Allos reports positive interim data from Phase I lymphoma trial

Data were presented on 17 patients, including 14 evaluable patients who completed at least one cycle of treatment with PDX at doses ranging from 15-30mg/m2 as part of a weekly schedule for two or three weeks followed by one week of rest. Patients received a median of three prior systemic therapies.

In this Phase I open-label multi-center study, patients with either relapsed or refractory cutaneous T-cell lymphoma (CTCL) receive PDX as part of a weekly schedule for two or three weeks followed by one week of rest. In the first cohort, patients received starting doses of PDX at 30mg/m2, with dose reduction in subsequent cohorts based on toxicity.

Up to 56 evaluable patients will be enrolled in the study with the objective of determining the optimal dose and schedule for PDX in this patient population. A total of 20 of these patients will be enrolled at what is determined to be the optimal dose and schedule.

In this Phase I dose optimization study, investigator-assessed responses were observed in seven of 14 evaluable patients (50%), including two complete responses and five partial responses. Responses were observed in all four treatment cohorts.

Pablo Cagnoni, chief medical officer of Allos, said: “We are encouraged by these data, in which PDX has shown activity at a range of doses in patients with relapsed or refractory CTCL. The study will continue with the objective of determining the optimal dose and schedule for PDX in this patient population.”