AbbVie and Genmab announced that their cancer treatment Tepkinly (epcoritamab) has received a second conditional marketing authorisation from the European Commission (EC).
Tepkinly is a T-cell engaging IgG1-bispecific antibody treatment jointly developed under an oncology collaboration between Genmab and AbbVie.
Created using Genmab’s unique DuoBody technology, the drug was initially approved to treat adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after systemic therapy.
The second EC approval expands Tepkinly’s indication to include the treatment of adults with relapsed or refractory (R/R) follicular lymphoma (FL) after two or more lines of prior therapy.
Tepkinly was already approved in the US and Japan, under the brand name Epkinly, and has received regulatory approval in certain lymphoma indications in several territories.
AbbVie vice president and haematology therapeutic area head Mariana Cota Stirner said: “The European approval of Tepkinly for the treatment of follicular lymphoma after two or more prior treatments is yet another step forward in our aspiration to develop Tepkinly as a potential core therapy across multiple B-cell malignancies.
“First approved for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma, its expansion into follicular lymphoma underscores its utility as a haematological cancer treatment.
“Together with our partner, Genmab, we are thrilled with today’s approval which advances our commitment to elevating care for people living with cancer.”
The EC conditional marketing authorisation is supported by data from EPCORE NHL-1, an open-label, multi-cohort, multicentre, single-arm, Phase 1/2 clinical trial.
The Phase 1/2 EPCORE NHL-1 study evaluated Tepkinly as monotherapy in adult patients with R/R FL after two or more lines of prior systemic therapy.
In the study, patients treated with Tepkinly resulted in an overall response rate (ORR) of 83% and a complete response (CR) rate of 63%.
The Phase 1/2 trial also included a separate optimisation cohort, comprising 86 patients with the recommended three-step-up doses for cytokine release syndrome (CRS) mitigation.
Genmab president and CEO Jan van de Winkel said: “Follicular lymphoma can be challenging to treat and today’s approval of Tepkinly for the treatment of R/R FL after two or more lines of systemic therapy marks an important milestone for patients in the European Union.
“Alongside our partner AbbVie, we are committed to exploring the continued development of epcoritamab as a potential core therapy across B-cell malignancies.”
Genmab and AbbVie are planning to further evaluate Tepkinly as a monotherapy and in combination, in four ongoing Phase 3 clinical trials, across different hematologic malignancies.
