Genmab’s Epcoritamab Evaluated in Phase 3 Clinical Trial Targeting Relapsed Refractory Diffuse Large B-Cell Lymphoma

Genmab’s Epcoritamab Evaluated in Phase 3 Clinical Trial Targeting Relapsed Refractory Diffuse Large B-Cell Lymphoma TrialsiteN

Danish biotech venture Genmab in partnership with American multinational pharmaceutical company AbbVie recently launched a Phase 3 clinical trial to investigate the efficacy of epcoritamab (GEN3013 DuoBody®–CD3xCD20) compared to the investigator’s choice of chemotherapy in patients with relapsed refractory diffuse large B-cell Lymphoma who have failed or are ineligible for HDT-ASCT.  Conducted in at least 5 European countries at major academic medical centers and tertiary hospitals, eligible patients are randomized 1:1 to either the study drug or the investigator’s choice of chemotherapy including R-GemOx (rituximab, gemcitabine and oxaliplatin) or BR (bendamustine and rituximab). With a primary endpoint targeting overall survival, secondary endpoints include progression-free survival, overall response rate, complete response and more. Targeting 483 participants, the study runs through this year all the way to spring of 2024. The dosage of the first patient in January triggered a $40 million milestone payment from AbbVie to Genmab.

What is Epcoritamab?

Generally a class of biologic drug known as CD20-specific monoclonal antibodies (mAbs) have evidenced promise in the treatment of B-cell non-Hodgkin lymphomas (B-NHL), but problematically a sizeable proportion of patients present with refractory disease or relapse. This particular therapy, GEN3013 (DuoBody®-CD3xCD20) is the first subcutaneously administered IgG1 bispecific antibody (bsAb) targeting T-cell surface antigen CD3 and the B-cell surface antigen CD20, instigating T-cell mediated termination of B cells. While in lab environments (In vitro), GEN3013 “efficiency activates and induces cytotoxic activity of CD4+ and CD8+ T cells in the presence of B cells according to a study by Hiemstra et al. Blood 2018) as well as long lasting results B cells in cynomolgus monkeys in preclinical research.

GEN3013 exhibits more potency in vitro than a majority of CD3xCD20 bsAbs in clinical development reports, Hiemstra et. al. in HemaSphere 2019

As identified in the Genmab pipeline, this investigational drug, evaluated ongoing in a Phase 1/2 clinical trial (NCT03625037), now is active in a Phase 3 clinical trial.

With the first patient in the Phase 3 European study dosed in January, the Danish biotech announced the trigger of the first $40 million milestone payment associated with the co-development of epcoritamab. 

The Genmab and AbbVie partnership

The two companies announced and broadening and deepening of collaborative co-development in June 2020 to jointly develop and commercialize three of Genmab’s early-stage investigational bispecific antibody product candidates while also teaming on a discovery research collaboration for future differentiated antibody therapeutics for cancer.

The company partnered to develop the following Genmab next-generation bispecific antibody programs: epcoritamab, DuoHexaBody®-CD37 and DuoBody-CD3x5T4.

The two joined forces to combine the world-class discovery and development engine and next-generation bispecific antibody therapeutic candidates built by Genmab with AbbVie’s deep clinical expertise, innovative antibody-drug conjugate (ADC) platform and global commercial leadership in hematological cancers.