EPKINLY (epcoritamab) Approved by Japan Ministry of Health, Labour and Welfare as the First Bispecific Antibody to Treat Adults Patients with Certain Types of Relapsed or Refractory (R/R) Large B-Cell Lymphoma (LBCL) - Seite 2

“This approval marks an important milestone for patients in Japan with relapsed/refractory large B-cell lymphoma who are in need of alternative therapeutic options and who may now have access to EPKINLY, the first approved T-cell engaging bispecific antibody,” said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. “We are working closely with AbbVie to deliver EPKINLY to patients in Japan as quickly as possible and we remain committed to continue evaluating epcoritamab as a potential core therapy across B-cell malignancies.”

About the EPCORE NHL-3 Trial
EPCORE NHL-3 is an open-label, multi-center safety and preliminary efficacy trial of epcoritamab including a phase 1 first-in-human, dose escalation part; and a phase 2 expansion part. The trial was designed to evaluate subcutaneous epcoritamab in Japanese patients with relapsed, progressive or refractory mature B-NHL, including DLBCL. In the phase 2 expansion part, additional patients are treated with epcoritamab to further explore the safety and efficacy of epcoritamab in patients with R/R DLBCL and R/R FL who had limited therapeutic options.

In the study, 56 percent of the patients had primary refractory disease and 81 percent of patients were refractory to their last therapy. The median number of prior therapies was three (range: 2 to 8), with 44 percent of patients receiving two prior therapies, 25 percent receiving three prior therapies, and 31 percent receiving four or more prior therapies. Nineteen percent had prior autologous stem cell transplantation (ASCT), no one had prior chimeric antigen receptor (CAR) T-cell therapy.

About the EPCORE NHL-1 Trial
EPCORE NHL-1 is an open-label, multi-center safety and preliminary efficacy trial of epcoritamab that includes a phase 1 first-in-human, dose escalation part; a phase 2a expansion part; and a dose optimization part. The trial was designed to evaluate subcutaneous epcoritamab in patients with relapsed, progressive or refractory CD20+ mature B-cell NHL, including large B-cell lymphoma (LBCL) and DLBCL.ⁱⁱⁱ Data from the dose escalation part of the study, which determined the recommended phase 2 dose, were published in September 2021.^iv In the phase 2 expansion part, additional patients were treated with epcoritamab to further explore the safety and efficacy of epcoritamab in three cohorts of patients with different types of relapsed/refractory B-cell NHLs who had limited therapeutic options.ⁱⁱⁱ