{"entity":{"id":"epcore-nhl-1","kind":"trial","name":"EPCORE NHL-1","aka":[],"tldr":"EPCORE NHL-1 was the pivotal single-arm study behind epcoritamab's approval; about half of complete responders are still in remission at three years.","summary":"EPCORE NHL-1, trial NCT03625037 sponsored by Genmab and AbbVie and reported in 2022, was the pivotal single-arm study behind epcoritamab's approval in relapsed or refractory large B-cell lymphoma after at least two lines, and about half of complete responders remain in remission at three years. In the 157-patient expansion cohort the objective response rate was 63 percent with complete responses in 39 percent, cytokine release syndrome occurred in about half but was rarely severe, and the three-year follow-up found many complete responders with undetectable circulating tumour DNA. Without a randomised comparison, and with the confirmatory EPCORE DLBCL-1 missing its US survival endpoint, whether the drug improves survival over chemotherapy is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT03625037","url":"https://clinicaltrials.gov/study/NCT03625037"}],"tags":[],"related":["lymphoma-roadmap","polargo","starglo"],"cancers":["dlbcl"],"sections":[],"technologies":["t-cell-engager"],"targets":[],"drugs":["epcoritamab"],"companies":["genmab"],"institutions":[],"pathways":[],"terms":["orr","crs"],"trials":[],"people":["catherine-thieblemont"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03625037","phase":"1/2","setting":"R/R LBCL after ≥2 lines (single-arm expansion): epcoritamab monotherapy","sponsor":"Genmab / AbbVie","result":"ORR 63%, CR 39%.","started":"2018-06-26","startedType":"actual","yearReported":2022,"enrolled":157,"enrolledBasis":"registry","outcomes":[{"endpoint":"Objective response rate","primary":true,"unit":"%","arms":[{"name":"Epcoritamab","n":157,"value":63.1}],"source":"https://ascopubs.org/doi/10.1200/JCO.22.01725"},{"endpoint":"Complete response rate","unit":"%","arms":[{"name":"Epcoritamab","n":157,"value":38.9}],"source":"https://doi.org/10.1200/JCO.22.01725"}]},"route":"/trials/epcore-nhl-1/","neighbours":{"roadmap":[{"id":"lymphoma-roadmap","kind":"roadmap","name":"Lymphoma roadmap: from a jaw tumour in Uganda and the first human cancer virus to gene-expression subtypes, PET-adapted chemotherapy, CAR-T cells, bispecific antibodies and the genetics-directed trials now recruiting","route":"/roadmaps/lymphoma-roadmap/"}],"trial":[{"id":"polargo","kind":"trial","name":"POLARGO","route":"/trials/polargo/"},{"id":"starglo","kind":"trial","name":"STARGLO","route":"/trials/starglo/"}],"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/"}],"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/"},{"id":"crs","kind":"term","name":"Cytokine release syndrome (CRS)","route":"/terms/crs/"},{"id":"orr","kind":"term","name":"Objective response rate (ORR)","route":"/terms/orr/"}],"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/"}],"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/"}]}}