3-Year EPCORE NHL-1 Data Published Showing 53% Have Deep, Durable Remission
•February 12, 2026
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Why It Matters
These results validate epcoritamab as a long‑term therapeutic option for relapsed/refractory LBCL, potentially reshaping treatment algorithms and expanding the bispecific antibody market.
Key Takeaways
- •53% of complete responders progression‑free at three years
- •Median complete response duration 36.1 months, longest over 43 months
- •Cytokine release syndrome occurred in 51%, mostly grade 1‑2
- •Phase 3 EPCORE DLBCL‑1 improved PFS by 26% versus chemo
- •Epcoritamab gained accelerated FDA approvals for DLBCL and FL
Pulse Analysis
Bispecific antibodies have emerged as a pivotal class in hematologic oncology, linking T‑cells to malignant B‑cells to trigger targeted cytotoxicity. Epcoritamab, a subcutaneous CD3×CD20 construct, received its first accelerated FDA approval for relapsed/refractory diffuse large B‑cell lymphoma (DLBCL) in 2023, followed by approval for follicular lymphoma in 2024. The drug’s mechanism—simultaneous engagement of CD3 on T‑cells and CD20 on tumor cells—offers an off‑the‑shelf alternative to autologous CAR‑T therapies, addressing manufacturing delays and accessibility concerns that have limited CAR‑T uptake.
The three‑year update from the EPCORE NHL‑1 trial underscores the durability of epcoritamab‑induced remissions. More than half of the complete responders remained progression‑free after three years, and median overall survival reached 18.5 months, with not‑reached survival for those in CR. Notably, 45% of evaluable patients achieved measurable residual disease negativity, suggesting deep molecular clearance. Safety signals stayed consistent; cytokine release syndrome affected just over half of participants, predominantly low‑grade, and infection rates aligned with expectations for heavily pre‑treated cohorts. These data provide compelling evidence that epcoritamab can sustain disease control even in patients refractory to multiple lines, including prior CAR‑T therapy.
From a commercial perspective, epcoritamab’s expanding label portfolio—now covering DLBCL, follicular lymphoma, and a frontline combination with lenalidomide and rituximab—positions it as a versatile asset in AbbVie’s oncology pipeline. The phase 3 EPCORE DLBCL‑1 trial’s 26% progression‑free survival improvement versus standard chemoimmunotherapy reinforces its competitive edge against other bispecifics and small‑molecule regimens. As payers evaluate cost‑effectiveness, the drug’s subcutaneous administration and manageable safety profile may drive broader adoption, potentially reshaping the standard of care for relapsed/refractory B‑cell malignancies.
3-Year EPCORE NHL-1 Data Published Showing 53% Have Deep, Durable Remission
Epcoritamab delivers lasting 3‑year remissions in relapsed large B‑cell lymphoma, with over half of complete responders staying progression‑free
In a trial that started with patients heavily pretreated for large B‑cell lymphoma (LBCL), more than half who achieved a complete response (CR) with the bispecific epcoritamab (Epkinly; Genmab/AbbVie) remained in remission at 3 years, and 63 % were still alive, according to results published early this month.¹
Long‑term data from the EPCORE NHL‑1 trial were published February 4 in the Annals of Hematology ¹. An earlier presentation of these data took place during the 66th American Society of Hematology Annual Meeting and Exposition in San Diego, California, in December 2024.²
Image: Epkinly packaging (Genmab)
Image: Epkinly (epcoritamab‑bysp) injection 4 mg/0.8 mL box and vial product image for subcutaneous injection after dilution by a healthcare provider only
Among patients in the trial who achieved a CR, 53 % remained in remission at the time of data cutoff, with the longest CR exceeding 43 months. This occurred despite the fact that 75 % of the patients were refractory to at least two lines of treatment and 39 % had already received chimeric antigen receptor (CAR) T‑cell therapy. In addition, of the 19 patients evaluable for measurable residual disease (MRD) assessment, 45 % achieved MRD negativity at some point during the study.¹
“An estimated 53 % of patients with a CR remained progression‑free at 3 years, and an estimated 75 % of patients with a CR had not initiated a new anti‑lymphoma therapy at 3 years,” investigators wrote.¹
EPCORE NHL‑1 (NCT03625037) is a multicohort, single‑arm, phase 1/2 trial conducted at 54 global sites. It evaluated epcoritamab, a subcutaneous CD3×CD20 bispecific antibody, in 157 patients with relapsed or refractory (R/R) CD20⁺ mature B‑cell non‑Hodgkin lymphoma; these included 139 patients with diffuse large B‑cell lymphoma (DLBCL). After a step‑up dosing schedule, treatment moved from every 2 weeks to every 4 weeks, and patients remained on epcoritamab until disease progression or unacceptable toxicity.¹
Data from EPCORE‑NHL‑1 led to the FDA’s accelerated approval of epcoritamab in R/R DLBCL in May 2023³; epcoritamab also received accelerated approval for R/R follicular lymphoma (FL) in June 2024⁴.
More recently, in November 2025, the FDA approved epcoritamab in combination with lenalidomide and rituximab (R²) to treat FL as early as the first relapse, based on results of the phase 3 EPCORE FL‑1 trial (NCT05409066)⁵.
According to the study authors, this extended durability suggests the potential for long‑term disease‑free survival for a subset of patients. “Prolonged CR and survival in complete responders, alongside sustained MRD negativity and a manageable safety profile, support epcoritamab monotherapy as an effective therapy with durable outcomes for patients with challenging‑to‑treat R/R LBCL,” they wrote.
Other results reported at the 3‑year mark
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Patients enrolled had a median age of 64.0 years; 60 % were male, 61 % had primary refractory disease, and 29 % had progressed within 6 months of prior CAR T‑cell therapy.
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The trial’s primary endpoint was overall response rate (ORR). At the 3‑year mark, the ORR was 59 %, with a CR rate of 41 %; both rates were maintained from prior analyses, “demonstrating the stability of treatment outcomes over time,” the investigators wrote.
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As of May 3 2024, median follow‑up was 37.1 months (range, 0.3–45.5). Median duration of response was 20.8 months (95 % CI, 13.0–32.0).
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Median duration of CR was 36.1 months (95 % CI, 20.2–not reached [NR]), “representing one of the longest median durations of complete response for approved bispecific antibodies in this patient population.”
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Median progression‑free survival for the overall study population was 4.2 months (95 % CI, 2.8–5.5); investigators reported that “most patients who remained on epcoritamab beyond 1 year of treatment remained progression‑free.”
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Among the 47 patients who responded for at least 1 year, 11 % had disease progression between 1 year and 2 years of treatment; of the remaining 29 who stayed on treatment beyond 2 years, 7 % had disease progression after 2 years.
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Median overall survival (OS) was 18.5 months (95 % CI, 11.7–27.7) for the overall population and was NR (95 % CI, 36.4–NR) for patients with a CR.
Safety
Long‑term safety results were consistent with previous reports. Cytokine release syndrome was the most common adverse event (AE), seen in 51 % of patients, with no new cases in the extended follow‑up. Cases occurred mostly during cycle 1 after the first full dose and were primarily low‑grade (grade 1, 32 %; grade 2, 16 %). Infections were seen in 57 % of patients, with grade 1 and 2 infections accounting for 23 % and 34 %, respectively.¹
COVID‑19 contributed to infection‑related AEs of grade 3 or higher, which were seen in 24 % of patients; rates were consistent (3 %–17 %) across 12‑week intervals up to week 144. Treatment‑emergent AEs led to discontinuation in 17 % of patients, with COVID‑19 being the most common reason. Deaths attributable to AEs occurred in 13 % of patients.¹
Other results
Epcoritamab is being further investigated as monotherapy and in combination with other treatments in several phase 3 trials. In January 2026, topline results for the phase 3 EPCORE DLBCL‑1 trial (NCT04628494) were reported by Genmab and AbbVie. EPCORE DLBCL‑1 involves patients with R/R DLBCL who were treated with subcutaneous epcoritamab versus investigator’s‑choice chemoimmunotherapy⁶.
The study showed a 26 % improvement in progression‑free survival (HR 0.74; 95 % CI, 0.60–0.92), with improvements seen in CR rates, duration of response, and time to next treatment among patients treated with epcoritamab. The trial did not demonstrate a statistically significant improvement in OS (HR 0.96; 95 % CI, 0.77–1.20).
References
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Karimi YH, Cheah CY, Clausen MR, et al. Efficacy and safety of epcoritamab in relapsed or refractory large B‑cell lymphoma: 3‑year update from the EPCORE NHL‑1 trial. Ann Hematol. 2026;105(3):79. doi:10.1007/s00277-026-06798-4
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Vose JM, Cheah CY, Clausen MR, et al. 3‑Year Update from the EPCORE NHL‑1 trial: epcoritamab leads to deep and durable responses in relapsed or refractory large B‑cell lymphoma. Blood. 2024;144(suppl 1):4480. doi:10.1182/blood-2024-198714
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Epkinly (epcoritamab‑bysp) approved by US FDA as the first and only bispecific antibody to treat adults with relapsed or refractory diffuse large B‑cell lymphoma (DLBCL). PRNewswire. May 19 2023. Accessed Feb 12 2026. https://bit.ly/3BGQt9j
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FDA grants accelerated approval to epcoritamab‑bysp for relapsed or refractory follicular lymphoma. FDA. June 26 2024. Accessed Jan 24 2025. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-epcoritamab-bysp-relapsed-or-refractory-follicular-lymphoma
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Falci L, Nijland M, Huang H, et al. Epcoritamab, lenalidomide, and rituximab versus lenalidomide and rituximab for relapsed or refractory follicular lymphoma (EPCORE FL‑1): a global, open‑label, randomised, phase 3 trial. Lancet. Published online Dec 7 2025. doi:10.1016/S0140-6736(25)02360-8
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Genmab announces topline results for epcoritamab (DuoBody® CD3×CD20) from phase 3 EPCORE® DLBCL‑1 trial in patients with relapsed/refractory diffuse large B‑cell lymphoma (DLBCL). Genmab news release. Jan 16 2026. Accessed Feb 12 2026. https://ir.genmab.com/news-releases/news-release-details/genmab-announces-topline-results-epcoritamab-duobodyr-cd3xcd20
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