• Based on the topline results from the EPCORE^® DLBCL-1 trial, AbbVie along with partner Genmab will engage global regulatory authorities to discuss next steps

AbbVie announced topline results from the Phase 3 EPCORE^® DLBCL-1 trial evaluating epcoritamab, a T-cell engaging bispecific antibody administered subcutaneously, compared to investigator's choice of chemoimmunotherapy in adult patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL). The study demonstrated an improvement in progression-free survival (PFS) (HR: 0.74 [95% CI 0.60 to 0.92])*. Improvements were observed in complete response rates (CRR), duration of response (DoR), and time to next treatment among patients treated with epcoritamab. The study did not demonstrate a statistically significant improvement in overall survival (OS) (HR: 0.96 [95% CI 0.77 to 1.20]).

EPCORE DLBCL-1 is the first Phase 3 study to demonstrate improvement in PFS in patients with R/R DLBCL who were treated with a CD3xCD20 T-cell engaging bispecific monotherapy. The global study enrolled 483 patients with R/R DLBCL with at least one prior line of therapy (73% had received two or more prior lines) who were ineligible for high-dose chemotherapy and autologous stem cell transplant (HDT-ASCT).

The adverse events observed in this study appear consistent with known safety of epcoritamab. AbbVie and Genmab are working to assess the potential impact of various factors, including the COVID-19 pandemic (trial conducted at the peak of the Omicron variant and prior to the widespread availability of vaccines) and the increased availability of novel anti-lymphoma therapies during the study timeline. The data will be submitted for presentation at a future medical meeting, and AbbVie and Genmab will engage global regulatory authorities to determine next steps.

DLBCL is the most common type of non-Hodgkin lymphoma (NHL) worldwide, accounting for approximately 25-30% of all NHL cases.^1,2 In the U.S., there are approximately 25,000 new cases of DLBCL diagnosed each year.³ DLBCL can arise in lymph nodes as well as in organs outside of the lymphatic system, occurs more commonly in the elderly and is slightly more prevalent in men.^4,5 DLBCL is a fast-growing type of NHL, a cancer that develops in the lymphatic system and affects B-cell lymphocytes, a type of white blood cell. For many people living with DLBCL, their cancer either relapses, which means it may return after treatment, or becomes refractory, meaning it does not respond to treatment. Although new therapies have become available, management can still be challenging.^4,6

Epcoritamab (EPKINLY^® in the U.S. and Japan and TEPKINLY^® in the EU) has received regulatory approval in certain lymphoma indications in more than 65 countries. AbbVie and Genmab remain committed to advancing epcoritamab, with ongoing clinical programs evaluating the therapy as a monotherapy and in combination regimens across treatment lines and a broad range of hematologic malignancies.