Celgene Presents Revlimid Data From Interim Analysis of Phase III SPA Trials

Celgene has announced initial clinical results from its pivotal Phase III special protocol assessment (SPA) trials using Revlimid (lenalidomide) as a new approach in the treatment of heavily pretreated patients with relapsed or refractory multiple myeloma.

The studies reported that an overwhelming statistically significant difference in time-to-progression (TTP) rate -- the primary endpoint of the two trials -- had not yet been reached for the combination therapy arms.

At the time of the interim analysis, the median TTP for the U.S. trial (MM-009) was at least 15 months and for the international trial (MM-010) more than 11 months. This is in contrast to the TTP for the dexamethasone only treated arms of both trials in which the median TTP was five months.