{"entity":{"id":"ds-3201b-atll-phase-2","kind":"trial","name":"EZH1 and EZH2 inhibitor DS-3201b in relapsed adult T-cell leukaemia/lymphoma","aka":["DS-3201b in ATL","Izutsu 2023"],"tldr":"A tablet that blocks two enzymes controlling which genes are switched on shrank the disease in about half of people with relapsed adult T-cell leukaemia, nearly all of whom had already had mogamulizumab.","summary":"A multicentre single-arm phase 2 study in Japan of valemetostat, an oral inhibitor of the histone methyltransferases EZH2 and EZH1, in relapsed or refractory aggressive adult T-cell leukaemia/lymphoma. The primary endpoint was overall response assessed centrally by an independent committee.\n\nTwenty-five patients were enrolled, median age 69, with a median of three prior lines; 24 had already received mogamulizumab. The overall response was 48.0 per cent (90 per cent confidence interval 30.5 to 65.9), five complete and seven partial remissions, and 45.8 per cent in those previously treated with mogamulizumab. The median duration of response had not been reached. Adverse events in at least 20 per cent included thrombocytopenia, anaemia, hair loss, altered taste, neutropenia, lymphopenia, leukopenia, decreased appetite and fever. OnCo holds no drug record for valemetostat, so it is named here and not linked.","status":"positive","asOf":"2026-11-03","links":[{"label":"ClinicalTrials.gov NCT04102150","url":"https://clinicaltrials.gov/study/NCT04102150"},{"label":"Blood 2023","url":"https://doi.org/10.1182/blood.2022016862"}],"tags":["lymphoma-evidence-entities"],"related":[],"cancers":["adult-t-cell-leukaemia-lymphoma","peripheral-t-cell-lymphoma"],"sections":["epigenetics"],"technologies":["epigenetic-drugs"],"targets":["ezh2"],"drugs":[],"companies":["daiichi-sankyo"],"institutions":[],"pathways":[],"terms":["orr","lymphoma-htlv-1"],"trials":["mogamulizumab-atll-phase-2-japan"],"people":[],"bottlenecks":[],"keyPapers":["paper-izutsu-ezh1-ezh2-inhibitor-atll-blood-2023"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04102150","phase":"2","setting":"Relapsed or refractory aggressive adult T-cell leukaemia/lymphoma (acute, lymphoma and unfavourable chronic types): valemetostat, an EZH2 and EZH1 inhibitor, 200 mg daily by mouth","sponsor":"Daiichi Sankyo Co., Ltd.","result":"Overall response 48.0 per cent (12 of 25) by central review, including after mogamulizumab.","started":"2019-11-21","startedType":"actual","yearReported":2023,"enrolled":25,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall response rate (independent central review)","primary":true,"unit":"%","arms":[{"name":"Valemetostat","n":25,"value":48,"note":"90 per cent confidence interval 30.5 to 65.9; 5 complete and 7 partial remissions"}],"source":"https://doi.org/10.1182/blood.2022016862"}],"replication":"Single arm; no randomised comparison."},"route":"/trials/ds-3201b-atll-phase-2/","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":"epigenetics","kind":"section","name":"Epigenetic & Transcriptional Therapy","route":"/fronts/epigenetics/"}],"technology":[{"id":"epigenetic-drugs","kind":"technology","name":"Epigenetic drugs (HDAC, DNMT, EZH2, IDH, menin, BET)","route":"/technologies/epigenetic-drugs/"}],"target":[{"id":"ezh2","kind":"target","name":"EZH2","route":"/targets/ezh2/"}],"company":[{"id":"daiichi-sankyo","kind":"company","name":"Daiichi Sankyo","route":"/companies/daiichi-sankyo/"}],"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":"mogamulizumab-atll-phase-2-japan","kind":"trial","name":"Mogamulizumab phase 2 in relapsed adult T-cell leukaemia/lymphoma (Japan)","route":"/trials/mogamulizumab-atll-phase-2-japan/"}],"paper":[{"id":"paper-izutsu-ezh1-ezh2-inhibitor-atll-blood-2023","kind":"paper","name":"An open-label, single-arm phase 2 trial of valemetostat for relapsed or refractory adult T-cell leukemia/lymphoma","route":"/key-papers/paper-izutsu-ezh1-ezh2-inhibitor-atll-blood-2023/"}]}}