OnCo
trialsTrialPositive

EPCORE NHL-1

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.

ORR 63.1%, CR 38.9%; median DOR 15.5 months; 3-year follow-up: 53% of complete responders in ongoing remission, many with undetectable ctDNA. CRS 49.7% (grade 3: 2.5%).

Setting
R/R LBCL after ≥2 lines (single-arm expansion): epcoritamab monotherapy
Phase
Phase 2
Sponsor
Genmab / AbbVie
Registry
NCT03625037
Headline result
ORR 63%, CR 39%.
Reported
2022
Enrolled
157

Outcomes

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In plain words
What these results mean for people, not percentages
157 people took part
Objective response rateprimaryresponse endpoint
  • 63.1 out of 100 people had their tumour shrink with Epcoritamab.
Complete response rateresponse endpoint
  • 38.9 out of 100 people had their tumour shrink with Epcoritamab.
Be careful
  • There was no comparison group, so this number cannot tell you how much of the effect is due to the treatment.
  • A response rate counts how many people had their tumours shrink by a set amount; shrinking is encouraging but does not by itself show that people live longer or feel better.
  • These results apply to the people the trial enrolled: R/R LBCL after ≥2 lines (single-arm expansion): epcoritamab monotherapy. People in a different situation may not see the same effect.

Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.

157 participants enrolled.

Objective response rateprimary
Epcoritamab63.1 of 100
n = 157
Source
Complete response rate
Epcoritamab38.9 of 100
n = 157
EndpointArmnValueHR (95% CI)pSource
Objective response rateprimaryEpcoritamab15763.1%——link
Complete response rateEpcoritamab15738.9%———

Key papers

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translationalJournal of Clinical Oncology 2023changed practice
EPCORE NHL-1: epcoritamab, a subcutaneous CD20 x CD3 bispecific, in relapsed large B-cell lymphoma including after CAR-T

CD20 x CD3 bispecifics gave patients whose lymphoma has failed CAR-T, or who cannot access it, an effective off-the-shelf treatment that can be started within days. Epcoritamab and glofitamab are now standard third-line options and are moving into earlier lines and combinations. They do not yet replace CAR-T, whose remissions appear more durable.

Connected

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Pages like this

not linked directly; found by shared links

cancers

1
Diffuse large B-cell lymphoma

drugs

1
ApprovedBispecific T-cell engager (CD20×CD3)
Epcoritamab · Epkinly

terms

2
Cytokine release syndrome (CRS)Objective response rate (ORR)

key papers

1
EPCORE NHL-1: epcoritamab, a subcutaneous CD20 x CD3 bispecific, in relapsed large B-cell lymphoma including after CAR-T