Gilead: Zydelig With Ofatumumab Improves PFS In Lymphocytic Leukemia

(RTTNews) - Gilead Sciences Inc. (GILD) announced results from the Phase 3 clinical Study 119 of an investigational use of Zydelig (idelalisib) in combination with ofatumumab in previously-treated patients with chronic lymphocytic leukemia. In Study 119, there was a 73 percent reduction in the risk of disease progression or death in patients receiving Zydelig in combination with ofatumumab compared to ofatumumab alone. The safety profile of Zydelig was similar to prior studies.

Study 119 enrolled 261 adult patients with previously treated chronic lymphocytic leukemia whose disease had progressed less than 24 months following completion of prior therapy, and had not previously been refractory to ofatumumab.

Based on the Study 119 trial results, Gilead has filed a supplemental New Drug Application (sNDA) with the U.S. FDA to include data from this study in the U.S. label. Gilead plans to submit a supplemental filing to the European Medicines Agency later in the current year.