Belinostat Monotherapy Safe, Effective for T-cell Lymphoma

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Belinostat, a novel histone deacetylase inhibitor, showed efficacy in relapsed or refractory PTCL.
Belinostat, a novel histone deacetylase inhibitor, showed efficacy in relapsed or refractory PTCL.

Belinostat is a novel histone deacetylase inhibitor that showed efficacy in patients with relapsed or refractory peripheral T-cell lymphomas (PTCLs), according to the BELIEF study published online ahead of print this week in the Journal of Clinical Oncology.

The study was a single-arm, pivotal phase 2 trial with a total of 129 patients who were assigned to belinostat monotherapy for five days in every 21-day cycle.

The patients were confirmed to have PTCL with disease progression even after receiving at least one prior therapy.

The primary endpoint was overall response rate (ORR), and secondary end points were duration of response (DoR), progression-free survival (PFS), and overall survival (OS). 

Results showed that in the 120 evaluable patients, ORR was 25.8% with complete and partial response of 10.8% and 15%, respectively.

The median DoR was 13.6 months, and the longest ongoing DoR was greater than or equal to 36 months. The median PFS was 1.6 months and OS was 7.9 months.

RELATED: Treatments for Diffuse Large B-cell Lymphoma in Elderly Patients

The most common grade 3 to 4 adverse events included anemia (10.8%), thrombocytopenia (7%), dyspnea (6.2%), and neutropenia (6.2%).

This study led belinostat to gain approval from the U.S. Food and Drug Administration (FDA) as the study demonstrated efficacy with manageable adverse events in relapsed or refractory PTCLs. 

Reference

  1. O'Connor OA, Horwitz S, Masszi T, et al. Belinostat in patients with relapsed or refractory peripheral T-cell lymphoma: results of the pivotal phase II BELIEF (CLN-19) Study. J Clin Oncol. 2015. [Epub ahead of print]. doi: 10.1200/JCO.2014.59.2782.

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