Allos Therapeutics (ALTH) Updates on FOLOTYN PROPEL

Allos Therapeutics, Inc. (Nasdaq: ALTH), updates on data from a retrospective analysis of data from the Company’s pivotal PROPEL trial, which assessed the safety and efficacy of single-agent FOLOTYN® (pralatrexate injection) as a second-line treatment in patients with relapsed or refractory peripheral T-cell lymphoma (PTCL) who received CHOP as their first-line treatment.

From the release:

PROPEL enrolled 115 patients, 109 of whom were considered evaluable for efficacy according to the trial protocol. Study endpoints included overall response rate – defined as complete response, unconfirmed complete response, and partial response – as well as duration of response, progression-free survival, and overall survival. Of the 15 evaluable patients who received FOLOTYN as a second-line treatment post-CHOP:

• Objective responses with FOLOTYN were observed in seven patients (47%) as assessed by independent central review and in six patients (40%) as assessed by local investigators.
  
• Complete responses – meaning there was a complete regression of all signs of disease in response to treatment with FOLOTYN – were observed in three of the 15 patients (20%), based on independent central review, and four of the 15 patients (27%), based on local investigator review.
  • Two of these patients went on to receive a stem cell transplant after responding to FOLOTYN and sustained complete responses for 20.9 and 27.2 months through the time of last contact.
• Median duration of response, by independent central review, had not yet been reached at the time of analysis; by local investigator review, the median duration of response was 12.5 months.
  
• Progression-free survival was 8.1 months by independent central review and 7.4 months per local investigator review.
  
• Median overall survival was not able to be estimated as 11 (75%) of the 15 patients were still alive at the time of last contact; the 12-month overall survival estimate was 73 percent.

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