Epkinly (epcoritamab)

To treat relapsed or refractory diffuse large B-cell lymphoma (not otherwise specified) and high-grade B-cell lymphoma after two or more lines of systemic therapy Drug Trials Snapshots

FDA Approval: 5/19/2023

Research Synopsis

  • Epcoritamab (brand name Epkinly) is a bispecific antibody designed to treat B-cell non-Hodgkin lymphoma (B-NHL) by targeting CD20 tumor cells and engaging T-cells.
  • It has shown significant anti-tumor activity against malignant B-cells from patients with various types of lymphoma including diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL), with tumor lysis rates between 65-84% in preclinical studies.
  • In clinical trials, epcoritamab demonstrated a 63.1% overall response rate and a 38.9% complete response rate in patients with relapsed or refractory large B-cell lymphoma.
  • A recommended phase 2 dose of 48 mg was identified, exhibiting manageable side effects such as mild fever and injection site reactions without severe adverse events.
  • Response rates differ based on lymphoma type, with 68% response in DLBCL and a higher 90% response in patients with FL, highlighting its potential differentiation in effectiveness.
  • Epcoritamab has been involved in innovative dosing strategies and studies utilizing advanced pharmacokinetic/pharmacodynamic modeling to optimize efficacy while minimizing side effects.
  • The drug is part of a growing trend towards targeted therapies in oncology, emphasizing immune engagement over traditional chemotherapy approaches.
  • Clinical research continues to explore its use in combination therapies, notably with BTK inhibitors, to enhance treatment outcomes in chronic lymphocytic leukemia (CLL) and other hematological malignancies.
  • Epcoritamab has received FDA approval and its rapid integration into treatment regimens marks a significant advancement for patients with challenging relapsed or refractory B-cell lymphomas.

Related articles

Research articles about Epkinly (epcoritamab)

Epkinly (epcoritamab)

Epcoritamab induces potent anti-tumor activity against malignant B-cells from patients with DLBCL, FL and MCL, irrespective of prior CD20 monoclonal antibody treatment.

London, UK

2 hours ago

1 Received

  • Epcoritamab is a new bispecific antibody that helps T-cells target CD20 tumor cells in B-cell non-Hodgkin lymphoma (B-NHL).
  • In preclinical studies, it effectively killed primary tumor cells from both newly diagnosed and relapsed/refractory B-NHL patients, achieving 65-84% tumor lysis across different lymphoma types.
  • The study found that T-cell activation varied among tumor cells and was negatively related to the levels of the immune checkpoint molecule HVEM, indicating that epcoritamab could be a promising treatment even for patients who did not respond to previous CD20 therapies.

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Dose escalation of subcutaneous epcoritamab in patients with relapsed or refractory B-cell non-Hodgkin lymphoma: an open-label, phase 1/2 study.

London, UK

2 hours ago

1 Received

  • A study has been conducted to evaluate the safety and optimal dosage of epcoritamab, a bispecific antibody targeting CD3 and CD20, for treating patients with relapsed or refractory B-cell non-Hodgkin lymphoma.
  • Conducted across four countries, 73 adults participated, receiving escalating doses of the drug, with 68 patients completing the regimen without reaching maximum toxic limits.
  • Results showed that the recommended phase 2 dose is 48 mg, with manageable side effects predominantly including mild fever and injection site reactions, and no severe adverse events or treatment-related deaths reported.

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Promising Immunotherapeutic Modalities for B-Cell Lymphoproliferative Disorders.

London, UK

2 hours ago

1 Received

  • Recent advancements in treating B-cell lymphoma and chronic lymphocytic leukemia (CLL) have shifted towards targeted therapies, particularly immunotherapeutics.
  • These therapies utilize B-cell-associated antigens, such as CD19 and CD20, and include monoclonal antibodies, bispecific antibodies, and CAR-T cell therapy to enhance treatment efficacy.
  • Bispecific T-cell engagers (TCEs) show promise, especially anti-CD20xCD3, while antibody-drug conjugates targeting various B-cell antigens demonstrate effectiveness when used with other treatments, warranting further research into their potential to replace traditional chemotherapy.

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The Bispecific Antibody Epcoritamab Produces Responses in Lymphoma.

London, UK

2 hours ago

1 Received

  • * A higher response rate of 90% was observed in patients with follicular lymphoma.
  • * These statistics indicate varying effectiveness of treatment between the two types of lymphoma.

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Bispecific Antibodies for Non-Hodgkin Lymphoma Treatment.

London, UK

2 hours ago

1 Received

  • Despite advancements in non-Hodgkin lymphoma (NHL) treatment, relapsed and refractory cases still pose significant challenges, highlighting the need for better therapies.
  • T-cell redirecting immunotherapies, particularly bispecific antibodies (BsAbs), show great promise for NHL by targeting both T-cells and malignant B-cells, with newer agents like odronextamab and mosunetuzumab demonstrating favorable safety and efficacy profiles.
  • Ongoing studies aim to address key questions about the optimal use of BsAbs in treatment plans, their potential in newly diagnosed cases, and their effectiveness when combined with other treatments, including CAR T-cell therapy.

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Immunotherapy in indolent Non-Hodgkin's Lymphoma.

London, UK

2 hours ago

1 Received

  • - The treatment options for non-Hodgkin lymphoma (NHL) have improved with the introduction of monoclonal antibody (MAB) therapy, particularly focusing on B cell and T cell subtypes, and categorized into aggressive and indolent forms.
  • - Rituximab, an anti-CD20 MAB, revolutionized treatment for indolent B cell NHL, like follicular lymphoma, by directly targeting cancerous B cells and becoming FDA approved in 1997.
  • - Despite its effectiveness, challenges such as resistance mechanisms have prompted interest in combining immunotherapy with radio-sensitizing agents, leading to advancements in drugs like 90Y-ibritumomab tiuxetan and ofatumumab

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Role of Bispecific Antibodies in Relapsed/Refractory Diffuse Large B-Cell Lymphoma in the CART Era.

London, UK

2 hours ago

1 Received

  • Diffuse large B-cell lymphoma is a severe type of cancer with varying biological behavior, treated primarily with R-CHOP, which successfully cures over 60% of patients.
  • For patients who relapse, high-dose chemotherapy and stem cell transplants are the standard approach, with newer treatments like CD19 CAR T-cells recently approved for certain cases.
  • Bispecific antibodies (BsAbs), designed to target CD20 on B cells while engaging T cells, show promising results in clinical trials, offering a favorable safety profile and potential effectiveness even in aggressive lymphomas, with ongoing research to further evaluate their use.

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[Current status and future prospects of diffuse large B-cell lymphoma treatment].

London, UK

2 hours ago

1 Received

  • R-CHOP therapy, which includes components like rituximab and doxorubicin, has been the go-to treatment for newly diagnosed diffuse large B-cell lymphoma (DLBCL) since the early 2000s.
  • New therapies such as polatuzumab vedotin and CAR-T therapy are now available for patients whose DLBCL has relapsed or doesn’t respond to initial treatments.
  • Several emerging treatment options, including bispecific antibodies and new drug combinations, are currently being explored to improve outcomes for DLBCL patients in Japan.

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Semimechanistic Physiologically-Based Pharmacokinetic/Pharmacodynamic Model Informing Epcoritamab Dose Selection for Patients With B-Cell Lymphomas.

London, UK

2 hours ago

1 Received

  • Epcoritamab is a bispecific antibody targeting CD3 and CD20, designed to activate T cells to kill cancerous B cells and is currently in a phase I/II clinical trial to find the safest and most effective dose.
  • The trial involves a unique pharmacokinetic/pharmacodynamic model to better predict how the drug interacts with the body and how it influences tumor response, rather than using traditional modeling methods which may not be sufficient.
  • Results indicate that a dose of 48 mg optimally triggers T cell responses in conditions like diffuse large B-cell lymphoma and follicular lymphoma without significantly increasing the risk of cytokine release syndrome.

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Epcoritamab is active in large B cell lymphomas.

London, UK

2 hours ago

1 Received

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Epcoritamab, a Novel, Subcutaneous CD3xCD20 Bispecific T-Cell-Engaging Antibody, in Relapsed or Refractory Large B-Cell Lymphoma: Dose Expansion in a Phase I/II Trial.

London, UK

2 hours ago

1 Received

  • Epcoritamab is a bispecific antibody that helps T cells attack and kill malignant B cells, showing strong results in treating B-cell non-Hodgkin lymphoma during previous trials.
  • In a phase I/II study, patients with relapsed or refractory large B-cell lymphoma received weekly doses of epcoritamab for up to several months to assess its effectiveness.
  • Results showed a 63.1% overall response rate and 38.9% complete response rate among 157 patients with manageable side effects, suggesting it is a promising treatment for difficult cases of lymphoma.

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Epcoritamab (Epkinly) for diffuse large B-cell lymphoma (DLBCL).

London, UK

2 hours ago

1 Received

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Epcoritamab-bysp (Epkinly) - A phenomenal breakthrough in the treatment of diffuse large B-cell lymphoma.

London, UK

2 hours ago

1 Received

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Bi- and trispecific immune cell engagers for immunotherapy of hematological malignancies.

London, UK

2 hours ago

1 Received

  • Immune cell engagers are specialized antibodies designed to target tumor-associated antigens and activate immune cells, particularly T cells and NK cells, with notable examples approved recently being mosunetuzumab, epcoritamab, and teclistamab.
  • The potential of these T cell engagers is significant, as they are more effective than traditional monoclonal antibodies in treating blood cancers, with an increasing number of agents in clinical trials.
  • Advanced formats like bispecific and trispecific antibodies are emerging, promising to further enhance targeting capabilities and effectiveness while potentially reducing side effects in cancer treatments.

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Glofitamab (Columvi) for diffuse large B-cell lymphoma.

London, UK

2 hours ago

1 Received

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CD20 × CD3 bispecific antibodies for lymphoma therapy: latest updates from ASCO 2023 annual meeting.

London, UK

2 hours ago

1 Received

  • Multiple bispecific antibodies (bsAbs) have been approved for cancer immunotherapy, specifically targeting B-cell non-Hodgkin lymphoma (NHL).
  • CD20 × CD3 bsAbs, like mosunetuzumab, epcoritamab, and glofitamab, have shown significant effectiveness in engaging T cells to attack CD20-positive NHL cells during clinical trials.
  • This study highlights recent findings on CD20 × CD3 bsAbs presented at the ASCO 2023 annual meeting regarding their use in treating B-cell NHL.

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Real-world experience among patients with relapsed/refractory mantle cell lymphoma after Bruton tyrosine kinase inhibitor failure in Europe: The SCHOLAR-2 retrospective chart review study.

London, UK

2 hours ago

1 Received

  • * Data collected from 240 patients in Europe indicates a median overall survival of 14.6 months following the start of initial BTKi therapy, with varying outcomes based on subsequent treatments.
  • * Patients who received further therapy after BTKi failure had a median overall survival of 23.8 months, particularly with lenalidomide and bendamustine plus rituximab, providing a new benchmark for treatment effectiveness.

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Cytotoxicity of the CD3×CD20 bispecific antibody epcoritamab in CLL is increased by concurrent BTK or BCL-2 targeting.

London, UK

2 hours ago

1 Received

  • Chronic lymphocytic leukemia (CLL) is a challenging disease that leads to a weakened immune system and makes patients more prone to infections and less responsive to immunotherapies; however, new treatments with BTK inhibitors and venetoclax have shown promise in improving outcomes.
  • Epcoritamab, a bispecific antibody that targets both CD3 and CD20, has shown strong clinical effects in treating relapsed non-Hodgkin lymphoma and is being studied for its potential to enhance CLL therapy, particularly when combined with existing treatments.
  • Research indicates that epcoritamab promotes T-cell activity and can effectively reduce CLL cellular presence in mouse models, making it a promising candidate for combination therapy with BTK inhibitors

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Update on bi-specific monoclonal antibodies for blood cancers.

London, UK

2 hours ago

1 Received

  • - The review highlights recent advancements in bispecific antibodies, particularly those approved for treating multiple myeloma, follicular lymphoma, and diffuse large B cell lymphoma.
  • - Key bispecific antibodies like Teclistamab, Mosunetuzumab, Epcoritamab, and glofitamab have shown promising efficacy and tolerability in heavily treated patients, despite some manageable toxicity issues.
  • - These bispecific antibodies are expected to significantly impact the treatment of hematologic cancers, with FDA approval for Epcoritamab in the U.S. and glofitamab approved in Canada for specific cases.

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