Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Allos Therapeutics, a Colorado-based biopharmaceutical company, has noticed a consistent, high response rates and tolerability at the optimal dose during the Phase 1 study of Folotyn (pralatrexate injection) in patients with relapsed or refractory cutaneous T-cell lymphoma (CTCL), a group of often slow-growing non-Hodgkins lymphomas that primarily manifest in the skin.
Subscribe to our email newsletter
The data was presented during a presentation at the European Hematology Association (EHA) meeting being held June 10-13, 2010 in Barcelona, Spain.
According to Allos, out of 54 patients enrolled in this dose de-escalation study, data were available for 48 patients with relapsed or refractory CTCL who received a median of 4 prior systemic therapies.
The findings of the study revealed that Folotyn administered at 15 mg/m2 via IV push 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.
Of the 29 patients who received Folotyn at the optimal dose, 22 were evaluable for efficacy and 23 were evaluable for safety. The response rate for patients treated at the optimal dose was 45% (10/22).
Of the patients who received Folotyn at the optimal dose or higher, 53% (18/34) achieved a response, including one complete response and 17 partial responses.
In a subgroup analysis, responses to Folotyn were observed in patients who had failed key prior systemic therapies, including 42% (10/24) of patients who failed prior oral bexarotene, 40% (4/10) of methotrexate failures, 35% (7/20) of patients who failed HDAC inhibitors, and 24% (4/17) of interferon failures.
The biopharmaceutical has added that the Folotyn was well tolerated at the optimal dose, with 48% (11/23) of patients experiencing at least one adverse event. The only grade 3 adverse event observed was mucositis in 17% (4/23) of patients. No grade 4 adverse events were observed at the optimal dose. The most common adverse events, any grade, were mucositis (39% grade 1-3), nausea (22% grade 1-2) and fatigue (17% grade 1-2).
Charles Morris, chief medical officer at Allos Therapeutics, said: “CTCL is often an indolent disease, thus the goal of this trial was to identify an optimal dose with good activity and acceptable toxicity to allow continuous or maintenance treatment.
“We are encouraged by the consistent, high response rates and tolerability achieved at the optimal dose in this heavily pre-treated relapsed or refractory CTCL patient population. We look forward to completing patient follow up in this study and to further clinical evaluation of Folotyn as a potential treatment option for patients with CTCL.”