Figure from: https://www.empr.com/home/news/epkinly-approved-for-relapsed-refractory-diffuse-large-b-cell-lymphoma/
Introduction:
AbbVie's groundbreaking epcoritamab is leading the charge in follicular lymphoma (FL) treatment, securing Breakthrough Therapy Designation (BTD) from the U.S. Food and Drug Administration (FDA) and obtaining Type II application validation from the European Medicines Agency (EMA). This in-depth exploration not only emphasizes these significant milestones but also meticulously compares epcoritamab with key competitors, delving into details from the original article.
Breaking New Ground: Regulatory Triumphs for Epcoritamab Epcoritamab, an investigational therapy for relapsed or refractory FL, has achieved FDA BTD and EMA validation, signifying its potential to redefine treatment standards.
Comparative Analysis: Epcoritamab in Context
Background on Follicular Lymphoma (FL) for Healthcare Professionals:
Follicular Lymphoma (FL) constitutes a prevalent subtype of non-Hodgkin lymphomas (NHL), representing approximately 20-30% of all NHL cases worldwide. Characterized by the slow and progressive growth of abnormal B cells, FL manifests in the formation of small nodules or follicles in various components of the lymphatic system. Despite its indolent nature, FL poses a significant clinical challenge as the second most common NHL, deemed incurable with existing standard-of-care therapies. The chronic course of FL, potential for transformation, and impact on patients' quality of life underscore the importance of informed decision-making by healthcare professionals. Ongoing research efforts focus on unraveling the molecular intricacies of FL, facilitating the development of novel therapeutic strategies to address this unmet medical need. In this context, Epcoritamab, a T-cell engaging bispecific antibody, emerges as a promising investigational approach, offering healthcare professionals a potential breakthrough in the complex landscape of follicular lymphoma treatment.
Mechanism of Action:
Epcoritamab (AbbVie/Genmab): Deploys T-cell engaging bispecific antibody technology, targeting CD3 on T cells and CD20 on B cells, facilitating T-cell-mediated killing of CD20+ cells.
Polatuzumab Vedotin (Roche): Utilizes an antibody-drug conjugate delivering a cytotoxic agent specifically to CD79b-expressing B cells.
Administration Route:
Epcoritamab: Subcutaneous administration introduces a groundbreaking outpatient dosing option.
Polatuzumab Vedotin: Intravenous administration traditionally involves hospital visits.
Breakthrough Therapy Designation (BTD):
Epcoritamab: Acknowledged by the FDA with BTD, signaling potential substantial improvements over existing therapies.
Polatuzumab Vedotin: FDA-approved, demonstrating efficacy in specific lymphoma patient populations.
Global Collaboration and Commercial Responsibilities:
Epcoritamab (AbbVie/Genmab): A collaborative effort shared by AbbVie and Genmab, managing commercial responsibilities in the U.S. and Japan.
Polatuzumab Vedotin (Roche): Globally marketed by Roche, a prominent player in the oncology space.
Clinical Trial Program:
Epcoritamab: Phase 1/2 EPCORE™ NHL-1 trial involving 128 adult patients, evaluating safety, and preliminary efficacy, featuring an optimized dosing schedule.
Polatuzumab Vedotin: Subject to clinical trials, including the pivotal POLARIX trial focused on relapsed or refractory diffuse large B-cell lymphoma.
Clinical Information from Original Article:
FDA BTD positions epcoritamab as a potential core therapy for multiple B-cell malignancies.
FL, the second most common form of NHL, presents an unmet medical need despite being considered incurable with current therapies.
Epcoritamab, created using Genmab's DuoBody® technology, simultaneously binds to CD3 on T cells and CD20 on B cells, offering a novel approach to targeting lymphoma cells.
Side Effects:
Epcoritamab:
Common: Cytokine Release Syndrome (CRS), tiredness, muscle and bone pain, injection site reactions, fever, abdominal pain, nausea, diarrhea.
Serious: Neurologic problems (trouble speaking, confusion, seizures, memory loss), serious infections, low blood cell counts.
Polatuzumab Vedotin:
Common: Not specified.
Serious: Not specified.
Unlocking Hope for Challenging Cases: Epcoritamab's Breakthrough in Relapsed/Refractory Follicular Lymphoma
AbbVie and Genmab have unveiled compelling data from the Phase 1/2 EPCORE™ NHL-1 study, showcasing the remarkable efficacy of epcoritamab (DuoBody® CD3xCD20) in adult patients grappling with relapsed/refractory (R/R) follicular lymphoma (FL). The study, presented at the 65th American Society of Hematology (ASH) congress, revealed an impressive 82% overall response rate (ORR), with 63% of patients achieving complete response (CR). Administered subcutaneously, epcoritamab demonstrated high efficacy in patients previously treated with two or more therapies, offering a beacon of hope in a challenging treatment landscape.
This groundbreaking data provides a glimpse into the potential of epcoritamab as a transformative treatment option for patients facing the challenging landscape of R/R FL. The study's median follow-up of 17.4 months unveiled encouraging statistics, with a median time to response and CR recorded at 1.4 months and 1.5 months, respectively. Furthermore, patients refractory to prior treatments, including those categorized as double refractory (70%), demonstrated response rates consistent with the overall study population.
"Despite treatment advances for patients with follicular lymphoma whose disease has unfortunately progressed, treating relapsed or refractory follicular lymphoma remains highly challenging, particularly as a third-line treatment," -- said Catherine Thieblemont, M.D., Ph.D., head of the hemato-oncology department, Paris University, Hôpital Saint-Louis Assistance-Publique-Hopitaux de Paris (APHP)
The data also shed light on the optimized step-up dosing schedule, showcasing a reduction in the incidence and severity of cytokine release syndrome (CRS), a common side effect associated with immune-engaging cancer therapies. Notably, no new safety signals were identified, emphasizing the favorable safety profile of epcoritamab.
Conclusion:
Epcoritamab's regulatory triumphs and unique attributes, highlighted in this comparative analysis, underscore its potential to redefine FL treatment. As we contrast it with competitors like Polatuzumab Vedotin, epcoritamab's innovative mechanisms, subcutaneous administration, and collaborative development model emerge as differentiators. With a comprehensive clinical trial program, epcoritamab stands poised as a potential game-changer in the evolving landscape of lymphoma therapies, offering renewed hope for patients and clinicians alike.
Resources:
Lymphoma Research Foundation official website. https://lymphoma.org/aboutlymphoma/nhl/fl/. Accessed November 2023.
Ma S. Risk factors of follicular lymphoma. Expert Opin Med Diagn. 2012;6:323–33. doi: 10.1517/17530059.2012.686996.
Luminari S, Bellei M, Biasoli I, Federico M. Follicular lymphoma—treatment and prognostic factors. Rev Bras Hematol Hemoter. 2012;34:54–9. doi: 10.5581/1516-8484.20120015.
Link BK, et al. Second-Line and Subsequent Therapy and Outcomes for Follicular Lymphoma in the United States: Data From the Observational National LymphoCare Study. Br J Haematol 2019;184(4):660-663.
Ren J, et al. Economic Burden and Treatment Patterns for Patients With Diffuse Large B-Cell Lymphoma and Follicular Lymphoma in the USA. J Comp Eff Res 2019;8(6):393-402.
Lymphoma Research Foundation official website. https://lymphoma.org/understanding-lymphoma/aboutlymphoma/nhl/follicular-lymphoma/relapsedfl/. Accessed November 2023.
Engelberts PJ, Hiemstra IH, de Jong B, et al. DuoBody-CD3xCD20 induces potent T-cell-mediated killing of malignant B cells in preclinical models and provides opportunities for subcutaneous dosing. EBioMedicine. 2020;52:102625. DOI: 10.1016/j.ebiom.2019.102625. SOURCE AbbVie
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