The bispecific antibody received an accelerated approval in May to treat patients with R/R diffuse large B-cell lymphoma.
Results from the phase 1/2 EPCORE-NHL-1 clinical trial show that epcoritamab produced an 82% overall response rate (ORR) for patients with relapsed/refractory (R/R) follicular lymphoma (FL), who make up one cohort of patients in the study evaluating the T-cell engaging bispecific antibody.
Topline results for the FL cohort of the phase 1/2 EPCORE-NHL-1 trial (NCT03625037) were announced in statements from Genmab and AbbVie.
EPCORE-NHL-1 is an open-label multi-center study to evaluate safety and preliminary efficacy of epicoritamab for patients with multiple types of NHL. Phase 1 was the first-in-human dose escalation phase, with phase 2a featuring a dose expansion part and a dose optimization part.
The subcutaneous bispecific antibody that targets CD3 x CD20 is also being studied in high-grade B-cell lymphoma, mantle cell lymphoma, marginal zone lymphoma, small lymphocytic lymphoma, as well as other types of non-Hodgkin lymphoma (NHL).
Epcoritamab received an accelerated approval in May to treat patients who have been treated with 2 or more lines of systemic therapy for diffuse large B-cell lymphoma. It is being marketed as Epkinly.
These latest results cover 128 adult patients with R/R FL who received at least 2 lines of systemic therapy; 70.3% of the participants were double refractory to both an anti-CD20 monoclonal antibody and an alkylating agent.
Officials from Genmab and AbbVie reported that the median duration of response was not reached. No new safety signals were observed at the time of the analysis, with the most common treatment emergent adverse event being cytokine release syndrome (CRS), which was experienced by 66.4% of the FL patients (1.6% were above grade 2).
“These topline results are encouraging for relapsed or refractory follicular lymphoma patients who are in need of new therapeutic options,” said Jan van de Winkel, PhD, CEO of Genmab. “With our partner AbbVie, we are committed to evaluating epcoritamab as a potential core therapy across B-cell malignancies. We look forward to sharing the full results from this study cohort at an upcoming medical congress and discussing the results with global regulatory authorities.”
"We are encouraged by these topline results, which further support the clinical profile of epcoritamab as a potential therapeutic option for patients with relapsed or refractory follicular lymphoma," said Mariana Cota Stirner, MD, PhD, vice president, therapeutic area head for hematology, AbbVie, in a statement. "Together with our partner Genmab, these results may bring us one step closer to our goal of advancing a potential core therapy for patients with B-cell malignancies."
Statements from Genmab and AbbVie indicate the optimization part of phase 2a is continuing, as investigators evaluate the optimal step-up dosing regimens to manage CRS. Results will be presented at an upcoming medical congress, and the companies will work with regulatory agencies on the next steps.