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)

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 for 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.

“Diffuse large B-cell lymphoma is an aggressive and often treatment-resistant disease with limited therapeutic options for patients whose disease is refractory or who have experienced relapse after multiple lines of therapy,” said Catherine Thieblemont, M.D., Ph.D., head of the hemato-oncology department, Paris University, Hôpital Saint-Louis Assistance-Publique-Hopitaux de Paris (APHP) in Paris. “Subcutaneous epcoritamab could become a promising treatment option for the DLBCL community, and I look forward to the European Commission’s final decision.”

DLBCL is an aggressive type of cancer that develops in the lymphatic system. It is the most common type of B-cell NHL worldwide and accounts for approximately 30 percent of all global cases. Because NHL affects B-cell lymphocytes, the disease and its subtypes, including DLBCL, are classified as B-cell malignancies.ⁱⁱ