Genmab Announces AbbVie Receives Positive CHMP Opinion for Epcoritamab (TEPKINLY) for the Treatment of Adults with Relapsed/Refractory (R/R) Diffuse Large B-cell Lymphoma (DLBCL)

Company Announcement

• The positive CHMP opinion is supported by results from the EPCORE NHL-1 phase 1/2 trial evaluating the preliminary efficacy and safety of epcoritamab in patients with non-Hodgkin’s lymphoma (NHL), including diffuse large B-cell lymphoma (DLBCL)
• DLBCL is an aggressive subtype of NHL and accounts for approximately 30 percent of all global cases
• If approved, epcoritamab (TEPKINLY) would become the first and only subcutaneous bispecific antibody conditionally approved as a monotherapy in the European Union for the treatment of adult patients with relapsed or refractory (R/R) DLBCL after two or more lines of systemic therapy
  
  

COPENHAGEN, Denmark; July 21, 2023 – Genmab A/S (Nasdaq: GMAB) today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the granting of conditional marketing authorization of epcoritamab (TEPKINLY) 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. The final European Commission decision on the indication for epcoritamab is anticipated later this year.

“Today’s CHMP opinion is an important step forward in our mission to bringing innovative, readily available medicines like epcoritamab to patients in Europe who are in need of alternative treatment options for relapsed or refractory diffuse large B-cell lymphoma,” said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. “We look forward to continuing our work with AbbVie to develop epcoritamab as a potential core therapy across B-cell malignancies.”   

AbbVie’s application for the approval of epcoritamab is supported by results from the pivotal EPCORE NHL-1 phase 1/2 open-label, multi-center trial evaluating the safety and preliminary efficacy of epcoritamab in patients with relapsed, progressive or refractory CD20+ mature B-cell NHL, including DLBCL. The primary endpoint of the study was overall response rate, as assessed by an independent review committee (63.1 percent). The most common treatment-emergent adverse event was cytokine release syndrome.ⁱ Updated results were recently presented at multiple medical congresses.