Epkinly Improves Progression-Free Survival in Relapsed/Refractory DLBCL

Results from the phase 3 EPCORE DLBCL-1 clinical trial show that patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who received Epkinly (epcoritamab) monotherapy experienced a significant improvement in progression-free survival, according to a news release from Genmab A/S.

This global study focused on patients who had already received at least one prior line of therapy and were not eligible for high-dose chemotherapy or a stem cell transplant, providing a potential new treatment option for those whose cancer has returned or stopped responding to standard treatments.

Main Data from the Epkinly Clinical Trial

The topline results from the trial revealed that Epkinly, a T-cell engaging bispecific antibody, reduced the risk of the cancer worsening or death by 26% compared to standard chemotherapy. This marks the first time a phase 3 study has demonstrated an improvement in progression-free survival using a CD3xCD20 T-cell engaging bispecific monotherapy for this specific patient population.

In addition to the primary finding of improved progression-free survival, researchers observed several other benefits for patients treated with Epkinly. These included higher rates of complete response, which is the total disappearance of all signs of cancer in response to treatment. The study also showed an improvement in the duration of response — how long the cancer remains in check — and an increase in the time to next treatment, meaning patients could wait longer before needing to start a new therapeutic regimen.

Epkinly Trial details

The EPCORE DLBCL-1 trial is a global, multi-center, randomized phase 3 study that began on Jan. 13, 2021. It enrolled 483 patients living with DLBCL, the most common type of non-Hodgkin lymphoma. DLBCL is a fast-growing cancer that affects B-cell lymphocytes, a type of white blood cell. It is particularly challenging to manage when it is relapsed (returns after treatment) or refractory (does not respond to initial treatment).

Of the 483 participants, 73% had already received two or more prior lines of therapy. All participants were considered ineligible for high-dose chemotherapy and autologous stem cell transplant (HDT-ASCT), which are often the standard treatments for younger or healthier patients with relapsed disease.

The trial compared Epkinly, which is administered as an injection under the skin (subcutaneously), against the investigator’s choice of two common chemotherapy regimens: Rituxan (rituximab) plus gemcitabine and oxaliplatin (R-GemOx) or bendamustine plus Rituxan (BR)

Epkinly works by using DuoBody technology to simultaneously bind to two different targets: CD3 on T cells (part of the immune system) and CD20 on B cells (where the cancer is located). This action is designed to direct the body’s own T cells to find and eliminate the cancerous B cells.

Safety of Treatment with Epkinly

According to the announcement, the adverse events recorded during the EPCORE DLBCL-1 trial were consistent with what is already known about the safety profile of Epkinly. No new or unexpected safety concerns were reported during this phase 3 evaluation.

The researchers noted that further analysis of the data is currently ongoing. This includes looking at how external factors, such as the COVID-19 pandemic and the increasing availability of other new lymphoma therapies, may have influenced the trial outcomes.

Full results from the study are expected to be presented at an upcoming medical meeting. In the meantime, the trial remains ongoing as Genmab and AbbVie prepare to discuss these findings with global regulatory authorities to determine the next steps for the treatment.

Additional data are also expected later in 2026 from two other phase 3 trials, EPCORE DLBCL-2 and EPCORE DLBCL-4, which are looking at how Epkinly performs when used earlier in treatment or in combination with other medications.

Editor's note: This article is for informational purposes only and is not a substitute for professional medical advice, as your own experience will be unique. Use this article to guide discussions with your oncologist. Content was generated with AI, reviewed by a human editor, but not independently verified by a medical professional.

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