{"entity":{"id":"mogamulizumab-atll-phase-2-japan","kind":"trial","name":"Mogamulizumab phase 2 in relapsed adult T-cell leukaemia/lymphoma (Japan)","aka":["KW-0761 phase 2","Ishida 2012"],"tldr":"An antibody against CCR4, a protein on the surface of most adult T-cell leukaemia cells, produced a response in half of the people in a Japanese study whose disease had come back after chemotherapy.","summary":"Adult T-cell leukaemia/lymphoma is usually resistant to chemotherapy, and most tumours carry the chemokine receptor CCR4. Mogamulizumab is a defucosylated anti-CCR4 antibody engineered for stronger antibody-dependent cellular cytotoxicity. This Japanese multicentre phase 2 study gave it at 1.0 mg/kg once a week for eight weeks to patients with relapsed aggressive CCR4-positive disease; the primary endpoint was overall response.\n\nOf 28 patients enrolled, 27 received at least one infusion. Thirteen of 26 evaluable patients responded, eight of them completely: an overall response of 50 per cent (95 per cent confidence interval 30 to 70). Median progression-free survival was 5.2 months and median overall survival 13.7 months. The commonest adverse events were infusion reactions (89 per cent) and skin rashes (63 per cent). An updated analysis of the 26 relapsed patients (Cancer Science 2017) gave a median overall survival of 14.4 months and found that patients who developed a rash of grade 2 or more did better, which the entity page describes.","status":"positive","asOf":"2026-11-03","links":[{"label":"ClinicalTrials.gov NCT00920790","url":"https://clinicaltrials.gov/study/NCT00920790"},{"label":"Journal of Clinical Oncology 2012","url":"https://doi.org/10.1200/JCO.2011.37.3472"},{"label":"Cancer Science 2017: updated follow-up","url":"https://doi.org/10.1111/cas.13343"}],"tags":["lymphoma-evidence-entities"],"related":[],"cancers":["adult-t-cell-leukaemia-lymphoma","peripheral-t-cell-lymphoma"],"sections":["immunotherapy"],"technologies":["monoclonal-antibody"],"targets":["ccr4"],"drugs":["mogamulizumab"],"companies":["kyowa-kirin"],"institutions":[],"pathways":[],"terms":["orr","lymphoma-htlv-1"],"trials":["mogamulizumab-atll-0761-009","mlsg15-mogamulizumab-atll"],"people":[],"bottlenecks":[],"keyPapers":["paper-mogamulizumab-relapsed-atll-phase-2-jco-2012"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00920790","phase":"2","setting":"Relapsed aggressive CCR4-positive adult T-cell leukaemia/lymphoma: mogamulizumab (KW-0761) 1.0 mg/kg weekly for eight weeks","sponsor":"Kyowa Kirin Co., Ltd.","result":"Overall response 50 per cent (13 of 26), eight complete; median progression-free survival 5.2 months and overall survival 13.7 months.","started":"2009-06","yearReported":2012,"enrolled":28,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall response rate","primary":true,"unit":"%","arms":[{"name":"Mogamulizumab","n":26,"value":50,"note":"95 per cent confidence interval 30 to 70; eight complete responses"}],"source":"https://doi.org/10.1200/JCO.2011.37.3472"},{"endpoint":"Progression-free survival (median)","unit":"months","arms":[{"name":"Mogamulizumab","n":27,"value":5.2}],"source":"https://doi.org/10.1200/JCO.2011.37.3472"},{"endpoint":"Overall survival (median)","unit":"months","arms":[{"name":"Mogamulizumab","n":27,"value":13.7,"note":"14.4 months in the 2017 updated analysis of the 26 relapsed patients"}],"source":"https://doi.org/10.1200/JCO.2011.37.3472"}],"replication":"The international randomised phase 2 study 0761-009 in the United States, Europe and Latin America found a much lower confirmed response rate (11 per cent), in a population with different subtypes and more prior treatment."},"route":"/trials/mogamulizumab-atll-phase-2-japan/","neighbours":{"cancer":[{"id":"adult-t-cell-leukaemia-lymphoma","kind":"cancer","name":"Adult T-cell leukaemia/lymphoma","route":"/cancers/adult-t-cell-leukaemia-lymphoma/"},{"id":"peripheral-t-cell-lymphoma","kind":"cancer","name":"Peripheral T-cell lymphomas (including cutaneous T-cell lymphoma)","route":"/cancers/peripheral-t-cell-lymphoma/"}],"section":[{"id":"immunotherapy","kind":"section","name":"Immunotherapy","route":"/fronts/immunotherapy/"}],"technology":[{"id":"monoclonal-antibody","kind":"technology","name":"Monoclonal antibodies","route":"/technologies/monoclonal-antibody/"}],"target":[{"id":"ccr4","kind":"target","name":"CCR4","route":"/targets/ccr4/"}],"drug":[{"id":"mogamulizumab","kind":"drug","name":"Mogamulizumab","route":"/drugs/mogamulizumab/"}],"company":[{"id":"kyowa-kirin","kind":"company","name":"Kyowa Kirin","route":"/companies/kyowa-kirin/"}],"term":[{"id":"lymphoma-htlv-1","kind":"term","name":"HTLV-1 (human T-lymphotropic virus type 1)","route":"/terms/lymphoma-htlv-1/"},{"id":"orr","kind":"term","name":"Objective response rate (ORR)","route":"/terms/orr/"}],"trial":[{"id":"ds-3201b-atll-phase-2","kind":"trial","name":"EZH1 and EZH2 inhibitor DS-3201b in relapsed adult T-cell leukaemia/lymphoma","route":"/trials/ds-3201b-atll-phase-2/"},{"id":"mlsg15-mogamulizumab-atll","kind":"trial","name":"mLSG15 with or without mogamulizumab","route":"/trials/mlsg15-mogamulizumab-atll/"},{"id":"mogamulizumab-atll-0761-009","kind":"trial","name":"Study 0761-009: mogamulizumab against investigator's choice in relapsed adult T-cell leukaemia/lymphoma","route":"/trials/mogamulizumab-atll-0761-009/"}],"paper":[{"id":"paper-mogamulizumab-relapsed-atll-phase-2-jco-2012","kind":"paper","name":"Defucosylated anti-CCR4 monoclonal antibody (KW-0761) for relapsed adult T-cell leukemia-lymphoma: a multicenter phase II study","route":"/key-papers/paper-mogamulizumab-relapsed-atll-phase-2-jco-2012/"}]}}