Gloucester reports positive results from Phase IIb lymphoma registration trial

GPI-04-0001 is a Phase IIb, non-randomized, open-label, single-arm international, multi-center registration study designed to evaluate the efficacy, safety and tolerability of romidepsin as a treatment for cutaneous T-cell lymphoma (CTCL).

The primary endpoint of the registration trial, objective disease response rate (ORR) in patients who had failed previous therapy, was achieved with an ORR of 40.3% (29/72 of evaluable patients). Approximately 33.3% (24/72) of patients experienced a partial response (PR) and 6.9% (5/72) of patients achieved a complete response (CR).

The ORR in patients with advanced stage disease (IIB-IVA) was 47.9% (23/48). Approximately 37.5% (18/48) experienced a PR and 10.4% (5/48) experienced a CR. Additionally, 92.3% (48/52) of patients with pruritus (intense itching) at the outset of the trial had some relief from their pruritus.

Secondary endpoints, including duration of response, time to response and time to progression, continue to mature and will be announced later, the company said.

Jean Nichols, president and COO of Gloucester, said: “These data will be central to Gloucester’s new drug application for romidepsin in CTCL and we continue to be pleased with the results as they mature.”