Epcoritamab Phase 3 Trial for R/R DLBCL Reaches Primary Completion

The Phase 3 trial (NCT04628494) investigating epcoritamab (also known as EPKINLY™ and GEN3013) in participants with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) reached its primary completion on October 13, 2025. This milestone signifies that data collection for the study's primary endpoint has concluded, moving the trial closer to potential analysis and reporting of results.

Background

Epcoritamab is being evaluated as a treatment for participants with diffuse large B-cell lymphoma (DLBCL) who have not responded to prior treatments, experienced disease progression, or relapsed after at least one previous systemic cancer therapy. The trial aims to assess its safety and efficacy in this challenging patient population, where treatment options for relapsed/refractory disease can be limited.

Trial design

The trial, identified as NCT04628494, is a Phase 3 study with an overall status of ACTIVE_NOT_RECRUITING. It enrolled 484 participants diagnosed with Diffuse Large B-cell Lymphoma. Participants were randomly assigned to receive either epcoritamab or a pre-specified investigator's choice standard of care chemotherapy. The comparator chemotherapy options included rituximab + gemcitabine + oxaliplatin (R-GemOx) or bendamustine + rituximab (BR). The primary purpose of this trial is to determine if epcoritamab is safe and effective compared to these standard chemotherapy regimens in participants with R/R DLBCL who have failed or are ineligible for at least one prior systemic cancer therapy.

What this means

The primary completion of this Phase 3 trial for epcoritamab in R/R DLBCL is a crucial step in its development. It indicates that all necessary data for the primary outcome measure has been collected, paving the way for data analysis and the eventual reporting of results. These findings will be critical for understanding the potential role of epcoritamab as a new therapeutic option for patients with this aggressive form of lymphoma, particularly those who have exhausted other treatment avenues.

Source

Information regarding the primary completion of this trial was sourced from ClinicalTrials.gov, a public database of clinical studies. The update for study NCT04628494, titled "A Phase 3 Trial of Epcoritamab vs Investigator's Choice Chemotherapy in Relapsed/Refractory (R/R) Diffuse Large B-cell Lymphoma (DLBCL)," was noted with a primary completion date of October 13, 2025 on clinicaltrials.gov.