{"entity":{"id":"epcore-dlbcl-1","kind":"trial","name":"EPCORE DLBCL-1","aka":[],"tldr":"Epcoritamab delayed progression but did not clearly extend life versus chemotherapy in relapsed lymphoma, missing its US primary endpoint in January 2026.","summary":"EPCORE DLBCL-1, trial NCT04628494 sponsored by Genmab and AbbVie and reported on 16 January 2026, was the confirmatory phase 3 for epcoritamab in relapsed or refractory diffuse large B-cell lymphoma after at least one line in transplant-ineligible patients, and it delayed progression but did not clearly extend life against investigator's choice of rituximab-gemcitabine-oxaliplatin or bendamustine-rituximab. It randomised 552 patients and improved progression-free survival, but overall survival, the sole primary endpoint in the United States, was not significantly different, so the study did not meet its US endpoint while the dual endpoints used elsewhere were partially met. The regulatory implications for the accelerated approval were under discussion, and whether a bispecific alone can beat chemotherapy on survival is the open question.","status":"mixed","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT04628494","url":"https://clinicaltrials.gov/study/NCT04628494"}],"tags":[],"related":[],"cancers":["dlbcl"],"sections":[],"technologies":["t-cell-engager"],"targets":[],"drugs":["epcoritamab"],"companies":["genmab"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["catherine-thieblemont"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04628494","phase":"3","setting":"R/R DLBCL after ≥1 line, transplant-ineligible: epcoritamab monotherapy vs investigator's choice (R-GemOx or BR)","sponsor":"Genmab / AbbVie","result":"PFS HR 0.74; OS HR 0.96 (NS).","started":"2021-01-13","startedType":"actual","yearReported":2026,"enrolled":552,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival","primary":true,"arms":[{"name":"Epcoritamab"},{"name":"Investigator's choice"}],"hr":0.96,"ci":[0.77,1.2],"source":"https://ir.genmab.com/news-releases/news-release-details/genmab-announces-topline-results-epcoritamab-duobodyr-cd3xcd20/"},{"endpoint":"Progression-free survival","arms":[{"name":"Epcoritamab"},{"name":"Investigator's choice"}],"hr":0.74,"ci":[0.6,0.92]}]},"route":"/trials/epcore-dlbcl-1/","neighbours":{"cancer":[{"id":"dlbcl","kind":"cancer","name":"Diffuse large B-cell lymphoma","route":"/cancers/dlbcl/"}],"technology":[{"id":"t-cell-engager","kind":"technology","name":"T-cell engagers (bispecific)","route":"/technologies/t-cell-engager/"}],"drug":[{"id":"epcoritamab","kind":"drug","name":"Epcoritamab","route":"/drugs/epcoritamab/"}],"company":[{"id":"genmab","kind":"company","name":"Genmab","route":"/companies/genmab/"}],"person":[{"id":"catherine-thieblemont","kind":"person","name":"Catherine Thieblemont","route":"/people/catherine-thieblemont/"}],"idea":[{"id":"idea-ctdna-guided-dlbcl-frontline","kind":"idea","name":"ctDNA-guided escalation and de-escalation in frontline DLBCL","route":"/ideas/idea-ctdna-guided-dlbcl-frontline/"}],"term":[{"id":"lymphoma-tx-bispecific-step-up","kind":"term","name":"CD20 bispecific antibodies: step-up dosing, fixed duration and what it is like to take one","route":"/terms/lymphoma-tx-bispecific-step-up/"}],"paper":[{"id":"paper-epcore-nhl-1-epcoritamab-jco-2023","kind":"paper","name":"EPCORE NHL-1: epcoritamab, a subcutaneous CD20 x CD3 bispecific, in relapsed large B-cell lymphoma including after CAR-T","route":"/key-papers/paper-epcore-nhl-1-epcoritamab-jco-2023/"}]}}