Zydelig (idelalisib) + Arzerra (ofatumumab)success in study 119 for CLL and filing of sNDA at FDA- Gilead Sciences

Gilead Sciences has announced results from the Phase III clinical Study 119 of an investigational use of Zydelig (idelalisib) in combination with Arzerra (ofatumumab) in previously-treated patients with chronic lymphocytic leukaemia (CLL).In Study 119, there was a 73% reduction in the risk of disease progression or death in patients receiving idelalisib in combination with ofatumumab compared to ofatumumab alone. Detailed results were presented during a poster session at the 51st Annual Meeting of the American Society of Clinical Oncology (ASCO) (Abstract #7023).

Idelalisib regimen significantly improved progression free survival in patients with CLL. Study 119 was a randomised, controlled, open-label Phase III study evaluating the efficacy and safety of idelalisib in combination with ofatumumab. The study enrolled 261 adult patients with previously treated CLL whose disease had progressed less than 24 months following completion of prior therapy, and had not previously been refractory to ofatumumab. The primary endpoint for Study 119 was progression-free survival (PFS), defined as the time from randomisation to definitive disease progression or death assessed by an independent review committee. Median PFS in the idelalisib/ofatumumab arm was 16.3 months, compared to 8.0 months in the ofatumumab monotherapy arm.Statistically significant improvements were also observed for overall response rate and lymph node response rate.Median PFS in the approximately 40% of patients with 17p deletion or TP53 mutation was 13.7 months vs. 5.8 months. A statistically significant difference was not achieved in median overall survival (20.9 months vs. 19.4 months). The safety profile of idelalisib was similar to prior studies in previously-treated patients with CLL.

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