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EPCORE DLBCL-1 — Epcoritamab (CD3xCD20 bispecific) monotherapy vs investigator's choice chemoimmunotherapy, relapsed/refractory DLBCL (2L+)

Abstract: TBD · Session: Oral Abstract Session — Hematologic Malignancies: Lymphoma and Chronic Lymphocytic Leukemia (first full-results presentation), ASCO 2026 · Presenter: Not yet captured in available reporting · Embargo: May 2026

At a glance

  • Sponsor: Genmab (co-developed with AbbVie)
  • PI / presenter: Not captured in available reporting
  • NCT ID: NCT04628494
  • Phase: 3
  • Design: Global, open-label, multicenter, randomized — epcoritamab monotherapy vs investigator's choice chemoimmunotherapy (R-GemOx or bendamustine + rituximab [BR])
  • N: 483 patients
  • Primary endpoint(s): Progression-free survival (PFS)
  • Comparator: Investigator's choice chemoimmunotherapy (R-GemOx or BR)
  • Indication: Relapsed/refractory diffuse large B-cell lymphoma (DLBCL), ineligible for high-dose chemotherapy + autologous stem cell transplant
  • Line: Second-line and beyond (≥1 prior line; 73% had ≥2 prior lines)

Headline result

EPCORE DLBCL-1 is the first phase 3 study of a CD3xCD20 T-cell–engaging bispecific monotherapy to improve PFS over chemoimmunotherapy in R/R DLBCL. Epcoritamab improved PFS versus investigator's choice chemotherapy (HR 0.74; 95% CI, 0.60–0.92 — per Genmab/AbbVie topline, Jan 16, 2026). Improvements were also reported in complete response rate, duration of response, and time to next treatment. Overall survival favored epcoritamab numerically but was not statistically significant (HR 0.96; 95% CI, 0.77–1.20 — per topline, Jan 16, 2026). The global trial randomized 483 patients ineligible for high-dose chemotherapy and autologous stem cell transplant, 73% of whom had received ≥2 prior lines. (Full presented per-arm medians, CR rates, ORR, and DoR not yet captured from indexed ASCO 2026 reporting.)

Mechanism / class

Epcoritamab (Epkinly/Tepkinly; DuoBody CD3xCD20) is a subcutaneous bispecific antibody that engages CD3 on T cells and CD20 on malignant B cells to drive T-cell–mediated killing. It is already FDA-approved as monotherapy for R/R DLBCL after ≥2 prior lines (accelerated approval based on EPCORE NHL-1). EPCORE DLBCL-1 is the confirmatory randomized phase 3 intended to convert that accelerated approval and broaden use into earlier R/R lines.

Practice-changing?

Pending. As the first positive randomized phase 3 of a bispecific monotherapy beating chemoimmunotherapy on PFS in R/R DLBCL, it strengthens the case for off-the-shelf epcoritamab in transplant-ineligible patients and supports conversion of the accelerated approval. However, the lack of an OS benefit (HR 0.96) tempers the signal and will be central to discussant and regulatory framing; adoption likely awaits the full presented dataset and regulatory action.

Sources

  • ASCO Meeting Library: https://meetings.asco.org/abstracts-presentations/
  • Genmab — "Genmab to Highlight Advances Across Its Oncology Portfolio at the 2026 ASCO Annual Meeting and EHA 2026" (confirms first full-results oral presentation): https://www.stocktitan.net/news/GMAB/genmab-to-highlight-advances-across-its-oncology-portfolio-at-the-d1g2bkdbnn64.html
  • OncLive Rapid Readout — Phase 3 EPCORE DLBCL-1: https://www.onclive.com/view/phase-3-trial-epcore-dlbcl-1-of-epcoritamab-versus-standard-of-care-in-patients-with-relapsed-or-refractory-diffuse-large-b-cell-lymphoma-dlbcl-
  • OncLive — Epcoritamab Shows PFS, OS Benefits Over Chemotherapy in R/R DLBCL: https://www.onclive.com/view/epcoritamab-shows-pfs-os-benefits-over-chemotherapy-in-r-r-dbcl
  • CancerNetwork — Epcoritamab Enhances PFS vs SOC in R/R DLBCL: https://www.cancernetwork.com/view/epcoritamab-enhances-progression-free-survival-vs-soc-in-r-r-dlbcl
  • AbbVie topline (Jan 16, 2026): https://news.abbvie.com/2026-01-16-AbbVie-Announces-Topline-Results-for-Epcoritamab-DuoBody-R-CD3xCD20-from-Phase-3-EPCORE-R-DLBCL-1-Trial-in-Patients-with-Relapsed-Refractory-Diffuse-Large-B-cell-Lymphoma-DLBCL
  • Genmab topline (BusinessWire, Jan 16, 2026): https://www.businesswire.com/news/home/20260116529103/en/
  • ClinicalTrials.gov NCT04628494: https://clinicaltrials.gov/study/NCT04628494