Gloucester’s cancer drug found effective against lymphoma

Of the 73 evaluable cutaneous T-cell lymphoma (CTCL) patients, an overall response rate of 37% (27/73) was reported, with four complete responses (6%), 23 partial responses (31%) and 40 patients with stable disease (55%). Six patients had progressive disease. Significant pruritus relief was observed in 37% of patients who had severe pruritus at baseline. Additionally, 38% of the patients who exhibited any pruritus at baseline reported significant relief from symptoms.

GPI-04-0001 is a Phase II, non-randomized, open-label, single-arm international, multi-center study designed to evaluate the efficacy, safety and tolerability of romidepsin as a treatment for CTCL. Study patients receive romidepsin at a dose of 14 mg/m2 intravenously over 4 hours on days 1, 8 and 15 of each 28-day cycle. The duration of study treatment is 6 cycles although patients who show an objective response or stable disease may continue to receive therapy, at the discretion of the investigator and patient, until disease progression or another withdrawal criterion is met.

William McCulloch, executive vice-president and chief medical officer at Gloucester, said: “Romidepsin continues to demonstrate significant single-agent activity in the treatment of T-cell lymphomas as well as encouraging clinical response in combination with other cancer agents with a manageable toxicity profile.”