Topline Findings
- Outpatient Treatment Potential: Epkinly may allow safe administration of relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) therapy in outpatient settings, improving patient access and convenience.
- Strong Efficacy Across Lines of Therapy: Epkinly demonstrates meaningful overall and complete response rates in patients with R/R DLBCL after one or more prior therapies.
- Manageable Safety Profile: Cytokine release syndrome (CRS) and immune cell-associated neurotoxicity syndrome (ICANS) were predominantly low-grade and resolved quickly, supporting outpatient feasibility.
Results from the Phase II EPCORE NHL-6 trial showed that Genmab’s and AbbVie’s Epkinly (epcoritamab) demonstrated encouraging efficacy in patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) who have received at least one prior line of systemic therapy.
According to the company, the trial highlights the potential for administering Epkinly in an outpatient setting, which could broaden access to treatment and offer a more convenient and flexible approach to managing R/R DLBCL.1
How Can Epkinly Improve Patient Adherence?
"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, MD, disease chair, hematology research, Sarah Cannon Research Institute at Willamette Valley Cancer Institute, Eugene, OR, in a press release. "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."
EPCORE NHL-6 Trial Design and Endpoints
- The open-label EPCORE NHL-6 trial evaluated Epkinly monotherapy in approximately 184 patients with R/R DLBCL.
- The primary endpoint of the trial was to assess adverse events within three months of treatment initiation.
- Primary outcome measures included the percentage of participants experiencing grade 3 or higher cytokine release syndrome (CRS) events, immune cell-associated neurotoxicity syndrome (ICANS) events, and/or neurotoxicity events.
- Key secondary endpoints included responses to treatment as determined by investigators using Lugano 2014 criteria.1,2
Key Results
- Among 88 patients receiving the first full 48 mg dose, most were monitored in the outpatient setting.
- Results showed that Epkinly demonstrated an overall response rate (ORR) of 64.3% and complete response (CR) of 47.6% in patients treated after one prior therapy, and an ORR of 60% and CR of 38% in those treated after two or more prior therapies.
- CRS occurred in 40.2% of patients, while ICANS occurred in 7.6% of patients.
- Most cases of CRS and ICANS were low-grade events that resolved within a median of two to three days without causing treatment discontinuation.1
Unmet Needs in the Treatment of DLBCL
- AbbVie notes that DLBCL is the most prevalent form of non-Hodgkin lymphoma (NHL) globally, representing roughly one-quarter to one-third of all NHL cases.
- In the United States, around 25,000 people are diagnosed with DLBCL annually.1
- According to the American Cancer Society, NHL is among the most common cancers in the United States, accounting for 4% of all cancers.
- Notably, NHL is one of the most common cancers in children, adolescents, and young adults. However, the prevalence increases with age, with more than half of cases being diagnosed in patients aged 65 years or older.
- From 2013 to 2022, the death rate of NHL decreased by around 2% each year.3
Future Implications for the Treatment of R/R DLBCL
"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,” said Svetlana Kobina, MD, PhD, VP, oncology medical affairs, AbbVie, in the press release. “This potential shift to outpatient care could help improve access to treatment. 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."
References
- AbbVie Announces Updated Results From Phase 2 EPCORE® NHL-6 Study Evaluating the Potential for Outpatient Monitoring of Epcoritamab in Patients With Relapsed/Refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL). AbbVie. September 3, 2025. Accessed September 4, 2025. https://news.abbvie.com/2025-09-03-AbbVie-Announces-Updated-Results-From-Phase-2-EPCORE-R-NHL-6-Study-Evaluating-the-Potential-for-Outpatient-Monitoring-of-Epcoritamab-in-Patients-With-Relapsed-Refractory-R-R-Diffuse-Large-B-Cell-Lymphoma-DLBCL
- A Study to Evaluate Adverse Events of Subcutaneous (SC) Epcoritamab Administered in the Outpatient Setting in Adult Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma and Classic Follicular Lymphoma. Clinicaltrials.gov. Accessed September 4, 2025. https://clinicaltrials.gov/study/NCT05451810
- Key Statistics for Non-Hodgkin Lymphoma. American Cancer Society. Accessed September 4, 2025. https://www.cancer.org/cancer/types/non-hodgkin-lymphoma/about/key-statistics.html
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