AbbVie (NYSE: ABBV), in collaboration with Genmab, announced topline results from its pivotal Phase 3 EPCORE® DLBCL-1 clinical trial. The study evaluated epcoritamab (DuoBody® CD3xCD20), a subcutaneously administered T-cell-engaging bispecific antibody, as a monotherapy for adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL).
The trial achieved a significant milestone, marking the first time a Phase 3 study has demonstrated an improvement in progression-free survival (PFS) for a CD3xCD20 T-cell engaging bispecific monotherapy in this specific patient population.
Key Trial Findings
The global, open-label, randomized trial compared epcoritamab against the investigator’s choice of standard chemoimmunotherapy (either R-GemOx or BR). The study enrolled 483 patients who were ineligible for high-dose chemotherapy and autologous stem cell transplant (HDT-ASCT).
- Progression-Free Survival (PFS): Patients treated with epcoritamab showed a statistically significant improvement in PFS compared to those receiving traditional chemoimmunotherapy, with a Hazard Ratio (HR) of 0.74 (95% CI 0.60 to 0.92).
- Secondary Endpoints: The trial also observed improvements in complete response rates (CRR), duration of response (DoR), and time to the next treatment.
- Overall Survival (OS): While the trial met its PFS goals, it did not reach statistical significance in overall survival (HR: 0.96 [95% CI 0.77 to 1.20]).
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Safety and Contextual Factors
The safety profile of epcoritamab in this trial remained consistent with previously reported data, with no new or unexpected safety signals. AbbVie and Genmab noted that several external factors may have influenced the data, including the timing of the trial during the peak of the COVID-19 Omicron variant and the rapid introduction of other novel anti-lymphoma therapies during the study period.
About DLBCL and Epcoritamab
Diffuse large B-cell lymphoma (DLBCL) is the most common form of non-Hodgkin lymphoma (NHL) globally, accounting for nearly 30% of all cases. It is an aggressive, fast-growing cancer. While frontline treatments are often successful, many patients eventually relapse or become refractory to treatment, making the management of the disease particularly challenging for those ineligible for stem cell transplants.
Epcoritamab is an IgG1-bispecific antibody designed to simultaneously bind to CD3 on T-cells and CD20 on B-cells, triggering T-cell-mediated killing of the cancerous B-cells. It is already approved under the brand names EPKINLY® (U.S. and Japan) and TEPKINLY® (EU) for certain lymphoma indications.
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Next Steps
AbbVie and Genmab plan to present the detailed results of the EPCORE DLBCL-1 trial at an upcoming medical meeting. The companies will also initiate discussions with global regulatory authorities to determine the next steps for seeking expanded indications for the therapy.
As part of their ongoing oncology collaboration, the two companies continue to investigate epcoritamab both as a monotherapy and in combination with other treatments across various hematologic malignancies.
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