Gilead to stop Ph III Study 116 of idelalisib early on DMC recommendation

Following a recommendation by an independent Data Monitoring Committee (DMC), US HIV/AIDS drug major Gilead Sciences (Nasdaq: GILD) says its Phase III study (Study 116) evaluating idelalisib (formerly GS-1101) in previously-treated chronic lymphocytic leukemia (CLL) patients who are not fit for chemotherapy will be stopped early.

This DMC recommendation is based on a pre-defined interim analysis showing highly statistically-significant efficacy for the primary endpoint of progression-free survival in patients receiving idelalisib plus rituximab compared to those given rituximab alone. The safety profile of idelalisib was acceptable and consistent with prior experience in combination with rituximab in previously treated CLL. Gilead has informed the US Food and Drug Administration of the plan to end the study and will engage in a dialogue with the FDA regarding a regulatory filing in CLL. Data from Study 116 will be submitted for presentation at an upcoming scientific conference.

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