Summary

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• Beleodaq (belinostat) is indicated for the treatment of adult patients with relapsed or refractory peripheral T-cell lymphoma (PTCL).
• This summary is based on the review of one systematic review(s)/meta-analysis(es). ^[1]
• The pooled Complete Response (CR) rate for untreated Peripheral T-cell Lymphoma (PTCL) patients across seven studies (502 patients) was 44% (95% CI, 39-48%).
• For relapsed/refractory (R/R) PTCL patients, the pooled CR rate across 16 studies was 14% (95% CI, 11-16%). Combination therapy based on HDAC inhibitors showed superior efficacy compared to HDAC inhibitor monotherapy in these patients (P = 0.02).
• Romidepsin monotherapy had a pooled CR rate of 17% (95% CI, 13-22%) in R/R PTCL patients, compared to belinostat and chidamide monotherapies, both with a pooled CR rate of 10% (95% CI, 5-15%).
• Thrombocytopenia was the most commonly reported hematological adverse event, while nausea was the most commonly reported non-hematological adverse event in patients treated with HDAC inhibitors.
• The studies do not provide direct comparative adverse event rates between belinostat and other HDAC inhibitors such as romidepsin or chidamide.
• There is no population types or subgroups information available in the reviewed studies.