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Gilead Sciences' Phase III Study evaluating Zydelig (idelalisib) added to standard therapy in previously-treated chronic lymphocytic leukemia (CLL) will be unblinded early following the recommendation by an independent Data Monitoring Committee (DMC) based on a interim analysis indicating a statistically significant benefit in efficacy for progression-free survival (PFS) and overall survival (OS).

Gilead Sciences' Phase III Study evaluating Zydelig (idelalisib) added to standard therapy in previously-treated chronic lymphocytic leukemia (CLL) will be unblinded early following the recommendation by an independent Data Monitoring Committee (DMC) based on a interim analysis indicating a statistically significant benefit in efficacy for progression-free survival (PFS) and overall survival (OS).

The Phase III study is evaluating the efficacy and safety of Zydelig in combination with bendamustine and rituximab in 416 adult patients with previously treated CLL. Eligible patients were randomized (1:1) to receive six cycles of bendamustine and rituximab over 24 weeks combined with either Zydelig 150 mg or placebo taken orally twice daily continuously until disease progression or unacceptable toxicity. The primary endpoint is PFS.

Zydelig is approved in the U.S. in combination with rituximab for patients with relapsed CLL for whom rituximab alone would be considered appropriate therapy. The use of Zydelig in combination with bendamustine/rituximab is investigational.

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Title Annotation:Phase III
Publication:Contract Pharma
Date:Jan 1, 2016
Words:155
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