Tepkinly是一种皮下给药，基于Genmab公司专有的DuoBody技术构建的IgG1亚型双特异性抗体。Genmab的DuoBody-CD3技术旨在选择性地引导细胞毒性T细胞向靶细胞类型产生免疫反应。它同时结合T细胞上的CD3和B细胞上的CD20，并诱导T细胞介导的CD20阳性细胞的杀伤。它在去年5月首次获得美国FDA的批准(商品名Epkinly)，治疗R/R DLBCL。On August 20th, Abbvie (ABBV.US) and genmab (GMAB.US) jointly announced that the European Commission has approved Tepkinly (Epcoritamab) for expanded indications, for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL).
According to the Finance and Economics APP, on August 20th, Abbvie (ABBV.US) and genmab (GMAB.US) jointly announced that the European Commission has approved the expansion of indications for Tepkinly (Epcoritamab) for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL), who had previously received second-line or later systemic therapy. The press release states that Tepkinly is the first subcutaneous injection T-cell bispecific antibody approved by the EU for the treatment of R/R FL and R/R diffuse large B-cell lymphoma (DLBCL). It is worth noting that this innovative therapy was also listed as one of the top ten potential blockbuster therapies in 2023 by industry media Evaluate.
It is reported that this approval is mainly based on the results of the EPCORE NHL-1 clinical phase 1/2 trial, which evaluated the efficacy and safety of Tepkinly in 127 R/R FL patients. The analysis showed that the overall response rate (ORR) of patients reached 83%, and the complete response rate (CR) was 63%. In addition, at a median follow-up time of 16.2 months, the median duration of response (DoR) was 21.4 months. These results were recently published in the Lancet Haematology, a sub-journal of the Lancet.
Tepkinly is a subcutaneously administered IgG1 subtype bispecific antibody based on genmab's proprietary Duobody technology. Genmab's Duobody-CD3 technology aims to selectively guide cytotoxic T cells to produce an immune response to target cell types. It simultaneously binds to CD3 on T cells and CD20 on B cells, inducing T cell-mediated killing of CD20-positive cells. It was first approved by the US FDA in May of last year (under the trade name Epkinly) for the treatment of R/R DLBCL.