Abbvie (ABBV.US) has received EU approval for another potential blockbuster dual-target antibody therapy.
August 20, 2023, AbbVie (ABBV.US) and Genmab (GMAB.US) jointly announced that the European Commission (EC) has approved the expanded indication of Tepkinly (ecoritamab) for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) who have received two or more lines of systemic therapy. According to the press release, Tepkinly is the first subcutaneous injection T cell engaging bispecific antibody approved in the EU for the treatment of R/R FL and R/R diffuse large B cell lymphoma (DLBCL). It is worth mentioning that this innovative therapy was also evaluated by industry media as one of the top 10 potential blockbuster therapies in 2023.
It was reported that this approval was mainly based on the results of the EPCORE NHL-1/2 trial, which assessed the efficacy and safety of Tepkinly in 127 patients with R/R FL. The analysis showed that the overall response rate (ORR) was 83%, with a complete response rate (CR) of 63%. In addition, the median duration of response (DoR) was 21.4 months at a median follow-up of 16.2 months. These results were recently published in the Lancet Haematology.
Tepkinly is a subcutaneous agent based on Genmab's proprietary DuoBody technology, which builds an IgG1 subtype bispecific antibody. Genmab's DuoBody-CD3 technology aims to selectively direct cytotoxic T cells to target cell types through an immune response. It simultaneously binds CD3 on T cells and CD20 on B cells and induces T cell-mediated CD20-positive cell killing. It was first approved by the US FDA (brand name Epkinly) in May last year for the treatment of R/R DLBCL.