The objective of the Folotyn Phase 2b study (PDX-012) was to estimate the efficacy of Folotyn relative to that of erlotinib as assessed by OS, the primary endpoint of the trial, while the secondary endpoints included progression-free survival (PFS) and objective response rate (RR).
Reportedly, in the Folotyn Phase 2b study, patients receiving Folotyn had a 16% reduction in the risk of death compared to erlotinib in the overall (intent-to-treat) population and a 13% reduction in the risk of death in the primary efficacy analysis population.
The University of Kansas Medical Center investigator of the study Karen Kelly said that overall survival remains the most clinically relevant endpoint in assessing the benefit of an investigational therapy to treat cancer.
"I believe the survival data from this randomised Phase 2b study are compelling and warrant exploring Phase 3 options in order to fully understand the potential role of Folotyn to treat patients with advanced non-small cell lung cancer," Kelly said.
Allos Therapeutics chief medical officer Charles Morris said that the study is providing Allos and the lung cancer community with data regarding the efficacy and safety profile for Folotyn in advanced NSCLC.
"We believe these data demonstrate the clinical activity of Folotyn in patients with advanced NSCLC, and we are in the process of exploring Phase 3 development options for Folotyn in this indication," Morris said.