Belinostat (Beleodaq)

A novel pan-HDAC inhibitor for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL).

Phase II BELIEF trial, belinostat elicited an overall response rate (ORR) of 26% in patients with relapsed or refractory PTCL following progression on at least one prior therapy.

Associated with low incidence of myelosuppression.

In the single-arm BELIEF trial, 129 patients with platelets ≥ 50,000/µL and had received a median of 2 prior therapies and were evaluated with belinostat intravenously at 1000 mg/m2 on days 1-5 of a 3-week cycle for a median of 2 cycles: the overall response rate was 26% (CR = 10%; PR = 16%), while among patients with baseline platelets ≥100,000/μL, the Overall response rate was 28% (CR = 11%; PR = 17%).

In the above study the median time to response was 5.6 weeks, the median duration of response was 8.3 months, and the longest duration of response in the trial was 29.4 months.

Side effects include: nausea, fatigue, fever, low red blood cells, and vomiting.

The most common grade 3/4 adverse events are thrombocytopenia, neutropenia, anemia, dyspnea, pneumonia, and fatigue.

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