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Idelalisib Improves PFS

Gilead Muscles Way into CLL; Halts Trial Early for Efficacy

By Marie Powers
Staff Writer

Friday, October 11, 2013
Based on the recommendation of an independent data monitoring committee (DMC), Gilead Sciences Inc. put an early stop to its Phase III study (Study 116) evaluating idelalisib in previously treated chronic lymphocytic leukemia (CLL) patients who are not candidates for chemotherapy, after a predefined interim analysis showed “highly statistically significant efficacy” for the primary endpoint of progression-free survival (PFS) in patients receiving idelalisib plus Rituxan (rituximab, Biogen Idec Inc. and Roche AG) compared to a control arm of placebo plus rituximab.

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