The data showed that 29% (n=19) of the first 65 evaluable patients enrolled in the trial experienced either a complete or partial response, as assessed by central independent oncology review. Forty-five percent (n=29) of the first 65 evaluable patients experienced either a complete or partial response, as assessed by the Propel investigators. Patients are considered evaluable if they received at least one dose of PDX and their diagnosis of PTCL has been confirmed by independent review.
The median duration of response for these patients cannot be estimated at this time due to the current length of follow up. The most common drug related grade 3/4 adverse events were mucositis and thrombocytopenia, which were observed in 14% and 23% of patients, respectively. Patients received a median of three prior treatment regimens.
The company completed patient enrollment in the Propel trial in April 2008 and expects to report top line results of the trial by the end of 2008. Following its review of the trial results, the company intends to submit a new drug application for PDX as a treatment for patients with relapsed or refractory PTCL as expeditiously as possible.
Pablo Cagnoni, chief medical officer of Allos, said: “We believe PDX, a unique antifolate rationally designed for improved cancer cell uptake and retention has the potential to offer a new treatment option for patients with this challenging disease.”