Zydelig idelalisib: Additional Phase III data

Additional data from the double-blind, placebo-controlled, U.S. Phase III Study 115 in 416 previously treated patients with relapsed CLL showed that twice-daily 150 mg oral Zydelig plus Treanda bendamustine and Rituxan rituximab led to a 45% improvement in OS, a secondary endpoint, vs. Treanda and Rituxan alone (HR=0.55, 95% CI: 0.36, 0.86, p=0.008). Median OS has not been reached in either arm. Zydelig plus Treanda and Rituxan led to an ORR of 68% vs. 45% for Treanda and Rituxan alone. In patients with a tumor protein p53 ( TP53; p53) mutation or the chromosome 17p deletion, Zydelig plus Treanda and Rituxan led to a 50% reduction in the risk of disease progression or death vs. Treanda and Rituxan alone (HR=0.5, 95% CI: 0.32, 0.77). Data were presented at the American Society of Hematology meeting in Orlando. Gilead previously reported that Zydelig plus Treanda and Rituxan led to a median PFS, the primary endpoint, of 23.1 months vs. 11.1 months for Treanda and Rituxan alone (HR=0.33, 95% CI: 0.24, 0.45, p<0.0001) (see BioCentury, Nov. 23). ...