Allos Therapeutics (Allos) has provided updated data from its ongoing dose finding phase 1 study of Folotyn (pralatrexate injection) in patients with relapsed or refractory cutaneous T-cell lymphoma (CTCL). These data were showcased during a presentation at the 51st Annual Meeting of the American Society of Hematology (ASH) in New Orleans, LA.
The company has presented data on 31 patients with relapsed or refractory CTCL who have received a median of four prior systemic therapies. The dosing regimen of 15mg/m2 weekly for three weeks out of a four-week cycle was determined to be the optimal starting dose and schedule that provided activity with tolerability.
In the dose de-escalating study, 18 patients who received Folotyn at the optimal dose or higher, responses were observed in 61%. In the overall study, which included doses lower than the optimal dose, responses were observed in 39% of patients, including two complete responses and nine partial responses in patients who received Folotyn. An expansion cohort at the optimal dose of 15mg/m2 weekly for three out of a four week cycle is actively enrolling.
Steven Horwitz, chairman of the study, said: “We really need new therapies for our patients with relapsed or refractory CTCL. We are encouraged by the responses we’ve seen so far. Many of these patients have had excellent responses, even at relatively low doses of pralatrexate.”