European Commission Approves Genmab’s Subcutaneous Bispecific Antibody Tepkinly
Genmab has announced that they have been given conditional approval by the European Commission to market their bispecific antibody Tepkinly (epcoritamab). The approval allows the drug to be marketed as a monotherapy for adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL).
“Relapsed or refractory DLBCL is an aggressive cancer and patients can face a difficult and emotional treatment journey. said Anna Sureda, head of the clinical haematology department at Institut Català d’Oncologia – L’Hospitalet, in Barcelona, Spain.”
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Tepkinly has been approved for DCBL patients that have already had two or more lines of systemic therapy. Sureda continued: “At this point in the journey, a patient may have had multiple lines of therapy and will already have experienced relapse.”
What makes Tepkinly unique is its position as the first and only subcutaneous T-cell engaging bispecific approved for use in Europe. Genmab’s CEO, Jan van de Winkel commented: “With Tepkinly, people in Europe living with relapsed or refractory diffuse large B-cell lymphoma who are in need of additional treatment options now have a readily available, innovative therapeutic option for this aggressive cancer.”
The approval comes after the release of data from Genmab’s ‘Epcore’ phase I/II clinical trial. The open-label, multi-cohort, multi-centre, single-arm trial evaluated the preliminary efficacy and safety of Tepkinly in patients with R/R large B-cell lymphoma, of which DLBCL is a subtype.
Results from the study which tested 139 DLBCL patients showed an overall response rate of 62% (amounting to 86 patients) and a complete response rate of 39% (54 patients).
The safety profile for the drug was reported as being ‘manageable’, with the most common adverse reactions being cytokine release syndrome, fatigue, neutropenia, injection site reaction, musculoskeletal pain, abdominal pain, pyrexia, nausea, and diarrhoea. Each of these reactions were seen in 20% or greater of patients.
DLBCL is the most common form of B-cell non-Hodgkin’s lymphoma, despite this, Genmab reported that off-the-shelf treatment options are limited for patients with the disease.
Epcoritamab is a collaborative effort between AbbVie and Genmab within their oncology partnership. They will jointly manage commercial activities in the U.S. and Japan, while AbbVie will take the lead in expanding its global presence. AbbVie intends to pursue regulatory approvals for epcoritamab in various international markets throughout the year.
“Today’s approval underscores our commitment to bringing our bispecific antibody to more patients worldwide. We’re excited to continue working with our partner AbbVie to further explore epcoritamab as potential core therapy across B-cell malignancies,” said van de Winkel.
The conditional authorisation of Tepkinly means that it is authorised for use in patients where there is an unmet need – and the benefit to this patient population outweighs the limited data available in early stages of testing.
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