The conditional approval is based on the results from the EPCORE NHL-1 Phase 1/2 trial in which the DLBCL patients treated with Tepkinly achieved an overall response rate of 62% and a complete response rate of 39%
EC clears AbbVie’s Tepkinly. (Credit: AbbVie Inc.)
AbbVie has received conditional marketing authorisation from the European Commission (EC) for Tepkinly (epcoritamab) for adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL).
Co-developed by AbbVie and Denmark-based Genmab, Tepkinly is an investigational IgG1-bispecific antibody. It was created using Genmab’s proprietary DuoBody technology.
EC has approved the antibody-drug as monotherapy after two or more lines of systemic therapy.
AbbVie chief medical officer and development and regulatory affairs SVP Roopal Thakkar said: “The European Commission approval of epcoritamab represents a significant milestone in our aspiration with Genmab to develop a potential core therapy for patients with B-cell malignancies, like DLBCL.
“With this milestone achievement, Tepkinly is now the second approved cancer treatment in the EU from our oncology portfolio, and AbbVie’s third blood cancer medicine across the world.”
The conditional approval is based on the results from the EPCORE NHL-1 Phase 1/2 trial in which the primary efficacy endpoint was the overall response rate (ORR) determined by Lugano criteria as assessed by an independent review committee.
As per the findings, DLBCL patients treated with Tepkinly achieved an overall response rate of 62% and a complete response rate of 39%.
The median duration of response was observed at 15.5 months with the antibody drug showing a manageable safety profile across the LBCL patient cohort, which included the DLBCL patient population.
Genmab CEO Jan van de Winkel said: “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.
“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.”
In a separate development, the American pharmaceutical company ceased its 2020 deal with China-based biotech company I-Mab to co-develop and market the latter’s lead cancer drug candidate lemzoparlimab.
AbbVie’s decision to terminate the agreement follows the dissolution of an early-stage study in August 2022 that tested lemzoparlimab in combination with two additional drugs to treat two forms of blood malignancies.