As previously reported, 29 of 109 evaluable patients, or 27%, achieved a response as assessed by central independent oncology review, which is the primary endpoint of the trial. The Propel trial database has been locked and the Kaplan-Meier estimate for the median duration of response is 287 days, or 9.4 months. Duration of response is the key secondary endpoint of the trial.
Based on these results, the company intends to submit a new drug application to the FDA for pralatrexate for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL) in the first half of 2009.
Pralatrexate has orphan drug designation and fast track designation in the US for the treatment of patients with T-cell lymphoma and orphan medicinal product designation in Europe for the treatment of PTCL. There are currently no FDA-approved agents for patients with PTCL, either in the first-line or relapsed or refractory setting, the company said.
Pablo Cagnoni, chief medical officer of Allos Therapeutics, said: We believe pralatrexate, a novel targeted antifolate designed to accumulate preferentially in cancer cells, has the potential to provide a new treatment option for patients with this devastating disease for which there are currently no approved agents.