Epkinly Demonstrates Encouraging Efficacy in Part II Trial for Relapsed or Refractory Diffuse Massive B-Cell Lymphoma

Outcomes from the Part II EPCORE NHL-6 trial confirmed that Genmab’s and AbbVie’s Epkinly (epcoritamab) demonstrated encouraging efficacy in sufferers with relapsed or refractory (R/R) diffuse giant B-cell lymphoma (DLBCL) who’ve acquired at the least one prior line of systemic remedy.

In accordance with the corporate, the trial highlights the potential for administering Epkinly in an outpatient setting, which might broaden entry to therapy and provide a extra handy and versatile strategy to managing R/R DLBCL.¹

“The EPCORE NHL-6 trial outcomes are notable, as present bispecific antibody therapies for relapsed and refractory diffuse giant B-cell lymphoma sufferers might require in-hospital monitoring for cytokine launch syndrome after sure preliminary doses and as wanted after subsequent doses,” stated Jeff Sharman, MD, illness chair, hematology analysis, Sarah Cannon Analysis Institute at Willamette Valley Most cancers Institute, Eugene, OR, in a press launch. “The opportunity of treating sufferers within the outpatient setting is encouraging, and it could allow extra individuals to have entry to this therapy choice throughout numerous websites of care, together with neighborhood settings.”

EPCORE NHL-6 Trial Design and Endpoints

• The open-label EPCORE NHL-6 trial evaluated Epkinly monotherapy in roughly 184 sufferers with R/R DLBCL.
• The first endpoint of the trial was to evaluate antagonistic occasions inside three months of therapy initiation.
• Major final result measures included the proportion of individuals experiencing grade 3 or greater cytokine launch syndrome (CRS) occasions, immune cell-associated neurotoxicity syndrome (ICANS) occasions, and/or neurotoxicity occasions.
• Key secondary endpoints included responses to therapy as decided by investigators utilizing Lugano 2014 standards.^1,2

Key Outcomes

• Amongst 88 sufferers receiving the primary full 48 mg dose, most have been monitored within the outpatient setting.
• Outcomes confirmed that Epkinly demonstrated an total response charge (ORR) of 64.3% and full response (CR) of 47.6% in sufferers handled after one prior remedy, and an ORR of 60% and CR of 38% in these handled after two or extra prior therapies.
• CRS occurred in 40.2% of sufferers, whereas ICANS occurred in 7.6% of sufferers.
• Most circumstances of CRS and ICANS have been low-grade occasions that resolved inside a median of two to 3 days with out inflicting therapy discontinuation.¹

Unmet Wants within the Remedy of DLBCL

• AbbVie notes that DLBCL is probably the most prevalent type of non-Hodgkin lymphoma (NHL) globally, representing roughly one-quarter to one-third of all NHL circumstances.
• In america, round 25,000 individuals are identified with DLBCL yearly.1
• In accordance with the American Most cancers Society, NHL is among the many commonest cancers in america, accounting for 4% of all cancers.
• Notably, NHL is likely one of the commonest cancers in kids, adolescents, and younger adults. Nonetheless, the prevalence will increase with age, with greater than half of circumstances being identified in sufferers aged 65 years or older.
• From 2013 to 2022, the loss of life charge of NHL decreased by round 2% every year.3

• Future Implications for the Remedy of R/R DLBCL

“The up to date EPCORE NHL-6 trial findings offered on the Society of Hematologic Oncology Annual Assembly recommend that therapy of relapsed/refractory diffuse giant B-cell lymphoma with epcoritamab may be protected within the outpatient setting,” stated Svetlana Kobina, MD, PhD, VP, oncology medical affairs, AbbVie, within the press launch. “This potential shift to outpatient care might assist enhance entry to therapy. AbbVie stays dedicated to constructing on our management in blood most cancers, which incorporates advancing analysis with our associate Genmab, that firmly establishes the influence of investigational epcoritamab in successive traces of therapy throughout B-cell malignancies.”

References

1. AbbVie Publicizes Up to date Outcomes From Part 2 EPCORE® NHL-6 Research Evaluating the Potential for Outpatient Monitoring of Epcoritamab in Sufferers With Relapsed/Refractory (R/R) Diffuse Massive B-Cell Lymphoma (DLBCL). AbbVie. September 3, 2025. Accessed September 4, 2025. https://information.abbvie.com/2025-09-03-AbbVie-Publicizes-Up to date-Outcomes-From-Part-2-EPCORE-R-NHL-6-Research-Evaluating-the-Potential-for-Outpatient-Monitoring-of-Epcoritamab-in-Sufferers-With-Relapsed-Refractory-R-R-Diffuse-Massive-B-Cell-Lymphoma-DLBCL
2. A Research to Consider Antagonistic Occasions of Subcutaneous (SC) Epcoritamab Administered within the Outpatient Setting in Grownup Members With Relapsed or Refractory Diffuse Massive B-Cell Lymphoma and Basic Follicular Lymphoma. Clinicaltrials.gov. Accessed September 4, 2025. https://clinicaltrials.gov/examine/NCT05451810
3. Key Statistics for Non-Hodgkin Lymphoma. American Most cancers Society. Accessed September 4, 2025. https://www.most cancers.org/most cancers/sorts/non-hodgkin-lymphoma/about/key-statistics.html