TEPKINLY Secures European Approval for Follicular Lymphoma Treatment
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TEPKINLY® (epcoritamab) Receives European Commission Approval
Company Announcement
TEPKINLY is the first and only subcutaneous bispecific antibody approved as a monotherapy in the European Union to treat 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) today announced that 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) follicular lymphoma (FL) after two or more lines of systemic therapy. TEPKINLY is the first and only subcutaneous T-cell engaging bispecific antibody approved for this patient population in the European Union, European Economic Area (EEA) countries, and Northern Ireland.
“Follicular lymphoma can be challenging to treat and today’s approval of TEPKINLY marks an important milestone for patients in the European Union who are in need of more options,” said Jan van de Winkel, Ph.D., President and Chief Executive Officer of Genmab. “Alongside our partner AbbVie, we are committed to exploring the continued development of epcoritamab as a potential core therapy across B-cell malignancies.”
Understanding Follicular Lymphoma
FL is a slow-growing form of Hodgkin’s lymphoma (NHL) originating from B-cell lymphocytes. It accounts for 20-30 percent of all NHL cases, representing 10-20 percent of all lymphomas in Western countries. Typically classified as incurable, there is currently no standard treatment for third-line or later FL. Patients achieving remission often face relapse, complicating management.
Clinical Trial Insights
The conditional approval is based on data from the Phase 1/2 EPCORE NHL-1 clinical trial, which evaluated TEPKINLY as monotherapy in patients with R/R FL post systemic therapy. Among the participants, a significant portion was refractory to anti-CD20 monoclonal antibody therapy and an alkylating agent, with a reported 83% overall response rate (ORR) and a 63% complete response (CR) rate. The median duration of response was noted at 21.4 months during a median follow-up of 16.2 months.
Safety and Effectiveness Analysis
The trial’s results indicated that 40% of patients in the optimization cohort experienced Grade 1 cytokine release syndrome (CRS) and 9% experienced Grade 2, with no reports of Grade 3 or higher CRS. Safety profiles showed that the most common adverse reactions (? 20%) included CRS, injection site reactions, fatigue, and viral infections.
“The approval of epcoritamab by the European Commission is a promising update for the lymphoma community,” stated Kate Rogers, CEO of the Follicular Lymphoma Foundation. “Given that relapsed or refractory follicular lymphoma can be very challenging to treat, it is critical that patients and physicians have additional options.”
About the EPCORE NHL-1 Trial
The EPCORE NHL-1 trial was structured in three parts: dose escalation, expansion, and optimization. Its primary endpoint was overall response rate (ORR), while secondary endpoints evaluated the duration of complete response, progression-free survival, and time to response, with results supporting further evaluation across different patient cohorts.
About Epcoritamab
Epcoritamab, administered subcutaneously, is a bispecific antibody developed using Genmab's DuoBody technology. This antibody targets both CD3 on T cells and CD20 on B cells, inducing selective immune responses against CD20+ cells. Epcoritamab is recognized under the brand names EPKINLY in the U.S. and Japan, and TEPKINLY in the EU. It is collaboratively developed by Genmab and AbbVie, with both companies actively pursuing additional regulatory approvals worldwide.
Ongoing Research and Future Directions
Genmab and AbbVie are dedicated to evaluating the potential of epcoritamab as both a monotherapy and in combination therapies across a variety of hematologic conditions. This includes multiple Phase 3 trials aiming to establish the efficacy of epcoritamab in various treatment scenarios for lymphoma patients.
Genmab Overview
Genmab, founded in 1999, is an international biotechnology company headquartered in Copenhagen, Denmark. Its mission revolves around enhancing patients' lives through innovative antibody therapeutics. With a portfolio that includes bispecific T-cell engagers and immune checkpoint modulators, Genmab aims to transform cancer treatments globally.
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 treatment in adult patients with relapsed or refractory follicular lymphoma and diffuse large B-cell lymphoma after two or more lines of systemic therapy.
2. Who developed TEPKINLY?
TEPKINLY (epcoritamab) was developed by Genmab A/S in collaboration with AbbVie.
3. What is the significance of the EC approval for TEPKINLY?
The EC approval of TEPKINLY marks a significant advancement in treatment options for patients suffering from difficult-to-treat forms of lymphoma, particularly after multiple lines of therapy.
4. How does TEPKINLY work?
TEPKINLY is a bispecific antibody designed to direct immune responses against CD20+ B cells by engaging T cells, thereby promoting their proliferation and cytotoxicity against the target cells.
5. What are the common side effects of TEPKINLY?
Common side effects include cytokine release syndrome, injection site reactions, fatigue, neutropenia, and viral infections. Monitoring during treatment for any severe reactions is advised.
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