Allos Therapeutics reports data from PROPEL trial of FOLOTYN in patients with PTCL

Jun 7 2010

Allos Therapeutics, Inc. (Nasdaq: ALTH) today reported new analyses of data from the Company's pivotal PROPEL trial of FOLOTYN^® (pralatrexate injection) in patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). These analyses demonstrated that patients who responded to FOLOTYN had up to a 44% reduction in risk of death based on independent central review of response>

“With peripheral T-cell lymphoma, there is an urgent need for treatments that help patients live longer”

"With peripheral T-cell lymphoma, there is an urgent need for treatments that help patients live longer," said Barbara Pro, M.D., associate professor in the Department of Lymphoma/Myeloma at the University of Texas M. D. Anderson Cancer Center. "The results of the PROPEL study demonstrate FOLOTYN's substantial antitumor activity in patients with relapsed or refractory PTCL, which is correlated with prolonged survival for patients with both responsive and stable disease. This is an important finding in this aggressive and difficult-to-treat lymphoma. Survival is the ultimate goal for patients and clinicians, and these data support the growing body of clinical evidence suggesting that FOLOTYN is an effective treatment option for patients with relapsed or refractory PTCL."

PROPEL Poster Presentation

Abstract #8054 Pralatrexate in Patients With Relapsed/Refractory Peripheral T-cell Lymphoma
(PTCL): Relationship Between Response and Survival

A poster presentation characterized the relationship between response to FOLOTYN and survival among patients with relapsed or refractory PTCL in the PROPEL study. The relationship between objective response and survival were analyzed using time-dependent covariate and landmark methods, which are two well accepted statistical methods for analyzing the association between tumor objective response and survival.

• 109 patients were evaluated for safety and efficacy, including 69 patients (63%) who had no evidence of response to the most recent prior therapy.
  • These patients achieved an overall response rate of 29% (32/109) based on independent central review of response, and 39% (40/109) based on investigator review of response.
  • Responses were durable with a median duration of response of 10.1 months based on independent central review.
  • Additionally, according to independent central review, 63% of all responses occurred within the first cycle (<7 weeks). The cycle 1 responses were used for the landmark analysis.
  • Median overall survival was 14.5 months with 55% of patients surviving >12 months.
  • In the time-dependent covariate analyses, patients who responded to FOLOTYN had a 44% reduction in risk of death>
  • In the landmark analyses, patients who responded to FOLOTYN had a 31% reduction in risk of death>
  • Further exploratory analysis showed that stable disease also correlated with improved survival compared to patients with progressive disease.