Epcoritamab for Follicular Lymphoma

DC
Overseen ByDai Chihara, MD
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: M.D. Anderson Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

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.12345

Why 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?

DC

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

I am 18 years old or older.
Agree to refrain from donating blood while on study treatment, during dose interruptions and for at least 12 months following last dose
I have not received any systemic treatment for my lymphoma.
See 18 more

Exclusion Criteria

I have had lung inflammation needing steroids or currently have lung inflammation.
Life expectancy less than 6 months
Psychiatric illness or social situations limiting compliance with study requirements
See 16 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the study drug epcoritamab or are monitored under watchful waiting

1 year

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

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

Group I: OBS ArmExperimental Treatment1 Intervention
Group II: EPCORI ArmExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials
3,107
Recruited
1,813,000+

Genmab

Industry Sponsor

Trials
76
Recruited
15,300+

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 ...

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/41371238/

Epcoritamab, lenalidomide, and rituximab versus ...

Epcoritamab plus R2 resulted in significantly higher response rate and longer progression-free survival versus R2 among participants with ...

Fixed-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 ...

Epcoritamab 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, ...

Epcoritamab Plus Lenalidomide/Rituximab Wins EU ...

Safety was consistent with component agents; common toxicities included neutropenia, infections, rash, fatigue, diarrhea, injection reactions, ...