Genmab has reported new outcomes from the Phase Ib/II EPCORE NHL-2 trial Arm 10 of T-cell engaging bispecific antibody, epcoritamab, in conjunction with rituximab, ifosfamide, carboplatin, and etoposide (R-ICE) in those with relapsed/refractory diffuse large B-cell lymphoma (r/r DLBCL).
The patients involved in the trial are eligible for autologous stem cell transplantation (ASCT).
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The open-label, interventional trial aimed at assessing the tolerability, safety, pharmacodynamics/biomarkers, pharmacokinetics, preliminary efficacy, and immunogenicity of epcoritamab as a single agent and in conjunction with other standard of care agents in individuals with B-cell non-Hodgkin’s lymphoma (B-NHL).
It comprises two parts, dose escalation and dose expansion.
The main aim of the first and second parts is safety and preliminary efficacy, respectively.
Overall response rate (ORR) was the primary goal, based on the best overall response as per Lugano criteria. MRD negativity was evaluated as a secondary goal.
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By GlobalDataArm 10 of the trial enrolled 31 subjects, with a median follow-up of 11 months, and 65% had advanced within 12 months of first-line treatment.
The combination therapy demonstrated an ORR of 87%, with a complete response (CR) rate of 65% and a partial response (PR) rate of 23%.
At six months, 81% of responses were ongoing, 74% of subjects remained progression-free, and all patients were alive.
These findings were presented at the 30th European Hematology Association (EHA) 2025 Congress.
The safety profile of the combo demonstrated low-grade cytokine release syndrome (CRS) without any discontinuations due to treatment-emergent adverse events (TEAEs).
Additionally, no clinical tumour lysis syndrome was identified.
The combo showed an 85% ORR and 55% CR in the subjects who progressed within 12 months post-first-line treatment, while those who progressed after 12 months experienced a 91% and 82% ORR and CR, respectively.
Those with one previous line of therapy had an 88% ORR and 68% CR, and those with over one previous line had an 83% ORR and 50% CR.
Developed using Genmab’s DuoBody technology, epcoritamab is an immunoglobulin G1 (IgG1)-bispecific antibody that is administered subcutaneously.
Genmab chief development officer and executive vice-president Dr Judith Klimovsky said: “The results from this trial highlight the potential of this investigational epcoritamab containing regimen, especially in patients who progress quickly after initial treatment, and reinforce our joint efforts with AbbVie to develop epcoritamab as a core therapy for B-cell lymphomas, especially as we develop epcoritamab in earlier lines of therapy and a broader patient population.”
Recently, Genmab’s antibody drug conjugate (ADC) rinatabart sesutecan (Rina-S) has shown positive efficacy in treating patients with endometrial cancer.
