Epcoritamab for Follicular Lymphoma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to evaluate the effectiveness of a new treatment, epcoritamab, for individuals with follicular lymphoma, a type of blood cancer. Researchers seek to determine if this treatment can delay the need for additional therapy compared to simply monitoring the condition. Participants should have untreated follicular lymphoma with low cancer activity, without severe symptoms or large tumors. This trial provides a potential new treatment path for those seeking to manage their condition more effectively. As a Phase 2 trial, the research focuses on assessing the treatment's efficacy in an initial, smaller group, offering participants an opportunity to contribute to significant findings.
Is there any evidence suggesting that epcoritamab is likely to be safe for humans?
Previous studies have shown that epcoritamab has a manageable safety profile for patients with follicular lymphoma, a type of blood cancer. Patients experienced common side effects, such as low white blood cell count, infections, rash, tiredness, and diarrhea. Reports also included reactions at the injection site.
Most side effects aligned with existing knowledge about the drug, and no unexpected safety issues emerged. However, some patients experienced cytokine release syndrome (CRS), a potentially serious immune reaction.
Overall, the safety data suggest that epcoritamab is generally well-tolerated, but like any treatment, it carries risks. Participants should discuss these with their healthcare providers.12345Why do researchers think this study treatment might be promising?
Epcoritamab is unique because it employs a novel mechanism of action known as bispecific T-cell engager (BiTE) technology. This approach allows Epcoritamab to simultaneously bind to CD3 on T cells and CD20 on B cells, directing the immune system to target and destroy cancerous B cells more effectively. Unlike traditional treatments for follicular lymphoma, which often include chemotherapy and monoclonal antibodies like rituximab, Epcoritamab offers a more targeted attack on cancer cells with potentially fewer side effects. Researchers are excited about Epcoritamab because it represents a promising advance in cancer immunotherapy, potentially improving outcomes for patients with this type of lymphoma.
What evidence suggests that epcoritamab might be an effective treatment for follicular lymphoma?
Studies have shown promising results for epcoritamab in treating follicular lymphoma. One study reported an overall response rate of 84.6% with epcoritamab alone, with 67.1% of patients achieving a complete response. This indicates that most patients experienced a reduction or disappearance of their cancer. In this trial, participants in the EPCORI Arm will receive epcoritamab. Furthermore, when combined with other treatments, epcoritamab improved response rates and prolonged remission. These findings suggest that epcoritamab could effectively manage follicular lymphoma.56789
Who Is on the Research Team?
Dai Chihara, MD
Principal Investigator
UT MD Anderson Cancer Center
Are You a Good Fit for This Trial?
This trial is for adults (18+) recently diagnosed with low tumor burden follicular lymphoma who have not had any prior treatment. Participants must be in generally good health, have adequate organ function, and agree to use contraception if of childbearing potential. People with certain infections, other cancers, or serious medical conditions cannot join.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive the study drug epcoritamab or are monitored under watchful waiting
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Epcoritamab
Trial Overview
The study compares the effects of a new drug called epcoritamab versus watchful waiting (no immediate treatment) in people with untreated, low-burden follicular lymphoma. Patients are randomly assigned to either receive the drug or just be monitored.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Find a Clinic Near You
Who Is Running the Clinical Trial?
M.D. Anderson Cancer Center
Lead Sponsor
Genmab
Industry Sponsor
Dr. Jan van de Winkel
Genmab
Chief Executive Officer since 2010
PhD in Immunology, University of Utrecht
Dr. Judith Klimovsky
Genmab
Chief Medical Officer since 2019
MD, University of Copenhagen
Citations
3L+ FL Clinical Trial Results
Even with a high enrollment of patients with difficult-to-treat disease,* 60% CR was observed in EPCORE® NHL-11-4. 82% of patients had a response (n equals ...
Epcoritamab, lenalidomide, and rituximab versus ...
Epcoritamab plus R2 resulted in significantly higher response rate and longer progression-free survival versus R2 among participants with ...
3.
ashpublications.org
ashpublications.org/blood/article/146/22/2629/547148/Fixed-duration-epcoritamab-plus-R2-drivesFixed-duration epcoritamab plus R2 drives favorable ...
In the phase 3 AUGMENT trial, R2 resulted in an overall response rate (ORR) of 78% and complete response (CR) rate of 34% in patients with R/R ...
Genmab Presents EPCORE® FL-1 Subgroup Data ...
The data demonstrated that progression-free survival (PFS) benefits continued to favor epcoritamab + R2, with hazard ratios (HR) consistently below 0.3 across ...
Epcoritamab Improves Outcomes, HRQOL in Patients With ...
Epcoritamab monotherapy achieved high overall (84.6%) and complete response rates (67.1%) in relapsed/refractory follicular lymphoma patients ...
Epcoritamab, lenalidomide, and rituximab versus ...
Adverse events were manageable and consistent with the established safety profiles of the individual components, with no new safety findings ...
7.
rs-os-lyh-dt-publicread-file-bosmetadata-prod.liangyihui.net
rs-os-lyh-dt-publicread-file-bosmetadata-prod.liangyihui.net/boss-upload/3cQ8Vj5muMvRjAYRc2Zs4A/rLO19vJ9298kScLA.pdfEpcoritamab monotherapy in patients with relapsed or ...
Epcoritamab demonstrated clinically meaningful activity with manageable safety in patients with relapsed or refractory follicular lymphoma after ...
Epcoritamab for treating relapsed or refractory follicular ... - NCBI
Epcoritamab can be used as an option to treat relapsed or refractory follicular lymphoma in adults after 2 or more lines of systemic treatment, ...
9.
onclive.com
onclive.com/view/epcoritamab-plus-lenalidomide-rituximab-win-eu-approval-for-r-r-follicular-lymphomaEpcoritamab Plus Lenalidomide/Rituximab Wins EU ...
Safety was consistent with component agents; common toxicities included neutropenia, infections, rash, fatigue, diarrhea, injection reactions, ...
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