All content on this site is intended for healthcare professionals only. By acknowledging this message and accessing the information on this website you are confirming that you are a Healthcare Professional. If you are a patient or carer, please visit the Lymphoma Coalition.
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
FDA provides positive feedback in end of phase II meeting for BNZ-1 for patients with refractory cutaneous T-cell lymphoma
On January 4, 2021, it was announced that the U.S. Food and Drug Administration (FDA) provided positive feedback in the end of phase II meeting for BNZ-1, a multi-cytokine inhibitor, for the treatment of refractory cutaneous T-cell lymphoma.1 The completed phase II trial data were also presented at the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition and are an update on those previously reported on Lymphoma Hub.2
NCT03239392 was a multicenter, open label, phase I/II study to evaluate the efficacy and safety of BNZ‑1 in patents with refractory cutaneous T-cell lymphoma that had failed up to seven prior therapies. Initial dose escalation (n = 15) resulted in selection of the 2 mg/kg dose, based on the pharmacokinetic/pharmacodynamic relationship and clinical efficacy, and the cohort was subsequently expanded (n = 19).2
The primary endpoint of the study was overall safety after 4 weeks of treatment. A treatment extension of 3 months was required to further evaluate safety and clinical response at week 17, and long-term extension of over a year was available for those who benefited from BNZ-1 treatment (n = 12).2
The overall response rate for the expanded cohort was 63.2%, as measured by the global response score. Positive response typically occurred soon after treatment initiation, which persisted for the duration of treatment, with 10% of patients reaching a partial response as early as 4 weeks after the initial dose. Stable disease was seen in 37% of patients. No disease recurrence or relapse was observed during the study period. BNZ-1 treatment was well tolerated with no dose-limiting toxicities or drug-related serious adverse effects. BNZ-1 also demonstrated a dose-dependent reduction of regulatory T‑cells.2
Based on these results and the FDA’s feedback, a phase III clinical trial will be initiated in this subset of patients. The FDA provided clear guidance for the design of this pivotal trial; therefore, enrollment is expected to begin in the second half of 2021.1
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
Your opinion matters
What types of support services or resources do you think would best facilitate the safe implementation of the BrECADD regimen in clinical practice?