Istodax Active against Refractory Cutaneous T-cell Lymphoma

Final results from a Phase II clinical trial provide additional evidence that Istodax® (romidepsin) is active against refractory cutaneous T-cell lymphoma. These results were published in the Journal of Clinical Oncology.

Cutaneous T-cell lymphoma (CTCL) is a rare type of non-Hodgkin’s lymphoma that begins in the skin. The most common type of CTCL is mycosis fungoides.

Istodax—a histone deacetylase (HDAC) inhibitor—works by slowing the growth of cancer cells. It was approved in 2009 for the treatment of CTCL in patients who had received at least one prior systemic therapy.

The current report provides final results from one of the studies that contributed to the approval of Istodax. The study enrolled 96 patients with Stage IB to IVA CTCL who had received at least one prior systemic therapy. All patients were treated with Istodax on days 1, 8, and 15 of each 28-day cycle.

34% of patients had a response to treatment (reduction or elimination of detectable lymphoma). Six patients had a complete response (no detectable lymphoma).
Among patients with advanced disease, 38% had a response to treatment. Five patients had a complete response.
The median time to response was two months, and the median duration of response was 15 months.
43% of patients experienced an reduction in itching.
Side effects tended to be mild, and most commonly involved gastrointestinal disturbances and weakness or lack of energy.

These results provide additional evidence that Istodax is active against refractory CTCL, and generally well tolerated by patients.

Reference: Whittaker SJ, Demierre M-F, Kim EJ et al. Final results from a multicenter, international, pivotal study of romidepsin in refractory cutaneous T-cell lymphoma. Journal of Clinical Oncology. Early online publication August 9, 2010.