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.
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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%).