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 analyse the safety and preliminary efficacy of the antibody with a Phase I dose-escalation part, a Phase II expansion part and an optimisation part.
It is analysing 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.
In the trial, epcoritamab’s safety profile was in line with prior data.
AbbVie global oncology development vice-president and head Mohamed Zaki said: “The epcoritamab data suggests a potentially compelling clinical profile for patients with relapsed/refractory LBCL, which currently have limited treatment options.
“Our partnership with Genmab allows us to continue exploring new standards of care for patients with blood cancer.”
In April this year, the company reported positive data from the Phase II REFINE trial of navitoclax with ruxolitinib for treating myelofibrosis.
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