Phase III trial (Study 115) of Zydelig (idelalisib) is unblinded early and shows benefit in CLL- Gilead

Following the recommendation by an independent Data Monitoring Committee (DMC), Gilead Sciences, Inc. announced that its Phase III Study 115 evaluating Zydelig (idelalisib) added to standard therapy in previously-treated chronic lymphocytic leukemia (CLL) patients will be unblinded early. The DMC recommendation is based upon a predefined interim analysis indicating a statistically significant benefit in efficacy for progression-free survival (PFS) and overall survival (OS) in patients receiving Zydelig plus bendamustine and rituximab, compared to those receiving only bendamustine and rituximab

The safety profile of Zydelig was consistent with prior studies. Detailed results from this study will be presented during a late-breaking abstracts session (#LBA-5) at the Annual Meeting of the American Society of Hematology (ASH) in Orlando, Florida taking place December 5-8.