Allos Therapeutics reports new analysis of PROPEL trial data of FOLOTYN in patients with refractory PTCL

Dec 6 2010

Allos Therapeutics, Inc. (NASDAQ:ALTH) today reported new analysis of data from the Company's pivotal PROPEL trial of FOLOTYN^® (pralatrexate injection) in patients with relapsed or refractory peripheral T-cell lymphoma (PTCL) at the 52^nd American Society of Hematology (ASH) Annual Meeting in Orlando, Florida. The objective of this retrospective subgroup analysis was to assess the activity and safety of single-agent FOLOTYN in patients enrolled in PROPEL who were diagnosed with histologically confirmed relapsed or refractory transformed mycosis fungoides (tMF), which is an aggressive and difficult to treat T-cell lymphoma.

“This analysis of the data from PROPEL provides important information about the clinical activity of FOLOTYN in patients with relapsed or refractory transformed mycosis fungoides. Results of this subgroup analysis demonstrated the activity and safety of single-agent FOLOTYN and its utility in patients with relapsed or refractory transformed mycosis fungoides”

"The activity observed in this analysis is extremely encouraging for patients with relapsed or refractory transformed mycosis fungoides, which is a difficult to treat and an aggressive form of T-cell lymphoma often associated with poor prognosis," said Francine Foss, M.D., professor of medicine (hematology) and of dermatology, Yale School of Medicine.

This analysis was based on assessment using International Workshop Criteria (IWC) by an independent central review as well as local investigator review. Of the 12 patients included in this analysis, objective responses were observed in three patients (25%) based on independent central review and in seven patients (58%) based on local investigator review. The median duration of response was 2.2 months based on independent central review and 4.4 months based on local investigator review. Prior to enrollment, patients with tMF received a median of 3 systemic therapies - eight patients (67%) had received prior treatment with a CHOP-based regimen (cyclophosphamide/doxorubicin/vincristine/prednisone).

The most common Grade 3-4 adverse events were mucositis (8%), fatigue (8%), and nausea (8%). The most common Grade 2 adverse events were mucositis (33%), fatigue (17%), nausea (8%), and pyrexia (8%). No patients discontinued therapy due to an adverse event.

"This analysis of the data from PROPEL provides important information about the clinical activity of FOLOTYN in patients with relapsed or refractory transformed mycosis fungoides. Results of this subgroup analysis demonstrated the activity and safety of single-agent FOLOTYN and its utility in patients with relapsed or refractory transformed mycosis fungoides," said Charles Morris, MB ChB, MRCP, chief medical officer at Allos Therapeutics.

FOLOTYN is the first and only drug approved by the FDA for the treatment of patients with relapsed or refractory PTCL. This indication is based on overall response rate. Clinical benefit such as improvement in progression free survival or overall survival has not been demonstrated.