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Belinostat for the treatment of peripheral T-cell lymphomas
1Division of Medical Oncology, Department of Medicine, University of Colorado School of Medicine, Aurora, Colorado, USA.
Abstract:
Belinostat is a novel histone deacetylase (HDAC) inhibitor that is being developed in various solid tumors and hematologic malignancies. HDACs have been found to be important in the epigenetic regulation of cancer progression and inhibition of these molecules in preclinical studies induces cancer cell apoptosis and prevents tumor growth. Several HDAC molecules have been found to be overexpressed in peripheral T-cell lymphoma (PTCL) and therefore HDAC inhibition has been an important new target in treating these malignancies which have traditionally had poor outcomes and limited treatment response. Phase I studies were tested across a broad range of hematologic and solid tumors and showed stability of disease in various tumor types with low rates of adverse events. This made it acceptable to proceed with further testing in specific tumor types to further determine efficacy. Two phase II studies have been completed with belinostat given intravenously in the relapsed/refractory PTCL setting with at least 25% overall response and minimal toxicities. These findings have led to a request for accelerated approval to the U.S. Food and Drug Administration for belinostat in this setting. This review will discuss the preclinical pharmacology, pharmacokinetics and clinical efficacy to date of belinostat in the treatment of PTCL.
Insights
Belinostat, a novel histone deacetylase (HDAC) inhibitor, shows promise in treating peripheral T-cell lymphoma (PTCL). Clinical trials demonstrate significant response rates with minimal toxicity, supporting its potential as a new therapy for this challenging malignancy.
Area of Science:
- Oncology
- Epigenetics
- Pharmacology
Background:
- Histone deacetylase (HDAC) inhibitors represent a novel therapeutic strategy targeting epigenetic dysregulation in cancer.
- Peripheral T-cell lymphoma (PTCL) is a group of aggressive non-Hodgkin lymphomas with historically poor prognoses and limited treatment options.
- Overexpression of HDACs in PTCL suggests HDAC inhibition as a rational therapeutic approach.
Purpose of the Study:
- To review the preclinical pharmacology, pharmacokinetics, and clinical efficacy of belinostat for the treatment of PTCL.
- To evaluate the potential of belinostat as an accelerated approval candidate for relapsed/refractory PTCL.
Main Methods:
- Review of preclinical data on belinostat's mechanism of action and anti-cancer effects.
- Analysis of Phase I studies assessing safety and disease stability across various tumor types.
- Evaluation of Phase II study results focusing on efficacy (overall response rate) and toxicity in relapsed/refractory PTCL patients.
Main Results:
- Belinostat demonstrated anti-cancer activity in preclinical models, including induction of apoptosis and inhibition of tumor growth.
- Phase I studies indicated acceptable safety and disease stability in diverse malignancies.
- Two Phase II studies in relapsed/refractory PTCL reported an overall response rate of at least 25% with minimal toxicities.
Conclusions:
- Belinostat exhibits promising efficacy and a favorable safety profile in patients with relapsed/refractory PTCL.
- These findings support the ongoing development and potential accelerated approval of belinostat for PTCL treatment.
- HDAC inhibition with belinostat represents a significant advancement in the therapeutic landscape for PTCL.
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