Epcoritamab
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.
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.
1.Subcutaneous injection; slow absorption blunts cytokine peaks
- 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: www.epkinly.com. Doses are for orientation; the current label governs.
- Medicare
- Part B (clinician-administered)
Given by infusion or injection in a clinic or hospital outpatient department, so it is a Part B drug: Medicare pays 80% after the Part B deductible and the patient owes 20% coinsurance, uncapped in Original Medicare unless a Medigap policy applies. Step-up dosing is often started in hospital (Part A) because of cytokine release syndrome monitoring, then continued in the outpatient setting. Subcutaneous, clinician-administered.
- Commercial insurance
- covered with prior authorisation
Covered under the medical benefit with prior authorisation confirming diagnosis, biomarker status and line of therapy; site-of-care policies may steer infusions away from hospital outpatient departments.
- Assistance programmes
- myAbbVie Assist
- PAN Foundation — Disease-specific co-pay and premium funds; open and closed funds change monthly.
- HealthWell Foundation
- CancerCare Co-Payment Assistance Foundation
- Patient Advocate Foundation Co-Pay Relief
- Leukemia & Lymphoma Society financial support
20% Part B coinsurance on a high-cost infusion adds up quickly: Medigap Plan G or N, Medicare Advantage maximum out-of-pocket, Medicaid dual eligibility, or a charity fund are the usual buffers.
Sources: Medicare.gov: Chemotherapy · Medicare.gov: Prescription drugs (outpatient, Part B). Not medical or financial advice; verify with your plan.
- Appraised for
- Relapsed or refractory DLBCL after 2 or more systemic treatments
- Cancer Drugs Fund
- Entered the Cancer Drugs Fund under a managed access agreement; check the current CDF list for whether it has since moved to routine commissioning.
- NHS England
- Routinely funded for the appraised indication (or via managed access)
Sources: NICE TA954 · NHS England Cancer Drugs Fund list · SMC advice: epcoritamab. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
- 19 May 2023ApprovalUS
Accelerated approval in DLBCL (EPCORE NHL-1)
- 16 Jan 2026Filing / dealUS
EPCORE DLBCL-1 topline: PFS met, OS (US primary endpoint) not met source
Approvals
| Region | Year | Indication |
|---|---|---|
| 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) |
| Adverse event | Any grade | Grade 3+ |
|---|---|---|
| Cytokine release syndrome | 49.7% | 2.5% |
| ICANS | 6.4% | 0.6% |
| Neutropenia | — | 14.6% |
| Infections | — | 14.6% |
EPCORE NHL-1 DLBCL cohort. Events listed without rates were not read from a primary source; see the label. Blank cells mean the figure was not sourced, not that it is zero.
Trials
topRecruiting now (live from ClinicalTrials.gov)
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Landmark trials in OnCo
Latest papers
topQuery for this drug: (TITLE:"Epcoritamab" OR ABSTRACT:"Epcoritamab" OR TITLE:"Epkinly" OR ABSTRACT:"Epkinly") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Epcoritamab, not a curated reading list.
Pages like this
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Shares Head-to-head bispecific vs CAR-T in second-line LBCL, Step-up dosing (T-cell engagers), EPCORE NHL-1: epcoritamab, a subcutaneous CD20 x CD3 bispecific, in relapsed large B-cell lymphoma including after CAR-T, CD20.
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Shares EPCORE NHL-1: epcoritamab, a subcutaneous CD20 x CD3 bispecific, in relapsed large B-cell lymphoma including after CAR-T, CD20, CD3, Follicular lymphoma.
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Shares EPCORE NHL-1: epcoritamab, a subcutaneous CD20 x CD3 bispecific, in relapsed large B-cell lymphoma including after CAR-T, CD20, CD3, Follicular lymphoma.
- ProductLisocabtagene maraleucel
Shares ICANS (neurotoxicity), Follicular lymphoma, Cytokine release syndrome (CRS), Diffuse large B-cell lymphoma.
- TrialSTARGLO
Shares EPCORE NHL-1: epcoritamab, a subcutaneous CD20 x CD3 bispecific, in relapsed large B-cell lymphoma including after CAR-T, T-cell engagers (bispecific), Diffuse large B-cell lymphoma.
- InstitutionComprehensive Cancer Center Mainfranken, University Hospital Würzburg
Shares ICANS (neurotoxicity), Cytokine release syndrome (CRS), T-cell engagers (bispecific), Diffuse large B-cell lymphoma.
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Shares ICANS (neurotoxicity), Follicular lymphoma, Cytokine release syndrome (CRS), Diffuse large B-cell lymphoma.