The results according to the Propel investigators at the time of this analysis showed that 42 of 109 evaluable patients (39%) achieved either a complete or partial response, 18 evaluable patients had a complete response or complete response unconfirmed, 24 evaluable patients had a partial response and 21 evaluable patients had stable disease as best response.
In the trial, 69% of the patients who responded did so after cycle one of therapy. The median duration of treatment in responding patients was 179 days at the time of this analysis. The duration of response exceeded three months in 17 of 29 responders (59%), including six of the 17 patients who continued on treatment. An accurate estimate of the median duration of response cannot be reported at this time due to the current length of follow up, the company said.
Patients will continue to be followed until the median duration of response can be accurately estimated. Following review of the final results of the trial, the company intends to submit a new drug application to the FDA in the first half of 2009 to seek marketing approval for pralatrexate for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL).
Pablo Cagnoni, chief medical officer of Allos, said: We are pleased to share these data with the medical community. The results show that pralatrexate, a novel targeted antifolate designed to accumulate preferentially in cancer cells, achieved durable responses, including complete responses, in patients with relapsed or refractory PTCL. We believe pralatrexate has the potential to offer a new treatment option for patients with this devastating disease for which there are currently no approved agents.