{"entity":{"id":"epcoritamab","kind":"drug","name":"Epcoritamab","aka":[],"tldr":"Epcoritamab is an under-the-skin injection that pulls T cells onto lymphoma cells; it is approved for relapsed large B-cell and follicular lymphoma, and moving toward first line.","summary":"EPCORE NHL-1: ORR 63%, CR 39% in DLBCL after ≥2 lines; 3-year data show ~53% of complete responders in durable remission. Accelerated approval May 2023 (DLBCL) and 2024 (follicular lymphoma). Phase 3 EPCORE DLBCL-1 (R/R, vs investigator's choice, topline January 2026): PFS HR 0.74 but OS HR 0.96, not significant, so the US primary endpoint was missed. EPCORE DLBCL-2 (frontline, with R-CHOP) topline 2026 and EHA 2026 presentation; EPCORE FL-1 positive in follicular lymphoma. Genmab/AbbVie; 2025 label change allowed outpatient step-up dosing.","status":"approved","asOf":"2026-09-07","wikipedia":"https://en.wikipedia.org/wiki/Epcoritamab","links":[{"label":"FDA label (DailyMed)","url":"https://dailymed.nlm.nih.gov/dailymed/search.cfm?query=Epcoritamab"}],"tags":[],"related":[],"cancers":["dlbcl"],"sections":[],"technologies":["t-cell-engager"],"targets":["cd20","cd3"],"drugs":[],"companies":["genmab","abbvie"],"institutions":[],"pathways":[],"terms":["crs","icans","step-up-dosing"],"trials":["epcore-nhl-1","epcore-dlbcl-1","epcore-dlbcl-2","nct07226752","nct06508658","nct06191744","nct05409066","nct06090539","nct04542824","nct05201248","nct05451810","nct05283720","nct04623541"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"brand":"Epkinly","modality":"Bispecific T-cell engager (CD20×CD3)","mechanism":"DuoBody IgG1 binding CD20 on B cells and CD3 on T cells, forming a cytolytic synapse; subcutaneous step-up dosing to limit CRS.","approvals":[{"region":"US","year":2023,"indication":"Relapsed/refractory DLBCL or high-grade B-cell lymphoma after ≥2 lines (accelerated)"},{"region":"US","year":2024,"indication":"Relapsed/refractory follicular lymphoma after ≥2 lines (accelerated; full 2025 with R2)"},{"region":"EU","year":2023,"indication":"EU brand Tepkinly","note":"Conditional marketing authorisation"}],"mechanismSteps":["Subcutaneous injection; slow absorption blunts cytokine peaks","One arm binds CD20 on the lymphoma cell","Other arm engages CD3 on any nearby T cell","T cell activates, releases perforin and granzymes","Serial killing of CD20+ cells; CRS mainly in cycle 1"],"dosing":{"route":"Subcutaneous","schedule":"Step-up 0.16 mg (day 1), 0.8 mg (day 8), then 48 mg weekly cycles 1-3, every 2 weeks cycles 4-9, then every 4 weeks until progression","monitoring":"CRS and ICANS after the first full dose; infections; CMV","source":"https://www.epkinly.com"},"toxicity":[{"event":"Cytokine release syndrome","anyGradePct":49.7,"grade3PlusPct":2.5,"note":"EPCORE NHL-1 DLBCL cohort"},{"event":"ICANS","anyGradePct":6.4,"grade3PlusPct":0.6},{"event":"Neutropenia","grade3PlusPct":14.6},{"event":"Infections","grade3PlusPct":14.6}],"access":[],"regulatoryEvents":[{"date":"2023-05-19","type":"accelerated-approval","region":"US","note":"Accelerated approval in DLBCL (EPCORE NHL-1) The confirmatory requirement was still open 3.3 years later, when the FDA's table was read.","indication":"Adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from indolent lymphoma, and high-grade B-cell lymphoma after two or more lines of systemic therapy."},{"date":"2024-06-24","type":"accelerated-approval","region":"US","note":"Accelerated approval on a surrogate endpoint, with a confirmatory trial required.","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-epcoritamab-bysp-relapsed-or-refractory-follicular-lymphoma","indication":"Treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy"},{"date":"2025-11-18","type":"conversion","region":"US","note":"Confirmed: the accelerated approval of 2024 converted to traditional approval 1.4 years after it was granted.","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-epcoritamab-bysp-relapsed-or-refractory-follicular-lymphoma","indication":"Treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy"},{"date":"2026-01-16","type":"filing","region":"US","note":"EPCORE DLBCL-1 topline: PFS met, OS (US primary endpoint) not met","source":"https://news.abbvie.com/2026-01-16-AbbVie-Announces-Topline-Results-for-Epcoritamab-DuoBody-R-CD3xCD20-from-Phase-3-EPCORE-R-DLBCL-1-Trial-in-Patients-with-Relapsed-Refractory-Diffuse-Large-B-cell-Lymphoma-DLBCL"}]},"route":"/drugs/epcoritamab/","neighbours":{"cancer":[{"id":"dlbcl","kind":"cancer","name":"Diffuse large B-cell lymphoma","route":"/cancers/dlbcl/"},{"id":"follicular-lymphoma","kind":"cancer","name":"Follicular lymphoma","route":"/cancers/follicular-lymphoma/"},{"id":"hiv-associated-lymphoma","kind":"cancer","name":"HIV-associated (AIDS-related) lymphomas","route":"/cancers/hiv-associated-lymphoma/"},{"id":"non-hodgkin-lymphoma","kind":"cancer","name":"Non-Hodgkin lymphoma (all types)","route":"/cancers/non-hodgkin-lymphoma/"},{"id":"post-transplant-lymphoproliferative-disorder","kind":"cancer","name":"Post-transplant lymphoproliferative disorder (PTLD)","route":"/cancers/post-transplant-lymphoproliferative-disorder/"},{"id":"primary-mediastinal-b-cell-lymphoma","kind":"cancer","name":"Primary mediastinal (thymic) large B-cell lymphoma","route":"/cancers/primary-mediastinal-b-cell-lymphoma/"}],"technology":[{"id":"t-cell-engager","kind":"technology","name":"T-cell engagers (bispecific)","route":"/technologies/t-cell-engager/"}],"target":[{"id":"cd20","kind":"target","name":"CD20","route":"/targets/cd20/"},{"id":"cd3","kind":"target","name":"CD3","route":"/targets/cd3/"}],"company":[{"id":"abbvie","kind":"company","name":"AbbVie (incl. ImmunoGen, Capstan)","route":"/companies/abbvie/"},{"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":"lymphoma-tx-crs-icans","kind":"term","name":"Cytokine release syndrome and ICANS: grading and management","route":"/terms/lymphoma-tx-crs-icans/"},{"id":"lymphoma-tx-hepatitis-b-reactivation","kind":"term","name":"Hepatitis B reactivation before rituximab and other anti-CD20 antibodies","route":"/terms/lymphoma-tx-hepatitis-b-reactivation/"},{"id":"icans","kind":"term","name":"ICANS (neurotoxicity)","route":"/terms/icans/"},{"id":"lymphoma-tx-immunoglobulin-replacement","kind":"term","name":"Immunoglobulin replacement after CAR-T, bispecifics and long anti-CD20 treatment","route":"/terms/lymphoma-tx-immunoglobulin-replacement/"},{"id":"lymphoma-tx-pod24","kind":"term","name":"POD24: progression of follicular lymphoma within two years, and why it changes the plan","route":"/terms/lymphoma-tx-pod24/"},{"id":"step-up-dosing","kind":"term","name":"Step-up dosing (T-cell engagers)","route":"/terms/step-up-dosing/"},{"id":"lymphoma-tx-uk-access","kind":"term","name":"What the NHS in England funds for lymphoma, appraisal by appraisal","route":"/terms/lymphoma-tx-uk-access/"}],"trial":[{"id":"nct06508658","kind":"trial","name":"A Study of Subcutaneously Injected Epcoritamab Plus Oral Lenalidomide Tablets Compared to Intravenously (IV) Infused Rituximab Plus IV Infused Gemcita","route":"/trials/nct06508658/"},{"id":"nct06090539","kind":"trial","name":"A Study to Assess BMS-986458 Alone and in Combination With Anti-lymphoma Agents in Relapsed/Refractory Non-Hodgkin Lymphomas","route":"/trials/nct06090539/"},{"id":"nct05201248","kind":"trial","name":"A Study to Evaluate Adverse Events and Change in Disease Activity of Subcutaneous (SC) Epcoritamab As Monotherapy or Combined With Standard of Care Th","route":"/trials/nct05201248/"},{"id":"nct05283720","kind":"trial","name":"A Study to Evaluate Adverse Events and Change in Disease Activity of Subcutaneous (SC) Epcoritamab in Combination With Oral and Intravenous Anti-Neopl","route":"/trials/nct05283720/"},{"id":"nct05451810","kind":"trial","name":"A Study to Evaluate Adverse Events of Subcutaneous (SC) Epcoritamab Administered in the Outpatient Setting in Adult Participants With Relapsed or Refr","route":"/trials/nct05451810/"},{"id":"nct07226752","kind":"trial","name":"A Sub-study Trial of Epcoritamab vs Investigator's Choice Chemotherapy in Relapsed/Refractory Diffuse Large B-cell Lymphoma (R/R DLBCL) in China","route":"/trials/nct07226752/"},{"id":"epcore-dlbcl-1","kind":"trial","name":"EPCORE DLBCL-1","route":"/trials/epcore-dlbcl-1/"},{"id":"epcore-dlbcl-2","kind":"trial","name":"EPCORE DLBCL-2","route":"/trials/epcore-dlbcl-2/"},{"id":"epcore-nhl-1","kind":"trial","name":"EPCORE NHL-1","route":"/trials/epcore-nhl-1/"},{"id":"nct04623541","kind":"trial","name":"Safety and Efficacy Study of Epcoritamab in Subjects With Relapsed/Refractory Chronic Lymphocytic Leukemia and Richter's Syndrome","route":"/trials/nct04623541/"},{"id":"nct06191744","kind":"trial","name":"Study of Subcutaneous Epcoritamab in Combination With Intravenous Rituximab and Oral Lenalidomide (R2) to Assess Adverse Events and Change in Disease ","route":"/trials/nct06191744/"},{"id":"nct05409066","kind":"trial","name":"Study of Subcutaneous Epcoritamab in Combination With Intravenous Rituximab and Oral Lenalidomide (R2) to Assess Adverse Events and Change in Disease ","route":"/trials/nct05409066/"},{"id":"nct04542824","kind":"trial","name":"Trial of the Safety and Efficacy of Epcoritamab in Japanese Subjects With Relapsed or Refractory (R/R) B-Cell Non-Hodgkin Lymphoma (R/R B-NHL)","route":"/trials/nct04542824/"}],"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/"},{"id":"idea-bispecific-vs-car-t-second-line","kind":"idea","name":"Head-to-head bispecific vs CAR-T in second-line LBCL","route":"/ideas/idea-bispecific-vs-car-t-second-line/"}],"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/"}],"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 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