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

A Phase 3 trial (NCT07226752) investigating epcoritamab for participants with relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL) in China is scheduled to reach primary completion on 2025-10-13. This sub-study trial compares epcoritamab against investigator's choice chemotherapy in this patient population.

Background

The trial, titled "A Sub-study Trial of Epcoritamab vs Investigator's Choice Chemotherapy in Relapsed/Refractory Diffuse Large B-cell Lymphoma (R/R DLBCL) in China," aims to evaluate the safety and efficacy of epcoritamab, also known as EPKINLY™ and GEN3013. It is designed for participants with DLBCL that is not responding to treatment, has grown in size, or has come back following treatment with at least 1 prior systemic cancer therapy.

Trial design

The study (NCT07226752) is a Phase 3 trial with an enrollment of 72 participants. It is investigating treatment for individuals diagnosed with Diffuse Large B-Cell Lymphoma. Participants are randomly assigned to receive either epcoritamab or a pre-specified investigator's choice (standard of care) chemotherapy, which includes either rituximab + gemcitabine + oxaliplatin (R-GemOx) or bendamustine + rituximab (BR).

What this means

The scheduled primary completion of this Phase 3 trial marks a significant milestone in the evaluation of epcoritamab for relapsed/refractory diffuse large B-cell lymphoma in the Chinese population. Upon completion, the collected data will be analyzed to assess the comparative safety and efficacy of epcoritamab against established chemotherapy regimens. These findings will be crucial for understanding the potential role of epcoritamab as a treatment option for patients who have exhausted other systemic therapies.

Source

Information regarding the primary completion of this trial was obtained from ClinicalTrials.gov, a public database of clinical studies. The update for study NCT07226752, titled "A Sub-study Trial of Epcoritamab vs Investigator's Choice Chemotherapy in Relapsed/Refractory Diffuse Large B-cell Lymphoma (R/R DLBCL) in China," indicates a scheduled primary completion date of 2025-10-13 on clinicaltrials.gov.