# Epcoritamab

Source: https://onco.cc/drugs/epcoritamab/  
OnCo record `epcoritamab` (Treatment). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

## Fields

- Kind: Treatment
- Status: approved
- Last checked: 2026-09-07
- 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: US 2023: Relapsed/refractory DLBCL or high-grade B-cell lymphoma after ≥2 lines (accelerated); US 2024: Relapsed/refractory follicular lymphoma after ≥2 lines (accelerated; full 2025 with R2); EU 2023: EU brand Tepkinly
- Dosing: Subcutaneous; 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
- Toxicity (grade 3+): Cytokine release syndrome 2.5%; ICANS 0.6%; Neutropenia 14.6%; Infections 14.6%

## Sources

- Wikipedia: https://en.wikipedia.org/wiki/Epcoritamab
- FDA label (DailyMed): https://dailymed.nlm.nih.gov/dailymed/search.cfm?query=Epcoritamab

## Connected records

- cancers: [Diffuse large B-cell lymphoma](https://onco.cc/cancers/dlbcl/), [Follicular lymphoma](https://onco.cc/cancers/follicular-lymphoma/), [HIV-associated (AIDS-related) lymphomas](https://onco.cc/cancers/hiv-associated-lymphoma/), [Non-Hodgkin lymphoma (all types)](https://onco.cc/cancers/non-hodgkin-lymphoma/), [Post-transplant lymphoproliferative disorder (PTLD)](https://onco.cc/cancers/post-transplant-lymphoproliferative-disorder/), [Primary mediastinal (thymic) large B-cell lymphoma](https://onco.cc/cancers/primary-mediastinal-b-cell-lymphoma/)
- technologies: [T-cell engagers (bispecific)](https://onco.cc/technologies/t-cell-engager/)
- targets: [CD20](https://onco.cc/targets/cd20/), [CD3](https://onco.cc/targets/cd3/)
- companies: [AbbVie (incl. ImmunoGen, Capstan)](https://onco.cc/companies/abbvie/), [Genmab](https://onco.cc/companies/genmab/)
- terms: [CD20 bispecific antibodies: step-up dosing, fixed duration and what it is like to take one](https://onco.cc/terms/lymphoma-tx-bispecific-step-up/), [Cytokine release syndrome (CRS)](https://onco.cc/terms/crs/), [Cytokine release syndrome and ICANS: grading and management](https://onco.cc/terms/lymphoma-tx-crs-icans/), [Hepatitis B reactivation before rituximab and other anti-CD20 antibodies](https://onco.cc/terms/lymphoma-tx-hepatitis-b-reactivation/), [ICANS (neurotoxicity)](https://onco.cc/terms/icans/), [Immunoglobulin replacement after CAR-T, bispecifics and long anti-CD20 treatment](https://onco.cc/terms/lymphoma-tx-immunoglobulin-replacement/), [POD24: progression of follicular lymphoma within two years, and why it changes the plan](https://onco.cc/terms/lymphoma-tx-pod24/), [Step-up dosing (T-cell engagers)](https://onco.cc/terms/step-up-dosing/), [What the NHS in England funds for lymphoma, appraisal by appraisal](https://onco.cc/terms/lymphoma-tx-uk-access/)
- trials: [A Study of Subcutaneously Injected Epcoritamab Plus Oral Lenalidomide Tablets Compared to Intravenously (IV) Infused Rituximab Plus IV Infused Gemcita](https://onco.cc/trials/nct06508658/), [A Study to Assess BMS-986458 Alone and in Combination With Anti-lymphoma Agents in Relapsed/Refractory Non-Hodgkin Lymphomas](https://onco.cc/trials/nct06090539/), [A Study to Evaluate Adverse Events and Change in Disease Activity of Subcutaneous (SC) Epcoritamab As Monotherapy or Combined With Standard of Care Th](https://onco.cc/trials/nct05201248/), [A Study to Evaluate Adverse Events and Change in Disease Activity of Subcutaneous (SC) Epcoritamab in Combination With Oral and Intravenous Anti-Neopl](https://onco.cc/trials/nct05283720/), [A Study to Evaluate Adverse Events of Subcutaneous (SC) Epcoritamab Administered in the Outpatient Setting in Adult Participants With Relapsed or Refr](https://onco.cc/trials/nct05451810/), [A Sub-study Trial of Epcoritamab vs Investigator's Choice Chemotherapy in Relapsed/Refractory Diffuse Large B-cell Lymphoma (R/R DLBCL) in China](https://onco.cc/trials/nct07226752/), [EPCORE DLBCL-1](https://onco.cc/trials/epcore-dlbcl-1/), [EPCORE DLBCL-2](https://onco.cc/trials/epcore-dlbcl-2/), [EPCORE NHL-1](https://onco.cc/trials/epcore-nhl-1/), [Safety and Efficacy Study of Epcoritamab in Subjects With Relapsed/Refractory Chronic Lymphocytic Leukemia and Richter's Syndrome](https://onco.cc/trials/nct04623541/), [Study of Subcutaneous Epcoritamab in Combination With Intravenous Rituximab and Oral Lenalidomide (R2) to Assess Adverse Events and Change in Disease ](https://onco.cc/trials/nct06191744/), [Study of Subcutaneous Epcoritamab in Combination With Intravenous Rituximab and Oral Lenalidomide (R2) to Assess Adverse Events and Change in Disease ](https://onco.cc/trials/nct05409066/), [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)](https://onco.cc/trials/nct04542824/)
- ideas: [ctDNA-guided escalation and de-escalation in frontline DLBCL](https://onco.cc/ideas/idea-ctdna-guided-dlbcl-frontline/), [Head-to-head bispecific vs CAR-T in second-line LBCL](https://onco.cc/ideas/idea-bispecific-vs-car-t-second-line/)
- roadmaps: [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](https://onco.cc/roadmaps/lymphoma-roadmap/)
- key papers: [EPCORE NHL-1: epcoritamab, a subcutaneous CD20 x CD3 bispecific, in relapsed large B-cell lymphoma including after CAR-T](https://onco.cc/key-papers/paper-epcore-nhl-1-epcoritamab-jco-2023/)
- biomarkers: [CD20 expression (CD20-positive)](https://onco.cc/biomarkers/cd20-expression/)

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