Allos Therapeutics has announced positive top-line results for a Phase IIb trial of Folotyn (pralatrexate injection) in patients with advanced non-small cell lung cancer.

The objective of the study was to estimate the efficacy of Folotyn compared to erlotinib, an approved active agent in non-small cell lung cancer, as assessed by overall survival.

It also evaluated the progression-free survival and response rate, both compared to erlotinib, and the safety and tolerability of the pralatrexate injection.

Patients receiving Folotyn showed a 16% reduction in the risk of death compared in the overall patient population and a 13% reduction in the primary efficacy analysis population.

The largest reductions in risk of death for Folotyn were observed in patients with non-squamous cell carcinoma and light smokers.

The most common adverse event observed in patients treated with the drug was mucositis, followed by thrombocytopenia, nausea and fatigue.

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The study enrolled 201 current or former smokers with advanced non-small cell lung cancer who had received one or two previous treatments, including at least one prior platinum-based chemotherapy regimen.