Allos Therapeutics reports results from FOLOTYN pivotal trial against peripheral T-cell lymphoma

Allos Therapeutics, Inc. (NASDAQ: ALTH) today reported results from a retrospective analysis of data from the Company's pivotal PROPEL trial which suggested that treatment with single-agent FOLOTYN^® (pralatrexate injection) may result in increased response rates and progression-free survival relative to the immediate prior line of therapy in patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). The analysis assessed those patients enrolled in the PROPEL trial who had received two or more lines of therapy prior to enrolling in the study and receiving FOLOTYN. Data were presented at the 11^th International Conference on Malignant Lymphoma (ICML) in Lugano, Switzerland (June 15-18).

The authors described a pattern of 'progressive resistance' as a continual decrease of responses and progression-free survival in patients in the second-line treatment setting and then with each subsequent therapy - a pattern often observed in hematologic malignancies and solid tumors.

"This analysis not only provides insight into the occurrence of progressive resistance in the treatment of patients with peripheral T-cell lymphoma, but also suggests that FOLOTYN may reverse the pattern of progressive resistance observed in patients with relapsed or refractory peripheral T-cell lymphoma," said Charles Morris, MB ChB, MRCP, chief medical officer at Allos Therapeutics.

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. Patients enrolled in PROPEL had a median of three prior systemic therapies.

As previously reported, this analysis was conducted to determine whether a trend of progressive resistance is observed in patients with relapsed or refractory PTCL, as well as to identify the efficacy of FOLOTYN as a subsequent therapy compared to previous treatments in patients enrolled in the PROPEL trial - thus assessing the potential ability of FOLOTYN to overcome progressive drug resistance.

Analysis of the historical data available for patients - including prior treatments received and responses observed - showed a decrease in overall response rate and progression-free survival with each sequential treatment received prior to enrolling in PROPEL and receiving FOLOTYN:

• In patients who received three or more lines of therapy prior to enrolling in PROPEL
• In patients who received two or more lines of therapy prior to enrolling in PROPEL

Following treatment with FOLOTYN, response rates and progression-free survival increased relative to the previous line of therapy:

• In patients who received three or more prior therapies, response rates increased from 30 percent (17 of 57 patients) to 40 percent (23 of 57 patients); median progression-free survival increased from 95 days to 134 days.
• In patients who received two or more prior therapies, response rates increased from 29 percent (25 of 86 patients) to 40 percent (34 of 86 patients); median progression-free survival increased from 89.5 days to 119 days.

Analysis of the overall patient population, all of whom received one or more lines of therapy prior to enrolling in PROPEL, showed a response rate of 38 percent (41 of 109 patients) with the most recent prior therapy and 39 percent (43 of 109 patients) with FOLOTYN treatment; median progression-free survival increased from 114 days with the most recent prior therapy to 121 days with FOLOTYN treatment.

Details of safety and adverse events have been reported previously. Mucositis (Grade 3-4) was one of the most common adverse events; twenty-five patients (23%) had their dose reduced due to mucositis. Other common Grade 3-4 adverse events were thrombocytopenia, neutropenia, anemia, and dyspnea. Fifty patients (45%) experienced serious adverse events; most common serious AEs were pyrexia (7%), mucositis (5%), febrile neutropenia (5%), sepsis (5%), dehydration (4%), and dyspnea (4%).