On September 3, 2025 Genmab A/S (Nasdaq: GMAB) reported updated results from the Phase 2 EPCORE NHL-6 trial (NCT05451810) evaluating the safety and efficacy of investigational epcoritamab, a T-cell engaging bispecific antibody administered subcutaneously, as a monotherapy administered in the outpatient setting in adult patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) who have received at least one prior line of systemic therapy, including at least one anti-CD20 monoclonal antibody-containing therapy (Press release, Genmab, SEP 3, 2025, View Source [SID1234655728]). The study demonstrated the feasibility of treating and monitoring patients in an outpatient setting following the first dose of epcoritamab and showed that the incidence and severity of adverse events associated with epcoritamab were consistent with previous epcoritamab studies in patients with R/R DLBCL. These results were shared today during a poster presentation (Abstract #ABCL-1224) at the 13th Society of Hematologic Oncology (SOHO) Annual Meeting.
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In the study, 88 patients received the first full dose (48 mg) of epcoritamab monotherapy. Of these, 81 patients (92%) received the first full dose in the outpatient setting and seven (8%) in the inpatient setting. Among the 81 treated and monitored as outpatients, 57 (70%) did not experience cytokine release syndrome (CRS) during the first full dose period. CRS occurred with the first full dose in 24 (30%) patients (21 patients in the outpatient setting; three patients in the inpatient setting, admitted for reasons unrelated to CRS), all Grade 1–2 events, with 10 (12%) patients managed in the outpatient setting, and 11 (13.6%) requiring inpatient care. Overall, CRS events occurred in 37 (40.2%) patients in the entire trial period, were primarily low grade (Grade 1-2), all resolved with a median time of two days, and no events led to treatment discontinuation. Immune cell-associated neurotoxicity syndrome (ICANS) occurred in seven patients (7.6%), were primarily low grade (Grade 1-2), all resolved with a median time of three days, and no events led to treatment discontinuation.
"The EPCORE NHL-6 trial results are notable, as current bispecific antibody treatments for relapsed and refractory diffuse large B-cell lymphoma patients may require in-hospital monitoring for cytokine release syndrome after certain initial doses and as needed after subsequent doses," said Jeff Sharman, M.D., Disease Chair, Hematology Research, Sarah Cannon Research Institute (SCRI) at Willamette Valley Cancer Institute in Eugene, Oregon. "The possibility of treating patients in the outpatient setting is encouraging and it may enable more people to have access to this treatment option across various sites of care, including community settings."
The study also demonstrated an overall response rate (ORR) of 64.3% and a complete response (CR) rate of 47.6%, at a median follow up of 5.8 months in patients (n=42) treated with epcoritamab after only one prior line of systemic therapy. In patients treated with epcoritamab following two or more lines of systemic therapy (n=50), with a median follow up of 10.8 months, the study showed an ORR of 60.0% and a CR rate of 38.0%.
"Together with our partner AbbVie, we remain committed to advancing research that supports people living blood cancer no matter where they are in their treatment journey and developing epcoritamab as a potential core therapy across B-cell malignancies," said Dr. Judith Klimovsky, Executive Vice President and Chief Development Officer at Genmab.
The safety and efficacy of investigational epcoritamab for use in the outpatient setting for first full dose in R/R DLBCL in the second-line setting has not been approved by US FDA or any other Health Authority.
About Diffuse Large B-Cell Lymphoma
DLBCL is the most common type of non-Hodgkin lymphoma (NHL) worldwide, accounting for approximately 25-30 percent 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 become refractory, meaning it does not respond to treatment. Although new therapies have become available, treatment management can remain a challenge.
About the EPCORE NHL-6 Trial
EPCORE NHL-6 is a Phase 2 open-label clinical trial evaluating the safety of outpatient administration of subcutaneous epcoritamab monotherapy in adult patients with relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL). The primary objective of the trial was to assess adverse events within three months of treatment initiation with epcoritamab monotherapy. The primary outcome measures were percentage of participants experiencing Grade 3 or higher cytokine release syndrome (CRS) events, immune cell-associated neurotoxicity syndrome (ICANS) events and/or neurotoxicity (Ntox) events. Secondary outcomes included responses to treatment. The study was conducted across community and academic sites in the U.S.
EPCORE NHL-6 enrolled 92 patients with R/R DLBCL who had received at least one prior line of systemic therapy, including at least one anti-CD20 monoclonal antibody-containing therapy. At the time of data cutoff (January 15, 2025), 92 patients had received one or more dose of epcoritamab, the median follow-up was 7.6 months (range, 6.0-9.2), and half of patients remained on treatment. Median age was 69 years, 82.6 percent had Ann Arbor stage III-IV. 24 percent had prior CAR T, 24 percent had bulky disease ≥7cm, and 51 percent had International Prognostic Index (IPI) ≥3. Of note 42 of patients had 1 prior line of therapy. More information can be found at View Source (NCT05451810).