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.
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.
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