AbbVie Shares Promising Phase 3 Data for Epcoritamab in DLBCL Patients

AbbVie, in conjunction with its partner Genmab, has recently announced the topline results from the Phase 3 EPCORE® DLBCL-1 trial. This clinical trial focused on the effectiveness of epcoritamab, a bispecific antibody designed to engage T cells, in treating adult patients suffering from relapsed or refractory diffuse large B-cell lymphoma (DLBCL). In this pivotal study, the results demonstrated noteworthy improvements in progression-free survival (PFS), with a hazard ratio of 0.74, suggesting that patients receiving epcoritamab experienced a longer duration without disease progression compared to those undergoing standard chemotherapy.

The trial enrolled a total of 483 participants who had previously undergone at least one line of therapy, with a significant portion (73%) having received two or more lines. Notably, the study highlighted improvements in several response metrics such as complete response rates (CRR) and duration of response (DoR). However, the trial did not demonstrate a statistically significant enhancement in overall survival (OS).

This Phase 3 trial stands out as the first to show improved PFS among patients treated with a CD3xCD20 bispecific monotherapy specifically targeting those with R/R DLBCL. The design of the trial facilitated subcutaneous administration of epcoritamab, presenting a more convenient administration route for patients compared to traditional intravenous options.

While the adverse events reported during the trial aligned with the known safety profile of epcoritamab, AbbVie and Genmab are evaluating the potential effects of external factors, including the COVID-19 pandemic on participant outcomes, as the trial occurred during the peak of the Omicron variant outbreak when vaccine availability was limited. As part of their commitment to bringing epcoritamab to market, AbbVie and Genmab will engage with global regulatory authorities to discuss the forthcoming procedural steps based on the trial findings.

DLBCL accounts for 25-30% of all non-Hodgkin lymphoma cases globally, with approximately 25,000 new diagnoses in the U.S. each year. The disease tends to be more aggressive and prevalent in older adults and men. For many affected individuals, the disease may relapse following initial therapies or prove resistant to treatment, making advancements in treatment options crucial.

Epcoritamab, marketed as EPKINLY® in the U.S. and Japan, and TEPKINLY® in the EU, has garnered regulatory approval in over 65 countries for certain lymphoma indications. Recognizing its potential, AbbVie and Genmab are concurrently conducting studies to further evaluate the efficacy of epcoritamab in various hematologic malignancies, either as a standalone treatment or in combination therapies.

With these promising results in hand, the path forward for epcoritamab appears more hopeful. The drug highlights the continuous efforts of AbbVie and Genmab to enhance patient care by delivering innovative treatment solutions that address difficult-to-treat cancers. Further presentations of the EPCORE DLBCL-1 trial findings are anticipated at future medical conferences, offering the oncology community insights into the potential of epcoritamab in clinical practice.

For ongoing updates or more detailed information on this trial, interested parties can visit ClinicalTrials.gov.

In conclusion, the topline results from the EPCORE DLBCL-1 trial underscore AbbVie's dedication to developing transformative therapies for patients facing the challenges of relapsed or refractory DLBCL, reinforcing their position as leaders in oncology innovation.