B-cell lymphoma new therapy trial.
AbbVie has reported initial data from the large B-cell lymphoma (LBCL) expansion cohort in the EPCORE NHL-1 Phase II clinical trial of epcoritamab (DuoBody-CD3xCD20).
Being developed jointly by AbbVie and Genmab under an oncology partnership, epcoritamab is an investigational subcutaneous IgG1-bispecific antibody.
The multicentre, open-label EPCORE NHL-1 trial is designed to analyze the safety and preliminary efficacy of the antibody with a Phase I dose-escalation part, a Phase II expansion part and an optimization part.
It is analyzing subcutaneous dose of epcoritamab in subjects with relapsed, progressive or refractory CD20+ mature B-non-Hodgkin’s lymphoma (B-NHL), including LBCL and diffuse large B-cell lymphoma (DLBCL), an LBCL subtype.
The study arm had 157 subjects with relapsed/refractory LBCL, who received a median of three lines of therapy earlier.
According to the findings, epcoritamab showed lasting responses in subjects who have priorly received a minimum of two lines of anti-lymphoma therapy, including chimeric antigen receptor (CAR) T-cell therapy.
Furthermore, the patients had an overall response rate (ORR) and complete response (CR) rate of 63% and 39%, respectively.
The trial subjects who were CAR T-cell therapy- naïve had an ORR and CR of 69% and 42%, respectively, and subjects who were previously treated with CAR T-cell therapy had a 54% ORR and a 34% CR.
The median duration of response (mDOR) was reported to be 12 months following up to 10.7 months of median follow up, but the mDOR in subjects who achieved a CR was not reached, with 89% remaining in CR at nine months.
AbbVie global oncology development vice-president and head Mohamed Zaki said: “The epcoritamab data suggest a potentially compelling clinical profile for patients with relapsed/refractory LBCL, which currently have limited treatment options.