US-China biotech firm EOC Pharma has received market approval from China’s National Medical Products Administration (NMPA) for its entinostat, an oral histone deacetylase (HDAC) inhibitor, for the treatment of locally advanced or metastatic breast cancer in patients with hormone receptor (HR) positive and human epidermal growth factor receptor-2 (HER2) negative status after endocrine therapy combined with an aromatase inhibitor.
A pivotal Phase III clinical trial, which was randomized, double-blinded, and placebo-controlled, evaluated the drug’s combination with exemestane as a treatment for HR+, HER2- advanced breast cancer and met its pre-set primary endpoint. The study demonstrated that the entinostat and exemestane combination significantly improved progression-free survival (PFS) in patients with advanced breast cancer who had previously failed endocrine therapy, with a PFS hazard ratio (HR) of 0.76. There was also a trend indicating a benefit in overall survival (OS) with a HR of 0.837, while the safety profile of the combination was favorable.- Flcube.com
