AbbVie announced updated results from the phase 2 EPCORE NHL-6 trial (NCT05451810) evaluating the feasibility of dosing and monitoring patients in the outpatient setting for the first full dose of epcoritamab monotherapy, a T-cell engaging bispecific antibody administered subcutaneously, 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. Results from the study demonstrated that the incidence and severity of cytokine release syndrome (CRS) and immune cell-associated neurotoxicity syndrome (ICANS) following treatment with epcoritamab were consistent with previous epcoritamab studies in R/R DLBCL. These results were shared during a poster presentation (Abstract #ABCL-1224) at the 13th Society of Hematologic Oncology (SOHO) Annual Meeting.
In the study, 88 patients received the first full dose (48 mg) of epcoritamab monotherapy. Of these, 81 patients (92%) were monitored in the outpatient setting and seven (8%) in the inpatient setting. Overall, CRS events occurred in 37 (40.2%) of patients during the entire trial period (n=92), were primarily low grade (Grade 1-2), all resolved with a median time of two days, and no events led to treatment discontinuation. 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, haematology 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 showed 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%. Currently, epcoritamab is 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. See approved indication and important safety information below.
"The updated EPCORE NHL-6 trial findings presented at the Society of Hematologic Oncology Annual Meeting suggest that treatment of relapsed/refractory diffuse large B-cell lymphoma with epcoritamab can be safe in the outpatient setting. This potential shift to outpatient care could help improve access to treatment," said Svetlana Kobina, M.D., Ph.D, vice president, oncology medical affairs, AbbVie. "AbbVie remains committed to building on our leadership in blood cancer, which includes advancing research with our partner Genmab, that firmly establishes the impact of investigational epcoritamab in successive lines of treatment across B-cell malignancies."
DLBCL is the most common type of non-Hodgkin's lymphoma (NHL) worldwide, accounting for approximately 25-30% of all NHL cases. In the US, 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. Although new therapies have become available, management can still be challenging.
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 US FDA or any other Health Authority.
EPCORE NHL-6 is a phase 2 open-label clinical trial evaluating the safety of outpatient administration of subcutaneous epcoritamab as 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 the 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 as determined by Lugano 2014 criteria and assessed by investigators.
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 =1 dose of epcoritamab (community: n=41; academic: n=51). Median follow-up was 7.6 months (range, 6.0-9.2) and 50% remained on treatment. Median age was 69 years, 83% had Ann Arbor stage III-IV, 24% had prior CAR T, 24% had bulky disease =7cm, and 51% had International Prognostic Index (IPI) =3.
Epcoritamab is an IgG1-bispecific antibody created using Genmab's proprietary DuoBody technology and administered subcutaneously. Genmab's DuoBody-CD3 technology is designed to direct cytotoxic T cells selectively to elicit an immune response toward target cell types. Epcoritamab is designed to simultaneously bind to CD3 on T cells and CD20 on B cells and induces T-cell-mediated killing of CD20+ cells.7 Epcoritamab is being co-developed by Genmab and AbbVie as part of the companies' oncology collaboration. The companies share commercial responsibilities in the US and Japan, with AbbVie responsible for further global commercialization. Both companies will pursue additional international regulatory approvals for the investigational R/R FL indication and additional approvals for the R/R DLBCL indication.
Genmab and AbbVie continue to evaluate the use of epcoritamab as a monotherapy, and in combination, across lines of therapy in a range of hematologic malignancies. This includes five ongoing Phase 3, open-label, randomized trials including a trial evaluating epcoritamab as a monotherapy in patients with R/R DLBCL compared to investigators choice chemotherapy (NCT04628494), a trial evaluating epcoritamab in combination with R-CHOP in adult patients with newly diagnosed DLBCL (NCT05578976), a trial evaluating epcoritamab in combination with rituximab and lenalidomide (R2) in patients with R/R FL (NCT05409066), a trial evaluating epcoritamab in combination with rituximab and lenalidomide (R2) compared to chemoimmunotherapy in patients with previously untreated FL (NCT06191744), and a trial evaluating epcoritamab in combination with lenalidomide compared to chemotherapy infusion in patients with R/R DLBCL (NCT06508658). The safety and efficacy of epcoritamab have not been established for these investigational uses.
Epkinly is a prescription medicine used to treat adults with certain types of diffuse large B-cell lymphoma (DLBCL), high-grade B-cell lymphoma, or follicular lymphoma (FL) that has come back or that did not respond to previous treatment after receiving 2 or more treatments. Epkinly is approved based on patient response data. Studies are ongoing to confirm the clinical benefit of Epkinly. It is not known if Epkinly is safe and effective in children.
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