The European Commission (EC) has granted conditional marketing authorization for TEPKINLY® (epcoritamab) as a monotherapy for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy, according to AbbVie (NYSE: ABBV).
Tepkinly is the first and only subcutaneous T-cell engaging bispecific antibody approved in the European Union (EU), as well as Liechtenstein, Norway, and Iceland, for the treatment of this patient population.
Developmental timeline of Tepkinly
AbbVie and Genmab are co-developing TEPKINLY as part of their oncology collaboration. The companies will split commercial responsibilities in the United States and Japan, with AbbVie in charge of global marketing. Throughout the year, AbbVie will pursue regulatory applications for epcoritamab in overseas markets.
US APPROVAL- US approved epcoritamab under the brand name EPKINLY™ (epcoritamab-bysp) in May 2023 for the treatment of adult patients with R/R DLBCL, not otherwise specified, including DLBCL arising from indolent lymphoma, and high-grade B-cell lymphoma, after two or more lines of systemic therapy.
Basis of EU approval of Tepkinly:
The conditional* EU approval of Tepkinly is supported by the data from the pivotal EPCORETM NHL-1 Phase 1/2 open-label, multi-cohort, multi-center, single-arm trial evaluating the preliminary effectiveness and safety of TEPKINLY in patients with R/R large B-cell lymphoma (LBCL), including its subtype DLBCL.
*Medicines that fulfil an unmet medical need, where the advantage of rapid access to patients outweighs the risk of restricted data availability, and where thorough data will be provided, are awarded conditional marketing authorization.
In this trial, DLBCL patients treated with TEPKINLY (N=139) had a 62% overall response rate and a 39% complete response rate. The median response time was 15.5 months (range: 9.7 to not reached).
Tepkinly’s preliminary efficacy and safety in patients with R/R large B-cell lymphoma (LBCL), including its subtype DLBCL, was supported by data from the pivotal EPCORETM NHL-1 Phase 1/2 open-label, multi-cohort, multi-center, single-arm trial.
The trial results showed that TEPKINLY had a manageable safety profile across the LBCL patient cohort (N=167), which included DLBCL patients. Cytokine release syndrome, weariness, neutropenia, injection site reaction, musculoskeletal discomfort, stomach pain, pyrexia, nausea, and diarrhoea were the most prevalent side effects (20%).
“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,” said Roopal Thakkar, senior vice president, development and regulatory affairs, chief medical officer, AbbVie. “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. We remain committed to developing new innovative medicines that help improve the lives of people with hematological cancers.”
“Relapsed or refractory DLBCL is an aggressive cancer and patients can face a difficult and emotional treatment journey. At this point in the journey, a patient may have had multiple lines of therapy and will already have experienced relapse,” said Anna Sureda, M.D., Ph.D., head of clinical hematology department, Institut Català d’Oncologia – L’Hospitalet, Barcelona, Spain. “This European Commission approval represents an important moment for the DLBCL patient community and brings with it a potential opportunity for effective disease management for a condition with limited available treatment options.”
About the EPCORE™ NHL-1 Trial:
EPCORETM NHL-1 assessed epcoritamab as a monotherapy in patients with CD20+ R/R large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL), following two or more lines of systemic treatment. The study had two parts: dosage escalation and expansion. The total response rate defined by the Lugano criteria (2014) as assessed by an independent review committee was the primary efficacy outcome.
About Tepkinly:
Tepkinly is an experimental IgG1-bispecific antibody developed by Genmab using their patented DuoBody® technology. Genmab’s DuoBody®-CD3 technology is intended to specifically direct cytotoxic T-cells to trigger an immune response against target cell types. Tepkinly is designed to attach to CD3 on T-cells and CD20 on B-cells at the same time, inducing T-cell-mediated death of CD20+ cells.4 CD20 is a clinically recognised therapeutic target in numerous B-cell malignancies, including DLBCL, follicular lymphoma, mantle cell lymphoma, and chronic lymphocytic leukaemia.
