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Epcoritamab

Epcoritamab is an investigational bispecific antibody being studied in clinical trials for the treatment of various B-cell lymphomas, including diffuse large B-cell lymphoma (DLBCL), follicular lymphoma, and other aggressive mature B-cell neoplasms. This article summarizes key information from ongoing clinical trials evaluating the safety and efficacy of epcoritamab in patients with relapsed or refractory disease.

Table of Contents

What is Epcoritamab?

Epcoritamab is an investigational drug being developed to treat various types of B-cell lymphomas, which are cancers that affect a type of white blood cell called B-cells[1]. It is a new type of treatment known as a bispecific antibody, which is a synthetic protein designed to activate the immune system to target cancer cells[2].

Epcoritamab is also known by other names, including:

  • GEN3013
  • ABBV-GMAB-3013
  • DuoBody-CD3xCD20[1][2]

How Does Epcoritamab Work?

Epcoritamab works in a unique way by connecting two important parts of the immune system:

  1. It binds to a protein called CD20, which is found on B-cells (including cancerous B-cells).
  2. It also binds to CD3, a protein found on T-cells, which are another type of immune cell that helps fight cancer.

By connecting these two cell types, epcoritamab helps activate T-cells to recognize and destroy cancerous B-cells[3]. This targeted approach aims to be more effective and potentially have fewer side effects than traditional chemotherapy.

What Conditions Does Epcoritamab Treat?

Epcoritamab is being studied to treat several types of B-cell lymphomas, including:

  • Diffuse Large B-Cell Lymphoma (DLBCL): An aggressive type of non-Hodgkin lymphoma[1]
  • Follicular Lymphoma (FL): A slow-growing type of non-Hodgkin lymphoma[1]
  • Waldenstrom Macroglobulinemia (WM): A rare type of slow-growing non-Hodgkin lymphoma[4]
  • Chronic Lymphocytic Leukemia (CLL) and Richter Syndrome: Types of blood and bone marrow cancers[5]

These conditions are typically treated when they have relapsed (come back after treatment) or become refractory (stopped responding to previous treatments).

How is Epcoritamab Administered?

Epcoritamab is given as a subcutaneous injection, which means it is injected under the skin[1]. The treatment is usually given in cycles, with each cycle lasting 28 days. The dosing schedule may vary depending on the specific condition being treated and the stage of treatment[3].

Typically, patients start with lower doses that gradually increase to the full dose over the first few weeks of treatment. This approach, known as “step-up dosing,” is used to help reduce the risk of side effects[6].

Current Clinical Trials

Epcoritamab is currently being studied in several clinical trials for different conditions and treatment approaches. Some notable trials include:

  • A study combining epcoritamab with other treatments before and after stem cell transplantation for large B-cell lymphomas[7]
  • A trial investigating epcoritamab in pediatric patients with relapsed or refractory B-cell lymphomas[8]
  • A study looking at epcoritamab treatment for patients with follicular lymphoma who didn’t achieve a complete response with initial therapy[2]

Potential Side Effects

As with any cancer treatment, epcoritamab can cause side effects. Some of the most important side effects to be aware of include:

  • Cytokine Release Syndrome (CRS): This is an inflammatory response that can cause fever, chills, and other flu-like symptoms. It’s usually mild but can sometimes be severe[1].
  • Neurological effects: Some patients may experience confusion, difficulty speaking, or other neurological symptoms[1].
  • Infections: Because epcoritamab affects the immune system, it may increase the risk of infections[6].

Doctors closely monitor patients for these and other side effects during treatment. Some trials are even exploring ways to prevent or reduce these side effects, such as using other medications before epcoritamab treatment[3].

Future Prospects

While epcoritamab is still an investigational drug, early results from clinical trials have been promising. Researchers are exploring its use in various types of lymphomas and at different stages of treatment. If successful, epcoritamab could provide a new option for patients who have not responded well to other treatments[6][2].

As research continues, we may learn more about how effective epcoritamab is, which patients benefit most from it, and how to best manage any side effects. Patients interested in epcoritamab should discuss with their doctors whether participating in a clinical trial might be appropriate for their situation.

Aspect Details
Drug Name Epcoritamab (also known as ABBV-GMAB-3013, GEN3013, DuoBody-CD3xCD20)
Drug Type Bispecific antibody targeting CD3 and CD20
Administration Subcutaneous injection
Conditions Studied Diffuse Large B-Cell Lymphoma (DLBCL), Follicular Lymphoma, Burkitt Lymphoma, Waldenström Macroglobulinemia, other aggressive B-cell neoplasms
Trial Phases Phase 1b, Phase 2
Key Outcomes Measured Safety, tolerability, overall response rate, complete response rate, progression-free survival, overall survival
Common Side Effects Monitored Cytokine Release Syndrome (CRS), Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS), other neurological toxicities
Treatment Schedule Typically 28-day cycles, with varying dosing schedules depending on the trial

FAQ

  • What is epcoritamab? Epcoritamab is a bispecific antibody that targets both CD3 on T-cells and CD20 on B-cells. It is designed to activate the immune system to attack cancer cells in B-cell lymphomas.
  • What types of lymphoma is epcoritamab being studied for? Epcoritamab is being evaluated in clinical trials for several B-cell lymphomas, including diffuse large B-cell lymphoma (DLBCL), follicular lymphoma, Burkitt lymphoma, and Waldenström macroglobulinemia.
  • How is epcoritamab administered? Epcoritamab is given as a subcutaneous (under the skin) injection, typically in 28-day cycles. The dosing schedule may vary depending on the specific trial.
  • What are some potential side effects of epcoritamab? Common side effects being monitored include cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), and other neurological toxicities. The severity and frequency of these effects are being closely studied.
  • Is epcoritamab approved for use outside of clinical trials? As of now, epcoritamab is still an investigational drug. It has been approved by the FDA for certain uses, but is still being studied in clinical trials for various lymphoma types and treatment settings.

Ongoing Clinical Trials on Epcoritamab

  • Study of Epcoritamab for Patients with Relapsed, Progressive, or Refractory B-Cell Lymphoma

    Not recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    Denmark Finland France Germany Italy The Netherlands +3

  • Study Comparing Epcoritamab with Chemotherapy for Patients with Relapsed or Refractory B-cell Lymphoma

    Not recruiting

    3 1 1 1
    Investigated drugs:
    Austria Belgium Denmark Finland France Germany +7

  • Study on the Safety and Effectiveness of Epcoritamab with Rituximab and Lenalidomide for Patients with Relapsed or Refractory Follicular Lymphoma

    Not recruiting

    3 1 1 1
    Investigated drugs:
    Austria Belgium Czechia Denmark France Germany +8

  • Study on the Safety and Effectiveness of Epcoritamab with R-CHOP for Patients with Newly Diagnosed Diffuse Large B-Cell Lymphoma (DLBCL)

    Not recruiting

    3 1 1 1
    Investigated drugs:
    Austria Belgium Bulgaria Croatia Czechia Denmark +10

  • Study on Epcoritamab, Rituximab, and Lenalidomide for Adults with Untreated Follicular Lymphoma

    Not recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium Bulgaria Croatia Czechia Denmark France +11

  • Study on the Safety and Effectiveness of Epcoritamab, Venetoclax, and Lenalidomide for Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia and Richter’s Syndrome

    Not recruiting

    1 1 1 1
    Investigated drugs:
    Belgium Czechia Denmark France Germany Italy +3

  • Study on the Safety of Epcoritamab for Children and Young Adults with Relapsed or Refractory Aggressive B-cell Lymphomas

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium Czechia France Germany Italy Spain

  • Study on the Effectiveness and Safety of Epcoritamab Alone or with Lenalidomide for Patients with Diffuse Large B-Cell Lymphoma Who Cannot Use Anthracyclines

    Not recruiting

    2 1 1 1
    Investigated drugs:
    Austria Belgium Czechia France Germany Italy +2

  • Study on the Safety and Effectiveness of Epcoritamab with a Drug Combination for Patients with B-cell Non-Hodgkin Lymphoma

    Not recruiting

    1 1 1 1
    Investigated drugs:
    Belgium Czechia Denmark Finland France Italy +4

Glossary

  • Bispecific antibody: A type of engineered antibody that can bind to two different targets simultaneously. In the case of epcoritamab, it binds to CD3 on T-cells and CD20 on B-cells.
  • Cytokine Release Syndrome (CRS): A condition that can occur as a side effect of certain immunotherapies, characterized by fever, low blood pressure, and difficulty breathing.
  • Diffuse Large B-Cell Lymphoma (DLBCL): An aggressive type of non-Hodgkin lymphoma that affects B-cells.
  • Follicular Lymphoma: A slow-growing type of non-Hodgkin lymphoma that affects B-cells.
  • Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS): A neurological side effect that can occur with certain immunotherapies, potentially causing confusion, difficulty speaking, or seizures.
  • Relapsed/Refractory (R/R): Refers to cancer that has returned after treatment (relapsed) or has not responded to initial treatment (refractory).
  • Subcutaneous injection: A method of administering medication by injecting it under the skin.
  • Waldenström Macroglobulinemia: A rare type of slow-growing non-Hodgkin lymphoma that affects B-cells.

References

  1. https://clinicaltrials.gov/study/NCT05451810
  2. https://clinicaltrials.gov/study/NCT06510361
  3. https://clinicaltrials.gov/study/NCT06447376
  4. https://clinicaltrials.gov/study/NCT06510491
  5. https://clinicaltrials.gov/study/NCT06676033
  6. https://clinicaltrials.gov/study/NCT06414148
  7. https://clinicaltrials.gov/study/NCT06287398
  8. https://clinicaltrials.eu/trial/study-on-the-safety-of-epcoritamab-for-children-and-young-adults-with-relapsed-or-refractory-aggressive-b-cell-lymphomas/