Favrille drug fails secondary goal

An interim analysis of the secondary endpoint indicated that FavId did not demonstrate a statistically significant difference between treatment and control groups in response improvement. The primary endpoint in the trial is time to disease progression.

In the phase III trial FavId was administered following Rituxan induction therapy. The interim analysis showed a high percentage of patients converted to complete remission over time. The objective response rate was first assessed eight weeks following Rituxan induction treatment, at which time it was 64%, with 18% of patients in complete remission. Data showed that 41% of patients who were assessed as stable disease or partial remission at the end of Rituxan induction treatment had a response improvement, and 80% of those patients converted from partial to complete remission.

“The most clinically important observation from this interim analysis was that nearly 50% of patients in this trial achieved complete remission over time,” said John Longenecker, president and CEO of Favrille.

“This means that we are now following a large set of patients who have converted to complete remission. Although we did not see statistical difference in overall response improvement between the two arms, indicating more late responses to the control arm than we had expected, it is important to remember that the unmet medical need in the treatment of indolent B-cell non-Hodgkin's lymphoma is the durability of a response.”

Despite the failure to achieve statistical significance in overall response rate, Favrille said that it was optimistic about the durability of responses in FavId treated patients. The company plans to file a biologics license application in the second half of 2007.