{"entity":{"id":"brentuximab-salcl-phase-2","kind":"trial","name":"Brentuximab vedotin phase 2 in relapsed systemic anaplastic large cell lymphoma (SG035-0004)","aka":["SG035-0004","Pro 2012"],"tldr":"An antibody-drug conjugate aimed at CD30 made the lymphoma shrink in 86 per cent of people with relapsed anaplastic large cell lymphoma, and disappear on scans in more than half.","summary":"Systemic anaplastic large cell lymphoma uniformly expresses CD30. Brentuximab vedotin is an antibody against CD30 joined to monomethyl auristatin E, a drug that disrupts microtubules. This multicentre phase 2 study gave it at 1.8 mg/kg intravenously every three weeks, as an outpatient infusion, to 58 patients with systemic ALCL that had come back after at least one treatment; the primary endpoint was objective response by independent central review.\n\nFifty patients (86 per cent) responded and 33 (57 per cent) had a complete remission. The median durations of response and of complete remission were 12.6 and 13.2 months. Grade 3 or 4 adverse events in at least 10 per cent were neutropenia (21 per cent), thrombocytopenia (14 per cent) and peripheral sensory neuropathy (12 per cent). The five-year report (Blood 2017) found no progressions beyond 40 months and eight patients, 14 per cent of those enrolled, in sustained remission with neither a transplant nor any further treatment. The drug was approved in the United States in 2011 for relapsed systemic ALCL, and ECHELON-2 later moved it to first line.","status":"positive","asOf":"2026-11-03","links":[{"label":"ClinicalTrials.gov NCT00866047","url":"https://clinicaltrials.gov/study/NCT00866047"},{"label":"Journal of Clinical Oncology 2012","url":"https://doi.org/10.1200/JCO.2011.38.0402"},{"label":"Blood 2017: five-year results","url":"https://doi.org/10.1182/blood-2017-05-780049"}],"tags":["lymphoma-evidence-entities"],"related":[],"cancers":["alk-positive-anaplastic-large-cell-lymphoma","alk-negative-anaplastic-large-cell-lymphoma","peripheral-t-cell-lymphoma"],"sections":["adcs"],"technologies":["adc"],"targets":["cd30"],"drugs":["brentuximab-vedotin"],"companies":["pfizer"],"institutions":[],"pathways":[],"terms":["orr","complete-response"],"trials":["echelon-2"],"people":[],"bottlenecks":[],"keyPapers":["paper-brentuximab-relapsed-salcl-phase-2-jco-2012","paper-brentuximab-relapsed-salcl-five-year-blood-2017"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00866047","phase":"2","setting":"Relapsed or refractory systemic anaplastic large cell lymphoma after at least one prior therapy: brentuximab vedotin 1.8 mg/kg every three weeks","sponsor":"Seagen Inc.","result":"Objective response 86 per cent and complete remission 57 per cent in 58 patients with relapsed systemic ALCL.","started":"2009-03","yearReported":2012,"enrolled":58,"enrolledBasis":"registry","outcomes":[{"endpoint":"Objective response rate (independent central review)","primary":true,"unit":"%","arms":[{"name":"Brentuximab vedotin","n":58,"value":86}],"source":"https://doi.org/10.1200/JCO.2011.38.0402"},{"endpoint":"Complete remission rate","unit":"%","arms":[{"name":"Brentuximab vedotin","n":58,"value":57}],"source":"https://doi.org/10.1200/JCO.2011.38.0402"}],"replication":"Not repeated in relapsed disease; the randomised ECHELON-2 then tested the drug in first line and lengthened survival."},"route":"/trials/brentuximab-salcl-phase-2/","neighbours":{"cancer":[{"id":"alk-negative-anaplastic-large-cell-lymphoma","kind":"cancer","name":"ALK-negative anaplastic large cell lymphoma","route":"/cancers/alk-negative-anaplastic-large-cell-lymphoma/"},{"id":"alk-positive-anaplastic-large-cell-lymphoma","kind":"cancer","name":"ALK-positive anaplastic large cell lymphoma","route":"/cancers/alk-positive-anaplastic-large-cell-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":"adcs","kind":"section","name":"Antibody-Drug Conjugates","route":"/fronts/adcs/"}],"technology":[{"id":"adc","kind":"technology","name":"Antibody-drug conjugate (ADC)","route":"/technologies/adc/"}],"target":[{"id":"cd30","kind":"target","name":"CD30","route":"/targets/cd30/"}],"drug":[{"id":"brentuximab-vedotin","kind":"drug","name":"Brentuximab vedotin","route":"/drugs/brentuximab-vedotin/"}],"company":[{"id":"pfizer","kind":"company","name":"Pfizer (incl. Seagen)","route":"/companies/pfizer/"}],"term":[{"id":"complete-response","kind":"term","name":"Complete response","route":"/terms/complete-response/"},{"id":"orr","kind":"term","name":"Objective response rate (ORR)","route":"/terms/orr/"}],"trial":[{"id":"echelon-2","kind":"trial","name":"ECHELON-2","route":"/trials/echelon-2/"}],"paper":[{"id":"paper-brentuximab-relapsed-salcl-phase-2-jco-2012","kind":"paper","name":"Brentuximab vedotin (SGN-35) in patients with relapsed or refractory systemic anaplastic large-cell lymphoma: results of a phase II study","route":"/key-papers/paper-brentuximab-relapsed-salcl-phase-2-jco-2012/"},{"id":"paper-brentuximab-relapsed-salcl-five-year-blood-2017","kind":"paper","name":"Five-year results of brentuximab vedotin in patients with relapsed or refractory systemic anaplastic large cell lymphoma","route":"/key-papers/paper-brentuximab-relapsed-salcl-five-year-blood-2017/"}]}}