# EPCORE NHL-1

Source: https://onco.cc/trials/epcore-nhl-1/  
OnCo record `epcore-nhl-1` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-07
- Registry id: NCT03625037
- Phase: 1/2
- Setting: R/R LBCL after ≥2 lines (single-arm expansion): epcoritamab monotherapy
- Sponsor: Genmab / AbbVie
- Enrolled: 157
- Result: ORR 63%, CR 39%.
- Outcomes: Objective response rate: Epcoritamab 63.1%; Complete response rate: Epcoritamab 38.9%

## Sources

- ClinicalTrials.gov NCT03625037: https://clinicaltrials.gov/study/NCT03625037

## Connected records

- 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/)
- trials: [POLARGO](https://onco.cc/trials/polargo/), [STARGLO](https://onco.cc/trials/starglo/)
- cancers: [Diffuse large B-cell lymphoma](https://onco.cc/cancers/dlbcl/)
- technologies: [T-cell engagers (bispecific)](https://onco.cc/technologies/t-cell-engager/)
- drugs: [Epcoritamab](https://onco.cc/drugs/epcoritamab/)
- companies: [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/), [Objective response rate (ORR)](https://onco.cc/terms/orr/)
- people: [Catherine Thieblemont](https://onco.cc/people/catherine-thieblemont/)
- ideas: [ctDNA-guided escalation and de-escalation in frontline DLBCL](https://onco.cc/ideas/idea-ctdna-guided-dlbcl-frontline/)
- 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/)

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