Entinostat: Phase II data
The double-blind, U.S. Phase II ENCORE 401 trial in 132 evaluable patients showed that entinostat plus Tarceva erlotinib missed the primary endpoint of significantly improving the 4-month PFS rate vs. placebo plus Tarceva (20.8% vs. 24%, p=0.505). Entinostat plus Tarceva also missed the secondary endpoints of significantly improving median PFS (1.97 vs. 1.88 months, p=0.98) and OS (8.9 vs. 6.7 months, p=0.65) vs. placebo plus Tarceva. In a subgroup of patients with elevated expression of E-cadherin ( CDH1; CD324) (n=26), a molecular marker of epithelial tumors, the combination significantly improved median OS vs. placebo (9.4 vs. 5.4 months, p=0.03), and non-significantly improved median PFS (3.7 vs. 1.9 months, p=0.19). Syndax said entinostat plus Tarceva was tolerable with no unexpected adverse events. Data were presented at American Society for Radiation Oncology meeting in Chicago. ...