AbbVie submits application for lymphoma therapy epcoritamab to EMA

AbbVie has announced its submission of a Marketing Authorization Application to the European Medicines Agency (EMA) for epcoritamab – an investigational subcutaneous bispecific antibody – for the treatment of adult patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy.

Co-developer Genmab has also submitted a Biologics License Application to the US Food and Drug Administration for epcoritamab for the treatment of adult patients with R/R large B-cell lymphoma (LBCL) after two or more lines of systemic therapy.

Both regulatory submissions are supported by previously announced results from the LBCL cohort of the EPCORE NHL-1 open-label, multi-centre, phase 2 trial evaluating the safety and preliminary efficacy of investigational epcoritamab in adult patients with relapsed, progressive or refractory CD20+ mature B-cell non-Hodgkin's lymphoma (NHL), including DLBCL.

In the study, treatment with epcoritamab demonstrated deep and durable responses with an overall response rate (ORR) of 63% and a complete response rate (CR) of 39% in patients who had previously received at least two prior lines of systemic anti-lymphoma therapy.

Additionally, patients naïve to treatment with chimeric antigen receptor (CAR) T-cell therapy achieved 69% ORR and 42% CR and patients previously treated with CAR T achieved a 54% ORR and 34% CR.

The safety profile of epcoritamab was manageable and consistent with previous findings, the companies reported, with the majority of treatment-emergent adverse events occurring during the first 12 weeks of treatment and being resolved.

LBCL and its major subtype, DLBCL, are fast-growing types of NHL, a cancer that develops in the lymphatic system and affects B-cell lymphocytes. DLBCL is the most common type of NHL worldwide, accounting for approximately 30% of all global NHL cases.

Epcoritamab is being co-developed by AbbVie and Genmab as part of the companies' oncology collaboration. The companies will share commercial responsibilities in the US and Japan, with AbbVie responsible for further global commercialisation.

Commenting on the applications, Mohamed Zaki, vice president and head, global oncology development, AbbVie, said: "The regulatory submissions for epcoritamab exemplify our pursuit to deliver innovative care for people living with large B-cell lymphoma and diffuse large B-cell lymphoma who have limited treatment options.

"This achievement represents an initial step in our commitment to scientific research and providing an important treatment option with the potential to become a core therapy for people living with B-cell malignancies such as LBCL and DLBCL.”