Istodax is a member of a new class of cancer drugs known as histone deacetylase (HDAC) inhibitors. HDACs catalyse the removal of acetyl groups from acetylated lysine residues in histones, resulting in the modulation of gene expression.
In the study, patients with histopathologically confirmed PTCL who failed or were refractory to prior systemic therapy received 14mg/m2 of Istodax as a four-hour infusion on days 1, 8 and 15 of a 28-day cycle for up to six cycles.
Celgene said the treatment could be extended for response or stable disease.
The study result suggested that of 130 patients with histopathologically confirmed PTCL in the study, the overall response rate was 26% (34/130), as assessed by an Independent Review Committee (IRC) using the International Workshop Criteria.
In the trial, 13% (17/130) of patients achieved a complete response – the primary endpoint of the study – and another 13% (17/130) achieved a partial response.
The median duration of response for all patients who responded was 12 months (range 1-801+ days). The median duration of response for patients who achieved a complete response has not been reached (median duration of follow-up: 8.2 months), and 82% (14/17) of patients with a complete response had not progressed as of the data cut-off for the IRC evaluation ( 31March 2010).