Gilead Cuts CLL Trial Early

Gilead Sciences’ Phase III study (Study 116) of idelalisib in previously-treated chronic lymphocytic leukemia (CLL) patients who are not fit for chemotherapy will be stopped early. The decision followed a recommendation by an independent Data Monitoring Committee (DMC) and is based on a predefined interim analysis showing highly statistically significant efficacy for the primary endpoint of progression-free survival in patients receiving idelalisib plus rituximab compared to those receiving 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 FDA 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.

Patients from Study 116 randomized to idelalisib will continue receiving idelalisib and patients in the control arm (placebo plus rituximab) will become eligible to receive open-label idelalisib therapy in an extension study. Gilead is also planning an expanded access program (EAP) for patients with recurrent CLL who are not fit for chemotherapy and require treatment.

A new drug application (NDA) for idelalisib was submitted for refractory indolent non-Hodgkin’s lymphoma (iNHL) on September 11, 2013. Gilead plans to file for regulatory approval of idelalisib in the European Union later this year.