Favrille Study Didn't Meet Endpoint

It claims advances in durability of response.
Author:
Publish date:

Favrille

(FVRL)

said a study of its FavId treatment for non-Hodgkins lymphoma didn't demonstrate a statistically significant difference in response improvement.

The San Diego-based biotech said the results came in a planned interim analysis of a secondary endpoint in the first 233 patients enrolled in an ongoing pivotal, placebo-controlled Phase 3 clinical trial of FavId following Rituxan induction therapy in patients with follicular B-cell non-Hodgkin's lymphoma.

"The most clinically important observation from this interim analysis was that nearly 50% of patients in this trial achieved complete remission over time," said CEO John P. Longenecker. "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 NHL is the durability of a response. This analysis shows we will have a large number of patients in both partial and complete remission to follow for our primary endpoint of time to disease progression."