The study conducted by the US National Cancer Institute is a seven-arm, Phase II, open-label trial of romidepsin in patients with cutaneous T-cell lymphoma (CTCL) and peripheral T-cell lymphoma (PTCL). The study enrolled 71 CTCL patients in three arms of the study that received romidepsin. Patients received 14mg/m2 of romidepsin infused on days one, eight and 15 every 28 days.
The primary endpoints of the trial were objective disease response rate (ORR), complete response rate (CR) and duration of response in patients who had failed previous therapy. The ORR was 39.7% (25/63 evaluable patients), 33.3% (21/63) of patients experienced a partial response (PR) and 6.3% (4/63) experienced a complete response.
The median duration of response was 11.1 months in patients experiencing PR or CR. Responses were observed at all stages of disease, including an ORR of 29.4% (10/34) in patients with stage IV disease.
Jean Nichols, president and COO of Gloucester, said: “We are also very encouraged that these data are consistent with and support the previously reported positive data from Gloucester’s registration trial of romidepsin in patients with cutaneous T-cell lymphoma.”