOIDES; PROGNOSIS; RECEPTORS, CCR4; SEZARY SYNDROME; TREATMENT OUTCOME;

EID: 84925345390     PISSN: 00064971     EISSN: 15280020     Source Type: Journal    
DOI: 10.1182/blood-2014-09-600924     Document Type: Article

References (34)

1. Olsen E, Vonderheid E, Pimpinelli N, et al ISCL/EORTC. Revisions to the staging and classification of mycosis fungoides and Sezary syndrome: a proposal of the International Society for Cutaneous Lymphomas (ISCL) and the cutaneous lymphoma task force of the European Organization of Research and Treatment of Cancer (EORTC). Blood. 2007A;110(6):1713-1722.
2. Campbell JJ, Clark RA, Watanabe R, Kupper TS. Sezary syndrome and mycosis fungoides arise from distinct T-cell subsets: a biologic rationale for their distinct clinical behaviors. Blood. 2010;116(5):767-771.
3. Agar NS, Wedgeworth E, Crichton S, et al. Survival outcomes and prognostic factors in mycosis fungoides/Sézary syndrome: validation of the revised International Society for Cutaneous Lymphomas/European Organisation for Research and Treatment of Cancer staging proposal. J Clin Oncol. 2010;28(31):4730-4739.
4. Quaglino P, Pimpinelli N, Berti E, et al Gruppo Italiano Linfomi Cutanei. Time course, clinical pathways, and long-term hazards risk trends of disease progression in patients with classic mycosis fungoides: a multicenter, retrospective follow-up study from the Italian Group of Cutaneous Lymphomas. Cancer. 2012;118(23):5830-5839.
5. Talpur R, Singh L, Daulat S, et al. Long-term outcomes of 1,263 patients with mycosis fungoides and Sézary syndrome from 1982 to 2009. Clin Cancer Res. 2012;18(18):5051-5060.
6. Vidulich KA, Talpur R, Bassett RL, Duvic M. Overall survival in erythrodermic cutaneous T-cell lymphoma: an analysis of prognostic factors in a cohort of patients with erythrodermic cutaneous T-cell lymphoma. Int J Dermatol. 2009;48(3):243-252.
7. Duvic M, Donato M, Dabaja B, et al. Total skin electron beam and non-myeloablative allogeneic hematopoietic stem-cell transplantation in advanced mycosis fungoides and Sezary syndrome. J Clin Oncol. 2010;28(14):2365-2372.
8. Imai T, Nagira M, Takagi S, et al. Selective recruitment of CCR4-bearing Th2 cells toward antigen-presenting cells by the CC chemokines thymus and activation-regulated chemokine and macrophage-derived chemokine. Int Immunol. 1999;11(1):81-88.
9. Ishida T, Iida S, Akatsuka Y, et al. The CC chemokine receptor 4 as a novel specific molecular target for immunotherapy in adult T-Cell leukemia/lymphoma. Clin Cancer Res. 2004A;10(22):7529-7539.
10. Ishida T, Inagaki H, Utsunomiya A, et al. CXC chemokine receptor 3 and CC chemokine receptor 4 expression in T-cell and NK-cell lymphomas with special reference to clinicopathological significance for peripheral T-cell lymphoma, unspecified. Clin Cancer Res. 2004B;10(16):5494-5500.
11. Kakinuma T, Sugaya M, Nakamura K, et al. Thymus and activation-regulated chemokine (TARC/CCL17) in mycosis fungoides: serum TARC levels reflect the disease activity of mycosis fungoides. J Am Acad Dermatol. 2003;48(1):23-30.
12. Hristov AC, Vonderheid EC, Borowitz MJ. Simplified flow cytometric assessment in mycosis fungoides and Sézary syndrome. Am J Clin Pathol. 2011;136(6):944-953.
13. Ohshima K, Karube K, Kawano R, et al. Classification of distinct subtypes of peripheral T-cell lymphoma unspecified, identified by chemokine and chemokine receptor expression: analysis of prognosis. Int J Oncol. 2004;25(3):605-613.
14. Ishida T, Utsunomiya A, Iida S, et al. Clinical significance of CCR4 expression in adult T-cell leukemia/lymphoma: its close association with skin involvement and unfavorable outcome. Clin Cancer Res. 2003;9(10 Pt 1):3625-3634.
15. Ishida T, Joh T, Uike N, et al. Defucosylated anti-CCR4 monoclonal antibody (KW-0761) for relapsed adult T-cell leukemia-lymphoma: a multicenter phase II study. J Clin Oncol. 2012;30(8):837-842.
16. Yamamoto K, Utsunomiya A, Tobinai K, et al. Phase I study of KW-0761, a defucosylated humanized anti-CCR4 antibody, in relapsed patients with adult T-cell leukemia-lymphoma and peripheral T-cell lymphoma. J Clin Oncol. 2010;28(9):1591-1598.
17. Yano H, Ishida T, Inagaki A, et al. Defucosylated anti CC chemokine receptor 4 monoclonal antibody combined with immunomodulatory cytokines: a novel immunotherapy for aggressive/refractory Mycosis fungoides and Sezary syndrome. Clin Cancer Res. 2007;13(21):6494-6500.
18. Ito A, Ishida T, Yano H, et al. Defucosylated anti-CCR4 monoclonal antibody exercises potent ADCC-mediated antitumor effect in the novel tumor-bearing humanized NOD/Shi-scid, IL-2Rgamma(null) mouse model. Cancer Immunol Immunother. 2009;58(8):1195-1206.
19. Shinkawa T, Nakamura K, Yamane N, et al. The absence of fucose but not the presence of galactose or bisecting N-acetylglucosamine of human IgG1 complex-type oligosaccharides shows the critical role of enhancing antibody-dependent cellular cytotoxicity. J Biol Chem. 2003;278(5):3466-3473.
20. Olsen EA, Whittaker S, Kim YH, et al International Society for Cutaneous Lymphomas; United States Cutaneous Lymphoma Consortium; Cutaneous Lymphoma Task Force of the European Organisation for Research and Treatment of Cancer. Clinical end points and response criteria in mycosis fungoides and Sézary syndrome: a consensus statement of the International Society for Cutaneous Lymphomas, the United States Cutaneous Lymphoma Consortium, and the Cutaneous Lymphoma Task Force of the European Organisation for Research and Treatment of Cancer. J Clin Oncol. 2011;29(18):2598-2607.
21. Stevens SR, Ke MS, Parry EJ, Mark J, Cooper KD. Quantifying skin disease burden in mycosis fungoides-type cutaneous T-cell lymphomas: the severity-weighted assessment tool (SWAT). Arch Dermatol. 2002;138(1):42-48.
22. Jones D, Dang NH, Duvic M, Washington LT, Huh YO. Absence of CD26 expression is a useful marker for diagnosis of T-cell lymphoma in peripheral blood. Am J Clin Pathol. 2001;115(6):885-892.
23. Martin SJ, Duvic M. Prevalence and treatment of palmoplantar keratoderma and tinea pedis in patients with Sézary syndrome. Int J Dermatol. 2012;51(10):1195-1198.
24. Talpur R, Bassett R, Duvic M. Prevalence and treatment of Staphylococcus aureus colonization in patients with mycosis fungoides and Sézary syndrome. Br J Dermatol. 2008;159(1):105-112.
25. Pulitzer MP, Nolan KA, Oshman RG, Phelps RG. CD301 lymphomatoid drug reactions. Am J Dermatopathol. 2013;35(3):343-350.
26. Guitart J, Querfeld C. Cutaneous CD30 lymphoproliferative disorders and similar conditions: a clinical and pathologic prospective on a complex issue. Semin Diagn Pathol. 2009;26(3):131-140.
27. Duvic M, Talpur R, Ni X, et al. Phase 2 trial of oral vorinostat (suberoylanilide hydroxamic acid, SAHA) for refractory cutaneous T-cell lymphoma (CTCL). Blood. 2007;109(1):31-39.
28. Olsen EA, Kim YH, Kuzel TM, et al. Phase IIb multicenter trial of vorinostat in patients with persistent, progressive, or treatment refractory cutaneous T-cell lymphoma. J Clin Oncol. 2007B;25(21):3109-3115.
29. Prince HM, Dickinson M. Romidepsin for cutaneous T-cell lymphoma. Clin Cancer Res. 2012;18(13):3509-3515.
30. Horwitz SM, Kim YH, Foss F, et al. Identification of an active, well-tolerated dose of pralatrexate in patients with relapsed or refractory cutaneous T-cell lymphoma. Blood. 2012;119(18):4115-4122.
31. Bloom T, Kuzel TM, Querfeld C, Guitart J, Rosen ST. Cutaneous T-cell lymphomas: a review of new discoveries and treatments. Curr Treat Options Oncol. 2012;13(1):102-121.
32. Ogura M, Ishida T, Hatake K, et al. Multicenter phase II study of mogamulizumab (KW-0761), a defucosylated anti-cc chemokine receptor 4 antibody, in patients with relapsed peripheral T-cell lymphoma and cutaneous T-cell lymphoma. J Clin Oncol. 2014;32(11):1157-1163.
33. Ponti R, Fierro MT, Quaglino P, et al. TCRgamma-chain gene rearrangement by PCR-based GeneScan: diagnostic accuracy improvement and clonal heterogeneity analysis in multiple cutaneous T-cell lymphoma samples. J Invest Dermatol. 2008;128(4):1030-1038.
34. Umino A, Nakagawa M, Utsunomiya A, et al. Clonal evolution of adult T-cell leukemia/lymphoma takes place in the lymph nodes. Blood. 2011;117(20):5473-5478.