The lym Hub website uses a third-party service provided by Google that dynamically translates web content. Translations are machine generated, so may not be an exact or complete translation, and the lym Hub cannot guarantee the accuracy of translated content. The lym and its employees will not be liable for any direct, indirect, or consequential damages (even if foreseeable) resulting from use of the Google Translate feature. For further support with Google Translate, visit Google Translate Help.
The Lymphoma & CLL Hub is an independent medical education platform, sponsored by Beigene, Johnson & Johnson and Roche, and supported through educational grants from Bristol Myers Squibb, Incyte, Lilly, and Pfizer. View funders.
Now you can support HCPs in making informed decisions for their patients
Your contribution helps us continuously deliver expertly curated content to HCPs worldwide. You will also have the opportunity to make a content suggestion for consideration and receive updates on the impact contributions are making to our content.
Find out more
Create an account and access these new features:
Bookmark content to read later
Select your specific areas of interest
View lym content recommended for you
Epcoritamab-bysp receives accelerated U.S. FDA approval for the treatment of R/R FL
On June 26, 2024, the U.S. Food and Drug Administration (FDA) granted accelerated approval to epcoritamab-bysp, an off-the-shelf bispecific CD-20-directed CD3 T-cell engager, for the treatment of adults with relapsed and/or refractory (R/R) follicular lymphoma (FL), following ≥2 lines of systemic therapy. The approval was based on positive results from the EPCORE NHL-1 trial.1,2
The EPCORE NHL-1 trial
EPCORE NHL-1 trial is an open-label, multi-cohort, multicenter, phase I/II trial (NCT03625037), investigating the safety and preliminary efficacy of epcoritamab-bysp in adults with R/R FL after ≥2 lines of systemic therapy.1,2
Among 127 patients receiving a 2-step-up dosing regimen:1,2
-
Overall response rate was 82% (95% confidence interval [CI], 74.1%−88.2%), and complete response rate was 60%.
-
12-month Kaplan-Meier estimate for duration of response was 68.4% (95% CI, 57.6%−77.0%).
Efficacy was similar in the 86 patients receiving the recommended 3-step-up dosing regimen for mitigating cytokine release syndrome (CRS).1
The most commonly reported adverse reactions in ≥20% of patients were injection site reactions, CRS, COVID-10 infection, fatigue, upper respiratory tract infection, musculoskeletal pain, rash, diarrhea, pyrexia, cough, and headache.1,2 The prescribing information comes with a boxed warning for serious or fatal CRS and immune effector cell-associated neurotoxicity.1,2
A phase III randomized trial (NCT05409066) is currently ongoing to investigate epcoritamab-bysp in combination with rituximab and lenalidomide in patients with R/R FL.1,2
References
Please indicate your level of agreement with the following statements:
The content was clear and easy to understand
The content addressed the learning objectives
The content was relevant to my practice
I will change my clinical practice as a result of this content
