Clinical trialLymphoma

Efficacy and safety of epcoritamab in relapsed or refractory large B-cell lymphoma: 3-year update from the EPCORE NHL-1 trial.

Ann Hematol · 2026The total number of patients is not stated in the abstract of this report (per the initial report: 157 patients); 119 patients evaluable for minimal residual disease (MRD)

Karimi YH, Cheah CY, Clausen MR, et al. Ann Hematol. 2026. 105:79

Study type: Clinical trial
Study name: EPCORE NHL-1
Design: Single-arm, open-label, multicentre study; 3-year follow-up report (median follow-up 37.1 months, data cut-off 3 May 2024)
Sample size: The total number of patients is not stated in the abstract of this report (per the initial report: 157 patients); 119 patients evaluable for minimal residual disease (MRD)
Source: Ann Hematol · 2026
Trial registration: NCT03625037

In plain words

This report gives the results of about three years of follow-up of patients whose large B-cell lymphoma had come back or not responded after several previous treatments (sometimes even after CAR T) and who received the drug epcoritamab; it is given under the skin and links the body's immune cells to lymphoma cells so that they destroy them. About six out of ten patients responded to treatment, and about four out of ten had a complete response. In those with a complete response, the disease often stayed under control for a long time (more than three years on average). The most common side effect was a reaction called cytokine release syndrome (fever and flu-like symptoms), and infections were also common.

Key results

59% / 41%

Overall response rate / complete response

Investigator-assessed; median follow-up 37.1 months

20.8 months

Median duration of response

95% CI 13.0 to 32.0

36.1 months

Median duration of complete response

20.2 to not reached; longest ongoing complete response more than 43 months

4.2 months in all patients; 37.3 months in patients with a complete response

Median progression-free survival

95% CI 2.8 to 5.5; 26.0 to not reached

18.5 months in all patients; not reached in patients with a complete response

Median overall survival

95% CI 11.7 to 27.7

54 of 119 patients (45%)

MRD negativity

At any time during the study

Dose and schedule cards

Single-agent epcoritamab

DLBCL or high-grade B-cell lymphoma, relapsed or refractory after at least 2 lines of systemic therapyCycle length: Every 28 daysOn the page “Lymphoma” · Treatment regimens and dosing: relapsed or refractory DLBCL, transplant-ineligible and later lines

DLBCL or high-grade B-cell lymphoma, relapsed or refractory after at least 2 lines of systemic therapy

Drug	Dose	Route	Schedule
Cycle 1
Epcoritamab	0.16 mg (Day 1), 0.8 mg (Day 8), 48 mg (Days 15 and 22)	SC	Days 1, 8, 15 and 22
Cycles 2 and 3
Epcoritamab	48 mg	SC	Days 1, 8, 15 and 22
Cycles 4–9
Epcoritamab	48 mg	SC	Days 1 and 15
Cycle 10 onward
Epcoritamab	48 mg	SC	Day 1

Cycle length: Every 28 days
Duration: Until disease progression or unacceptable toxicity

Per the FDA label for EPKINLY: in cycle 1, dexamethasone 15 mg (or prednisolone 100 mg) 30 to 120 minutes before each dose and for three days afterward, plus diphenhydramine and acetaminophen; Pneumocystis prophylaxis is mandatory and herpes prophylaxis is recommended; after the first 48 mg dose (cycle 1, Day 15), assess the need for hospitalisation or outpatient monitoring. CRS occurred in 51% of patients, mostly grade 1–2.

On the page “Lymphoma” · Treatment regimens and dosing: relapsed or refractory DLBCL, transplant-ineligible and later lines

Doses follow the trial protocol, guideline or official drug label (source given in the notes of each regimen). Before prescribing, check blood counts, renal and hepatic function, drug interactions and the patient’s condition, and adjust the dose according to the drug label.

Treatment arms and regimens

1Epcoritamab

Epcoritamab subcutaneously in 28-day cycles: step-up doses in cycle 1 (0.16 mg on day 1, 0.8 mg on day 8 and the first full dose of 48 mg on day 15), then 48 mg weekly to the end of cycle 3, every 2 weeks in cycles 4 to 9 and every 4 weeks from cycle 10 onwards, until disease progression or unacceptable toxicity.

Source of the regimen details: FDA label for EPKINLY (Dosage and Administration section for DLBCL); schedule from the initial EPCORE NHL-1 report

Doses are given for the information of specialists, as in this study’s protocol, and are not a prescription. Every drug must be prescribed by the treating physician for the individual patient.

Study population

Adults with relapsed or refractory large B-cell lymphoma (LBCL). Median age was 64.0 years; 39% had previously received CAR T therapy and 75% were refractory to two or more consecutive lines of therapy.

Endpoints

Primary endpoint: overall response rate (ORR).

Other reported outcomes: complete response, duration of response, duration of complete response, progression-free survival, overall survival, MRD negativity and safety.

Safety and side effects

Most common adverse events: cytokine release syndrome (51%), fatigue (25%) and pyrexia (25%); no new safety signal was seen. Grade 1, 2 and 3 infections occurred in 23%, 34% and 24% of patients, respectively.

Clinical significance and place in guidelines

This 3-year update shows that complete responses with epcoritamab in heavily pretreated relapsed or refractory LBCL are durable and that a subgroup of patients achieves long-term disease control. However, median progression-free survival in all patients is short (4.2 months), and the benefit is largely confined to patients with a complete response.

Limitations

The study is single-arm without a control group. Responses were reported by investigator assessment. Analysis by complete response (comparing patients with and without a complete response) is inherently biased and does not show a causal relationship.

Original article (DOI)PubMed ClinicalTrials.gov

This summary was prepared by the editorial team from the published paper; the original paper is the final reference. Read the original abstract on PubMed.