AbbVie reveals revised outcomes from the EPCORE NHL-6 trial, assessing the possibility of home surveillance for patients with persistent and treatment-resistant Diffuse Large B-Cell Lymphoma using Epcoritamab.
In a significant development for the treatment of relapsed/refractory diffuse large B-cell lymphoma (DLBCL), AbbVie, a global biopharmaceutical company, has presented updated results from its Phase 2 EPCORE® NHL-6 study. The study evaluates the potential for outpatient monitoring of patients receiving the first full dose of epcoritamab monotherapy.
Epcoritamab, an IgG1-bispecific antibody created using Genmab's proprietary DuoBody technology, is administered subcutaneously. It is designed to simultaneously bind to CD3 on T cells and CD20 on B cells, inducing T-cell-mediated killing of CD20+ cells.
The study, published in 2025, showed promising results. In patients treated with epcoritamab following two or more lines of systemic therapy, the overall response rate (ORR) was 60.0%, with a complete response (CR) rate of 38.0%, and a median follow-up of 10.8 months. In patients treated after only one prior line of systemic therapy, the ORR was 64.3% and the CR rate was 47.6%, at a median follow-up of 5.8 months.
However, healthcare providers will monitor patients for symptoms of Cytokine Release Syndrome (CRS), neurologic problems, infections, and low blood cell counts during treatment with epcoritamab. Common severe abnormal laboratory test results include decreased white blood cells, decreased red blood cells, and decreased platelets. CRS events occurred in 37 (40.2%) of patients, were primarily low grade (Grade 1-2), all resolved with a median time of two days, and no events led to treatment discontinuation.
Infections may lead to death and should be monitored by healthcare providers. Symptoms of infection may include fever, cough, chest pain, tiredness, shortness of breath, painful rash, sore throat, pain during urination, or feeling weak or generally unwell. If a female patient can become pregnant, a pregnancy test will be done before starting treatment with epcoritamab, and effective birth control should be used during treatment and for 4 months after the last dose.
Before receiving EPKINLY, patients should tell their healthcare provider about all medical conditions, including if they are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed. EPKINLY is not recommended for use during pregnancy or while breastfeeding.
The most common side effects of EPKINLY in DLBCL or high-grade B-cell lymphoma include CRS, tiredness, muscle and bone pain, injection site reactions, fever, stomach-area (abdominal) pain, nausea, and diarrhea. In follicular lymphoma, the most common side effects include injection site reactions, CRS, COVID-19, tiredness, upper respiratory tract infections, muscle and bone pain, rash, diarrhea, fever, cough, and headache.
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. The company operates in several key therapeutic areas including immunology, oncology, neuroscience, and eye care, as well as products and services in its Allergan Aesthetics portfolio.
The EPCORE NHL-6 trial is evaluating the safety of outpatient administration of subcutaneous epcoritamab as monotherapy in adult patients with R/R DLBCL. Epcoritamab is currently approved for R/R DLBCL after two or more prior lines of systemic therapy and is being investigated for use in earlier lines of therapy.
AbbVie is evaluating over 35 investigational medicines in multiple clinical trials for a wide range of blood cancers and solid tumors. More information about AbbVie and its oncology program can be found on its website. Patients are encouraged to report side effects to the FDA or Genmab US, Inc. The use of epcoritamab in an outpatient setting for the first full dose in R/R DLBCL and as monotherapy in DLBCL in the second-line setting has not been approved by the U.S. FDA or any other Health Authority.
