The companies will plan the next steps in development following a discussion with regulatory authorities around the globe.
Epkinly is an IgG1 bispecific antibody that initiates a targeted T-cell mediated immune response by binding to CD20 and CD-3 receptors on the T-cell and B-cells, respectively.
Epkinly received accelerated approval from the US Food and Drug Administration (FDA) in May 2023, and an orphan medicine designation from the European Medicines Agency (EMA) for relapsed or refractory diffuse large B-cell lymphoma (DLBCL).
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Phase I/II data
The open-label, multicentre EPCORE NHL-1 trial (NCT03625037) evaluated the safety and efficacy of Epkinly in 128 adult patients with relapsed/refractory FL.
The data was first presented in the first week of June 2023 at the American Society of Clinical Oncology (ASCO) and the European Haematology Association (EHA). The data has now been confirmed by an independent review committee (IRC).
The overall response rate (ORR) was 82%; however, the median duration of response was not reached.
The most common adverse event, cytokine release syndrome (CRS), was observed in 66.4% of the study population.
The results from the dose-optimisation portion of the trial are currently under evaluation, with their presentation expected at an upcoming medical congress.
The updated data from the large B-cell lymphoma (LBCL) expansion cohort from the EPCORE NHL-1 was reported on 6 June 2023.
Epkinly is being co-developed as part of an oncology collaboration deal between AbbVie and Genmab signed in June 2020. AbbVie and Genmab would split commercial responsibilities into the US and Japan while AbbVie will oversee the global commercialisation.