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Odronextamab

Odronextamab is an experimental drug being studied in clinical trials for various types of B-cell lymphomas, including follicular lymphoma, diffuse large B-cell lymphoma, and other non-Hodgkin lymphomas. These trials aim to assess the safety, tolerability, and effectiveness of odronextamab alone or in combination with other treatments compared to standard therapies. The research focuses on patients with both newly diagnosed and relapsed/refractory disease.

Table of Contents

What is Odronextamab?

Odronextamab, also known as REGN1979, is an experimental drug being studied for the treatment of various types of B-cell lymphomas. B-cell lymphomas are cancers that affect a type of white blood cell called B-cells, which are an important part of the immune system. Odronextamab is classified as a bispecific antibody, which means it’s designed to target two different proteins at the same time[1].

How Does Odronextamab Work?

Odronextamab works by targeting two specific proteins:

  1. CD20: This protein is found on the surface of B-cells, including cancerous B-cells.
  2. CD3: This protein is found on T-cells, another type of immune cell.

By binding to both CD20 and CD3, odronextamab acts like a bridge, bringing T-cells (the body’s natural cancer fighters) close to the cancerous B-cells. This proximity allows the T-cells to recognize and attack the cancer cells more effectively[2].

What Conditions Does Odronextamab Treat?

Odronextamab is being studied for several types of B-cell lymphomas, including:

  • Follicular Lymphoma (FL): A slow-growing type of lymphoma
  • Diffuse Large B-Cell Lymphoma (DLBCL): An aggressive type of lymphoma
  • Marginal Zone Lymphoma (MZL): A slow-growing lymphoma that develops in B-cells in the marginal zone of lymphoid tissue
  • Mantle Cell Lymphoma (MCL): A rare type of B-cell lymphoma
  • Other B-cell Non-Hodgkin Lymphomas (B-NHL)

Odronextamab is being tested in patients whose cancer has either come back after previous treatment (called “relapsed”) or has not responded to treatment (called “refractory”)[3][2].

Current Clinical Trials

Odronextamab is currently being studied in several clinical trials, including:

  • Phase 1 trials: These early studies are designed to test the safety and tolerability of odronextamab and determine the best dose to use[1].
  • Phase 3 trials: These larger studies compare odronextamab to standard treatments to see if it works better. For example:
    • OLYMPIA-1: Comparing odronextamab to rituximab plus chemotherapy in previously untreated follicular lymphoma[4].
    • OLYMPIA-2: Testing odronextamab with chemotherapy in previously untreated follicular lymphoma[5].
    • OLYMPIA-3: Comparing odronextamab plus chemotherapy to rituximab plus chemotherapy in previously untreated diffuse large B-cell lymphoma[6].
    • OLYMPIA-4: Evaluating odronextamab against standard care in relapsed/refractory aggressive B-cell non-Hodgkin lymphoma[7].
    • OLYMPIA-5: Comparing odronextamab plus lenalidomide to rituximab plus lenalidomide in relapsed/refractory follicular lymphoma and marginal zone lymphoma[8].

How is Odronextamab Administered?

Odronextamab is typically given as an intravenous (IV) infusion, which means it’s delivered directly into the bloodstream through a vein. The exact dosing schedule can vary depending on the specific clinical trial and the patient’s condition. Some studies are also exploring subcutaneous (under the skin) injections of odronextamab[1].

Potential Side Effects

As with any medication, odronextamab can cause side effects. The full range of potential side effects is still being studied, but some that researchers are monitoring include:

  • Cytokine release syndrome (CRS): A condition where the immune system becomes overactive, causing symptoms like fever, chills, and low blood pressure
  • Neurological effects: Such as headache or confusion
  • Infections: Due to changes in the immune system
  • Infusion-related reactions: Symptoms that occur during or shortly after receiving the IV infusion

It’s important to note that not all patients will experience these side effects, and researchers are working to find ways to manage and minimize them[2].

Future Research and Combinations

Researchers are also exploring how odronextamab might work in combination with other treatments. For example:

  • Combining odronextamab with chemotherapy to potentially improve its effectiveness[6].
  • Using odronextamab with lenalidomide, another drug used to treat certain blood cancers[8].
  • Studying odronextamab in combination with REGN5837 (another experimental drug) for aggressive B-cell lymphomas[9].
  • Investigating the combination of odronextamab with cemiplimab, an immunotherapy drug[10].

These studies aim to find the most effective ways to use odronextamab and potentially improve outcomes for patients with B-cell lymphomas.

Aspect Details
Drug Name Odronextamab (also known as REGN1979)
Drug Type Bispecific antibody targeting CD20 and CD3
Conditions Studied Follicular Lymphoma, Diffuse Large B-Cell Lymphoma, Marginal Zone Lymphoma, other B-cell Non-Hodgkin Lymphomas
Administration Intravenous (IV) infusion
Trial Phases Phase 1, Phase 3
Comparators Rituximab with chemotherapy (standard of care)
Key Outcomes Measured Safety, tolerability, objective response rate, complete response rate, progression-free survival, overall survival
Patient Populations Newly diagnosed, relapsed/refractory
Combination Therapies Chemotherapy (CHOP, CVP), lenalidomide, cemiplimab

FAQ

  • What is odronextamab? Odronextamab is an experimental bispecific antibody that targets both CD20 (found on B-cells) and CD3 (found on T-cells). It's designed to bring cancer-fighting T-cells into contact with cancerous B-cells in lymphomas.
  • What types of lymphoma is odronextamab being studied for? Odronextamab is being studied for various B-cell lymphomas, including follicular lymphoma, diffuse large B-cell lymphoma, marginal zone lymphoma, and other types of non-Hodgkin lymphoma.
  • How is odronextamab given to patients? Odronextamab is typically given as an intravenous (IV) infusion, meaning it's administered directly into the bloodstream through a vein.
  • What are some potential side effects of odronextamab? While specific side effects vary between trials, researchers are monitoring for dose-limiting toxicities, treatment-emergent adverse events, and effects on quality of life. Common side effects of cancer treatments may include fatigue, nausea, and changes in blood cell counts.
  • How do clinical trials measure if odronextamab is working? Trials use various measures to assess effectiveness, including objective response rate, complete response rate, progression-free survival, and overall survival. They also look at how long responses last and how the treatment affects patients' quality of life.

Ongoing Clinical Trials on Odronextamab

  • A study comparing odronextamab combined with chemotherapy versus rituximab combined with chemotherapy in adults with previously untreated follicular lymphoma

    Recruiting

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

  • Study of drug combination therapy in children and adolescents with relapsed or refractory B-cell non-Hodgkin lymphoma using odronextamab, loncastuximab tesirine and rituximab

    Recruiting

    1 1 1 1
    Investigated drugs:
    Austria Belgium France The Netherlands Spain Sweden

  • Study Comparing Odronextamab and Lenalidomide with Rituximab and Lenalidomide for Patients with Relapsed/Refractory Follicular and Marginal Zone Lymphoma

    Recruiting

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

  • Study on the Effectiveness and Safety of Odronextamab Compared to Standard Treatment in Adults with Relapsed or Refractory Aggressive B-cell Non-Hodgkin Lymphoma

    Not yet recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Austria Belgium Czechia Germany Hungary Italy +4

  • Study on the Effects and Safety of Odronextamab for Adults with Previously Treated B-cell Non-Hodgkin Lymphoma

    Not recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    France Germany Italy Poland Spain

  • Study Comparing Odronextamab with Rituximab and Chemotherapy for Patients with Untreated Follicular Lymphoma

    Not recruiting

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

Glossary

  • Bispecific antibody: A type of engineered antibody that can bind to two different targets at the same time, in this case CD20 on B-cells and CD3 on T-cells.
  • B-cell lymphoma: A type of cancer that starts in immune cells called B-cells, which are part of the body's lymphatic system.
  • Follicular lymphoma (FL): A slow-growing (indolent) type of non-Hodgkin lymphoma that starts in the B-cells of the immune system.
  • Diffuse large B-cell lymphoma (DLBCL): An aggressive type of non-Hodgkin lymphoma that grows and spreads quickly, but may respond well to treatment.
  • Relapsed/Refractory: Refers to cancer that has returned after treatment (relapsed) or did not respond to initial treatment (refractory).
  • Intravenous (IV) infusion: A method of delivering medication directly into a vein using a needle or catheter.
  • Dose-limiting toxicity (DLT): Side effects severe enough to prevent increasing the dose of a drug in a clinical trial.
  • Treatment-emergent adverse event (TEAE): Any unfavorable or unintended sign, symptom, or disease that appears or worsens after starting a medical treatment.
  • Objective response rate (ORR): The proportion of patients whose cancer shrinks or disappears after treatment.
  • Progression-free survival (PFS): The length of time during and after treatment that a patient lives without their cancer getting worse.
  • Overall survival (OS): The length of time from the start of treatment that patients are still alive.
  • Complete response (CR): The disappearance of all signs of cancer in response to treatment.
  • Anti-drug antibodies (ADA): Antibodies produced by the body against a medication, which can potentially reduce its effectiveness or cause side effects.
  • Standard of care: The best known treatment currently used for a specific condition or disease.
  • Chemotherapy: The use of drugs to destroy cancer cells, usually by stopping the cancer cells' ability to grow and divide.

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