Allos’ FOLOTYN Shows Activity and Tolerability in Phase 1 Dose Finding Study in Relapsed or Refractory CTCL
News Jun 14, 2010
Allos Therapeutics, Inc. has announced 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), a group of often slow-growing non-Hodgkins lymphomas that primarily manifest in the skin.
These data were presented during a poster presentation at the European Hematology Association (EHA) meeting being held June 10-13, 2010 in Barcelona, Spain.
“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”
The company announces that, of the 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. 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. FOLOTYN was well tolerated at the optimal dose, with forty-eight percent (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).
“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,” said Charles Morris, MB ChB, MRCP, chief medical officer at Allos Therapeutics, Inc. "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."