Allos Therapeutics announced the presentation of further data from its Phase 2b study of Folotyn (pralatrexate injection) relative to Tarceva (erlotinib, from Genentech) in patients with Stage IIIB/IV (advanced) non-small cell lung cancer (NSCLC). The objective of this randomized, international, multi-center study (PDX-012) was to estimate the efficacy of Folotyn relative to that of erlotinib as assessed by overall survival, the primary endpoint of the trial. As previously reported, patients receiving Folotyn had a 16 percent reduction in the risk of death compared to erlotinib in the overall (intent-to-treat) population (n=201; hazard ratio (HR)=0.84) and a 13 percent reduction in the risk of death in the primary efficacy analysis population (n=166; HR=0.87). Review of the predefined patient cohorts indicated that the majority of cohorts responded favorably to Folotyn relative to erlotinib. The largest benefit was observed in patients with non-squamous cell carcinoma, while comparable survival was observed across both treatments in patients with squamous cell carcinoma.

The additional data presented were based on analyses of the overall population (n=201) and showed that when adjusting for potential imbalances in several important baseline factors, the hazard ratio for overall survival, which favored Folotyn, was 0.73. The presentation also included additional data from patients with non-squamous cell carcinoma (n=107) and squamous cell carcinoma (n=76). Further details presented showed that of those patients with non-squamous cell carcinoma who received Folotyn (n=61), 25 percent (n=15) had received prior treatment with pemetrexed. Additionally, in patients with squamous cell carcinoma, a hazard ratio of 1.06 was observed for progression-free survival, which reinforces the potential activity of Folotyn, given that erlotinib has historically shown a benefit in both overall and progression-free survival relative to placebo in patients with squamous cell carcinoma.

Folotyn is a folate analogue inhibitor already indicated for the treatment of elapsed or refractory peripheral T-cell lymphoma.

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