Allos Therapeutics to present FOLOTYN trial results at ESMO Congress

Allos Therapeutics, Inc. (Nasdaq: ALTH) today announced that results from the Phase 2b investigational trial of FOLOTYN^® (pralatrexate injection) versus erlotinib in patients with Stage IIIB/IV (advanced) non-small cell lung cancer (NSCLC) will be presented at the 35^th European Society of Medical Oncology (ESMO) Congress — Milan, Italy from October 8-12, 2010.

“Randomized Phase 2b Study of Pralatrexate vs Erlotinib in Patients with Stage IIIB/IV Non-small Cell Lung Cancer (NSCLC) after Failure of Prior Platinum-Based Therapy”

"This is the first time that Allos will have an opportunity to present the results from the Phase 2b trial of FOLOTYN in patients with advanced non-small cell lung cancer," said Charles Morris, MB ChB, MRCP, chief medical officer at Allos Therapeutics. "We believe these are important results for the cancer community - generating data on the efficacy and safety profile for FOLOTYN in this treatment setting where there remains a high unmet need - and are pleased that the ESMO Congress has accepted these data as a late-breaking abstract to be highlighted in an oral presentation."

The randomized, open-label, international, multi-center Phase 2b study comparing FOLOTYN versus erlotinib, marketed as TARCEVA®, enrolled 201 current or former smokers with Stage IIIB/IV (advanced) NSCLC who had received one or two previous treatments including at least one prior platinum-based chemotherapy regimen. The objective of the trial was to estimate the efficacy of FOLOTYN compared to that of erlotinib as assessed by overall survival. The primary endpoint of the trial was overall survival. Secondary endpoints included progression-free survival and response rate, both compared to erlotinib, and the safety and tolerability of FOLOTYN.

Presentation details are as follows:

Presentation Date/Time: Monday, October 11, 13:15 - 14:30 CEST
Poster Title: "Randomized Phase 2b Study of Pralatrexate vs Erlotinib in Patients with Stage IIIB/IV Non-small Cell Lung Cancer (NSCLC) after Failure of Prior Platinum-Based Therapy"
First Author: K. Kelly, University of Kansas, Kansas City/US
Abstract Number: LBA17
Location: Chest tumors II, Gold Hall