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.
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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.
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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.
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