• Subcutaneous EPKINLY^TM (epcoritamab) is the first and only bispecific antibody approved in Japan to treat adult patients with certain types of relapsed/refractory (R/R) large B-cell lymphoma (LBCL) after two or more lines of systemic therapy
• Approval based on results of EPCORE^TM NHL-3 and EPCORE^TM NHL-1 clinical trials, evaluating EPKINLY in patients with certain types of R/R LBCL
• LBCL is a common form of non-Hodgkin’s lymphoma (NHL) and currently has limited treatment options, particularly in the R/R setting

“Despite recent advances in the treatment of LBCL, the prognosis for patients with relapsed/refractory LBCL remains generally poor, and there is a need for additional treatment options for patients whose condition has worsened after multiple lines of treatment,” said Koji Izutsu, MD, PhD, principal investigator of the phase 1/2 EPCORE NHL-3 trial in Japan and Head of the Hematology Department, National Cancer Center Hospital. “In the EPCORE NHL-3 trial, subcutaneous epcoritamab monotherapy demonstrated responses in a considerable number of patients with relapsed/refractory DLBCL, indicating that this approval is of great significance.”

The approval of EPKINLY in Japan is based on the results from two open-label, multi-center studies designed to evaluate the safety and preliminary efficacy of EPKINLY monotherapy in patients with R/R LBCL. In the phase 1/2 EPCORE NHL-1 trial, 157 patients with relapsed or refractory LBCL demonstrated an overall response rate (ORR) of 63 percent ([95 percent confidence interval (CI): 55.0-70.6]) and a complete response (CR) rate of 39 percent (data cutoff: January 31, 2022). Of 157 patients treated with EPKINLY, 130 (82.8 percent) experienced treatment related side effects. The most common side effects (>15 percent) included cytokine release syndrome (49.7 percent), injection site reactions (19.7 percent), and neutropenia (17.8 percent).

In the phase 1/2 EPCORE NHL-3 trial, 36 patients with relapsed or refractory DLBCL after two or more lines of treatment demonstrated similar results with an ORR of 56 percent ([95 percent CI: 38.1-72.1]) and a CR rate of 44 percent (data cutoff: January 31, 2022). Of 36 patients treated with EPKINLY, 36 (100 percent) experienced treatment related side effects. The most common side effects (>15 percent) included cytokine release syndrome (83.3 percent), injection site reactions (58.3 percent), neutropenia (30.6 percent), lymphopenia (19.4 percent), decreased appetite (19.4 percent), thrombocytopenia (19.4 percent), and rash (19.4 percent).

“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.”