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 bispespecific monotherapy.
The global study enrolled 483 patients with R/R DL BCL 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 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.
In the U.S., there are approximately 25,000 new cases of DLBCL diagnosed each year. 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. 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. The most common side effects of EPKINLY when used alone in DLBCL or high-grade B-cell lymphoma or FL include CRS, injection site reactions, tiredness, muscle and bone pain, fever, diarrhea, COVID-19, rash, and stomach-area (abdominal) pain. The most common severe abnormal laboratory test results with EPKINLY when used together with lenalidomide and rituximab in FL include rash, upper respiratory tract infections, tiredness, tiredness, injection site reactions, constipation, diarrhea, CRS, pneumonia, COVID-19, and fever.
The most common severe abnormal Laboratory test results with EPKINly when used together with lenalidOMide and rituxIMab include decreased white blood cells and decreased platelets. These are not all of the possible side effects of EPKINly. Call doctor for medical advice about side effects.
