Folotyn pralatrexate: Updated Phase I data

Updated data from an ongoing, open-label, dose-escalation Phase I trial showed that the response rate in 22 evaluable patients who were treated with the optimal dose of weekly 15 mg/m 2 Folotyn for 3 weeks of a 4-week cycle was 45%. In 34 patients who received Folotyn at the optimal dose or higher, the response rate was 53%, including 1 complete response and 17 partial responses.

In a subset of patients who previously failed various systemic therapies, Folotyn produced a response in 10 of 24 patients who failed oral Targretin bexarotene, 4 of 10 patients who failed methotrexate, 7 of 20 patients who failed histone deacetylase (HDAC) inhibitors, and 4 of 17 patients who failed interferon (IFN) therapy. The only >=grade 3 adverse event observed was mucositis. Allos enrolled 54 patients in the dose-escalation portion of the trial, with an additional 29 patients enrolled in an expanded optimal dose cohort. Data were presented at the European Hematology Association meeting in Barcelona. ...