OnCo
drugsProductApproved2023🇪🇺🇬🇧🇯🇵🇦🇺

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.

Schematic of the modality · Bispecific T-cell engager (CD20×CD3) · not a molecule; see the T-cell engagers (bispecific) page
How it works, step by step · animated schematic, not to scale
T-cell engagers (bispecific)
Mechanism, step by step
auto-advancing · hover to pause

1.Subcutaneous injection; slow absorption blunts cytokine peaks

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.
Brand / code
Epkinly
Dosing & schedule
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.

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.

Cancer Drugs FundNICE TA954 · 2024SMC: accepted
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.

Regulatory

2top
  1. 19 May 2023ApprovalUS

    Accelerated approval in DLBCL (EPCORE NHL-1)

  2. 16 Jan 2026Filing / dealUS

    EPCORE DLBCL-1 topline: PFS met, OS (US primary endpoint) not met source

Approvals

RegionYearIndication
US2023Relapsed/refractory DLBCL or high-grade B-cell lymphoma after ≥2 lines (accelerated)
US2024Relapsed/refractory follicular lymphoma after ≥2 lines (accelerated; full 2025 with R2)

Safety

4top
Toxicity profile
Adverse eventAny gradeGrade 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

top
ClinicalTrials.gov · phase 2/3
refreshed 2026-09-09
50 studies28 recruiting44 Phase 26 Phase 3
Search “Epcoritamab” on ClinicalTrials.gov →
Counts are from a name search and may include unrelated studies; up to 100 studies are summarised.

Recruiting now (live from ClinicalTrials.gov)

Recruiting trials near you · live from ClinicalTrials.gov
Epcoritamab
intervention: Epcoritamab
Open on ClinicalTrials.gov →

Country and place are remembered in this browser only. A postcode is sent to OpenStreetMap's Nominatim service to find coordinates when you press the button; nothing else leaves your device.

Landmark trials in OnCo

Key papers

1top

Latest papers

top
Literature trend81 papers in the last 12 months+47% vs prior 12How this is computed
Latest papers · live from Europe PMC
Open in Europe PMC

Query 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.

Connected

16top

Pages like this

not linked directly; found by shared links