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)

Genmab A/S (Nasdaq: GMAB) announced today that the Japan Ministry of Health, Labour and Welfare has approved EPKINLY (epcoritamab) as the first and only T-cell engaging bispecific antibody treatment in Japan of adult patients with certain types of relapsed or refractory large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL), high-grade B-cell lymphoma (HGBCL), primary mediastinal large B-cell lymphoma (PMBCL) and follicular lymphoma grade 3B (FL3B), after two or more lines of systemic therapy. Epcoritamab is being co-developed by Genmab and AbbVie as part of the companies' oncology collaboration.

“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).