Gilead to early unblind Phase 3 study of Zydelig for chronic lymphocytic leukemia

Gilead Sciences, Inc. said Monday that its Phase 3 Study 115 evaluating Zydelig (idelalisib) added to standard therapy in previously-treated chronic lymphocytic leukemia (CLL) patients will be unblinded early.

Norbert W. Bischofberger, Gilead’s Executive Vice President, Research and Development and Chief Scientific Officer

According to Gilead, the independent Data Monitoring Committee (DMC) recommendation, which preceded the announcement, is based upon a predefined interim analysis indicating 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, Gilead says.

The company announced that detailed results from the study will be presented during a late-breaking abstracts session at the Annual Meeting of the American Society of Hematology (ASH) in Orlando, Florida taking place December 5-8.

Zydelig is approved in the United States in combination with rituximab for patients with relapsed CLL for whom rituximab alone would be considered appropriate therapy due to comorbidities, Gilead noted.

Norbert W. Bischofberger, PhD, Gilead’s Executive Vice President, Research and Development and Chief Scientific Officer, said:

“The clinical benefit observed in this Phase 3 study adds to the body of evidence demonstrating the potential of Zydelig-containing treatment regimens for patients with previously treated CLL. We look forward to sharing the detailed scientific data with the hematology community at the upcoming ASH meeting.”