A Phase II trial of Belinostat (PXD101) in patients with relapsed or refractory peripheral or cutaneous T-cell...

Area of Science:

• Oncology
• Pharmacology
• Clinical Trials

Background:

• Belinostat is a pan-histone deacetylase inhibitor with demonstrated antitumour and anti-angiogenic effects.
• Peripheral T-cell lymphoma (PTCL) and cutaneous T-cell lymphoma (CTCL) are types of non-Hodgkin lymphoma with limited treatment options for refractory or relapsed cases.

Purpose of the Study:

• To evaluate the efficacy and safety of belinostat monotherapy in patients with relapsed or refractory PTCL or CTCL.
• To determine the objective response rate (ORR) as the primary endpoint.

Main Methods:

• An open-label, multicenter study treated patients with belinostat (1000 mg/m² intravenously for 5 days every 21 days).
• Patients included those with PTCL (n=24) or CTCL (n=29) who had failed at least one prior systemic therapy.
• The study monitored treatment-related adverse events and serious adverse events.

Main Results:

• The ORR was 25% in PTCL patients and 14% in CTCL patients.
• Treatment-related adverse events occurred in 77% of patients, with nausea and vomiting being most common.
• Serious adverse events included Grade 5 ventricular fibrillation and Grade 4 thrombocytopenia.

Conclusions:

• Belinostat monotherapy demonstrated efficacy in patients with recurrent or refractory PTCL and CTCL.
• The drug was generally well-tolerated, suggesting a favorable risk-benefit profile for this patient population.
• Further investigation into belinostat's role in T-cell lymphoma treatment is warranted.