TEPKINLY® (epcoritamab) Gains Approval from the European Commission
Company Announcement
TEPKINLY has become the first and only subcutaneous bispecific antibody approved as a standalone treatment in the European Union for both relapsed or refractory (R/R) follicular lymphoma (FL) and R/R diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy.
COPENHAGEN, Denmark; August 2024 – Genmab A/S (Nasdaq: GMAB) has announced that the European Commission (EC) has granted conditional marketing authorization for TEPKINLY (epcoritamab) as a monotherapy for adult patients suffering from relapsed or refractory (R/R) follicular lymphoma (FL) following two or more lines of systemic therapy. This makes TEPKINLY the first and only subcutaneous T-cell engaging bispecific antibody approved for this patient group in the European Union, the European Economic Area (EEA) countries, and Northern Ireland.
“Treating follicular lymphoma can be quite challenging, and today’s approval of TEPKINLY represents a significant milestone for patients in the European Union who are in need of more treatment options,” stated Jan van de Winkel, Ph.D., President and Chief Executive Officer of Genmab. “Together with our partner AbbVie, we are dedicated to further developing epcoritamab as a potential core therapy for various B-cell malignancies.”
What is Follicular Lymphoma?
Follicular lymphoma (FL) is a slow-growing type of non-Hodgkin lymphoma (NHL) that originates from B-cell lymphocytes. It accounts for 20-30% of all NHL cases and represents 10-20% of all lymphomas in Western countries. Typically considered incurable, there is currently no standard treatment available for patients with third-line or later FL. Those who achieve remission often experience relapse, complicating their management.
Insights from Clinical Trials
The conditional approval of TEPKINLY is based on findings from the Phase 1/2 EPCORE NHL-1 clinical trial, which assessed the efficacy of TEPKINLY as a monotherapy in patients with R/R FL following systemic therapy. Among the trial participants, a considerable number were refractory to anti-CD20 monoclonal antibody therapy and an alkylating agent. The trial reported an overall response rate (ORR) of 83% and a complete response (CR) rate of 63%. The median duration of response was recorded at 21.4 months during a median follow-up of 16.2 months.
Evaluating Safety and Effectiveness
Results from the trial indicated that 40% of patients in the optimization cohort experienced Grade 1 cytokine release syndrome (CRS), while 9% experienced Grade 2, with no cases of Grade 3 or higher CRS reported. The safety profile revealed that the most common adverse reactions (occurring in 20% or more of patients) included CRS, injection site reactions, fatigue, and viral infections.
“The European Commission's approval of epcoritamab is an encouraging development for the lymphoma community,” remarked Kate Rogers, CEO of the Follicular Lymphoma Foundation. “Given the challenges of treating relapsed or refractory follicular lymphoma, it is essential for patients and healthcare providers to have additional treatment options available.”
Overview of the EPCORE NHL-1 Trial
The EPCORE NHL-1 trial was designed in three phases: dose escalation, expansion, and optimization. Its primary endpoint was the overall response rate (ORR), while secondary endpoints focused on the duration of complete response, progression-free survival, and time to response. The results support further investigation across different patient cohorts.
About Epcoritamab
Epcoritamab is administered subcutaneously and is a bispecific antibody developed using Genmab's DuoBody technology. This innovative antibody targets both CD3 on T cells and CD20 on B cells, triggering selective immune responses against CD20+ cells. Epcoritamab is marketed under the brand names EPKINLY in the U.S. and Japan, and TEPKINLY in the EU. It is developed collaboratively by Genmab and AbbVie, with both companies actively seeking additional regulatory approvals worldwide.
Future Research and Directions
Genmab and AbbVie are committed to exploring the potential of epcoritamab as both a standalone treatment and in combination therapies for a range of hematologic conditions. This includes multiple Phase 3 trials aimed at establishing the efficacy of epcoritamab in various treatment scenarios for lymphoma patients.
About Genmab
Founded in 1999, Genmab is an international biotechnology company based in Copenhagen, Denmark. Its mission is to improve patients' lives through innovative antibody therapeutics. With a diverse portfolio that includes bispecific T-cell engagers and immune checkpoint modulators, Genmab strives to revolutionize cancer treatment on a global scale.
Contact:
Marisol Peron, Senior Vice President, Global Communications & Corporate Affairs
T: +1 609 524 0065; E: mmp@genmab.com
Andrew Carlsen, Vice President, Head of Investor Relations
T: +45 3377 9558; E: acn@genmab.com
Frequently Asked Questions
1. What is TEPKINLY used for?
TEPKINLY is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma and diffuse large B-cell lymphoma after they have undergone two or more lines of systemic therapy.
2. Who developed TEPKINLY?
TEPKINLY (epcoritamab) was developed by Genmab A/S in partnership with AbbVie.
3. Why is the EC approval for TEPKINLY significant?
The EC approval of TEPKINLY represents a major advancement in treatment options for patients facing difficult-to-treat forms of lymphoma, especially after multiple lines of therapy.
4. How does TEPKINLY function?
TEPKINLY is a bispecific antibody that directs immune responses against CD20+ B cells by engaging T cells, thereby enhancing their proliferation and cytotoxicity against the target cells.
5. What side effects are commonly associated with TEPKINLY?
Common side effects include cytokine release syndrome, injection site reactions, fatigue, neutropenia, and viral infections. It is important to monitor patients during treatment for any severe reactions.
