Breakthrough designation for Syndax's entinostat

Syndax Pharmaceuticals Inc. (Waltham, Mass.) said FDA granted breakthrough therapy designation to entinostat to treat locally recurrent or metastatic estrogen receptor-positive breast cancer when added to exemestane in postmenopausal women whose disease has progressed following non-steroidal aromatase inhibitor therapy. The designation is based on data from the Phase II ENCORE 301 trial, which showed that the oral histone deacetylase (HDAC) inhibitor plus exemestane led to an overall survival (OS) of 28.1 months vs. 19.8 months for placebo plus exemestane at a median follow-up of 25 months (p=0.04). In 1Q14, the ECOG-ACRIN Cancer Research Group plans to start a Phase III trial to treat estrogen receptor-positive breast cancer in postmenopausal women who have progressed on hormonal therapy. ...