Phase III trial of Epidaza meets primary endpoint in breast cancer.- Shenzhen Chipscreen Biosciences.

Shenzhen Chipscreen Biosciences has announced that Epidaza (chidamide), an oral subtype-selective histone deacetylase (HDAC) inhibitor previously approved for recurrent and refractory peripheral T cell lymphoma in China, in combination with exemestane, reached primary endpoint (progression-free survival) in a pivotal phase III clinical trial. This trial is a randomized, double-blind, placebo controlled study involved postmenopausal patients with hormone receptor (HR)-positive, HER2-negative advanced breast cancer (ABC) failed to tamoxifen and/or nonsteroidal aromatase inhibitor.

This current clinical study is the first HDAC inhibitor combined with exemestane in a pivotal trial to demonstrate progression-free survival benefit and manageable adverse effect in HR�positive ABC patients progressed after prior endocrine therapy.

Comment: chidamide is a selective HDAC inhibitor with unique epigenetic mechanisms against tumor cell growth, immune escape and drug resistance. In an exploratory clinical study, it has been demonstrated the encouraging antitumor activity of chidamide in combination with exemestane in HR-positive ABC patients.