Genmab Announces European Commission Approval of TEPKINLY (epcoritamab) for Adults with Relapsed or Refractory (R/R) Diffuse Large B-cell Lymphoma (DLBCL)

Genmab A/S (Nasdaq: GMAB) announced today that the European Commission (EC) has granted conditional marketing authorization for TEPKINLY (epcoritamab) as a monotherapy for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy. TEPKINLY is the first and only subcutaneous T-cell engaging bispecific antibody approved for the treatment of this patient population in the European Union (EU), as well as Liechtenstein, Norway and Iceland.

DLBCL is the most common type of B-cell non-Hodgkin’s lymphoma worldwide. While patients may have access to chemoimmunotherapy regimens to treat their disease, they face limited treatment options, with few readily available, off-the-shelf medicines, especially for those whose disease has relapsed or become refractory to prior treatments.ⁱ

“With TEPKINLY, people in Europe living with relapsed or refractory diffuse large B-cell lymphoma who are in need of additional treatment options now have a readily available, innovative therapeutic option for this aggressive cancer,” said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. “Today’s approval underscores our commitment to bringing our bispecific antibody to more patients worldwide. We’re excited to continue working with our partner AbbVie to further explore epcoritamab as potential core therapy across B-cell malignancies.”

This conditional approval is supported by data from the pivotal EPCORE NHL-1 phase 1/2 open-label, multi-cohort, multi-center, single-arm trial evaluating the preliminary efficacy and safety of TEPKINLY in patients with R/R large B-cell lymphoma (LBCL), including its subtype DLBCL. In this study, DLBCL patients treated with TEPKINLY (n=139) achieved an overall response rate of 62 percent (n=86) and a complete response rate of 39 percent (n=54), with a median duration of response of 15.5 months (range: 9.7, not reached).

Results from the trial showed that TEPKINLY demonstrated a manageable safety profile across the LBCL patient cohort (n=167), which included the DLBCL patient population. The most common adverse reactions (≥ 20 percent) were cytokine release syndrome, fatigue, neutropenia, injection site reaction, musculoskeletal pain, abdominal pain, pyrexia, nausea and diarrhea.

“Relapsed or refractory DLBCL is an aggressive cancer and patients can face a difficult and emotional treatment journey. At this point in the journey, a patient may have had multiple lines of therapy and will already have experienced relapse,” said Anna Sureda, M.D., Ph.D., head of clinical hematology department, Institut Català d’Oncologia – L’Hospitalet, Barcelona, Spain. “This European Commission approval represents an important moment for the DLBCL patient community and brings with it a potential opportunity for effective disease management for a condition with limited available treatment options.”