First Breast Cancer Patient in Japanese Trial Receives Entinostat

First Breast Cancer Patient in Japanese Trial Receives Entinostat
The first patient has been dosed in a pivotal Phase 2 clinical trial in Japan evaluating entinostat as a therapy for hard-to-treat breast cancers. Syndax Pharmaceuticals, which developed the therapy, said the trial (NCT03291886) will cover patients with advanced or recurrent hormone receptor-positive (HR+) and HER2-negative (HER2-) breast cancers. A pivotal trial is one that is intended to provide evidence for a treatment's marketing approval. It is usually a Phase 2 or 3 trial. Under a 2015 licensing agreement, Kyowa Hakko Kirin has exclusive rights to develop and market entinostat in Japan and Korea. So the company is conducting the trial in Japan. Entinostat is an oral class-1 histone deacetylase inhibitor. It blocks immunosuppressive cells in tumors, including myeloid-derived suppressor cells and regulatory T-cells. Syndax conducted a Phase 2b clinical trial before the one in Japan. It showed that a combination of entinostat and Pfizer's approved hormone therapy Aromasin (exemestane) improved the overall survival of patients with HR+ breast cancer. The findings of the ENCORE 301 trial (NCT00676663) led to the U.S. Food and Drug Administration granting the drug Breakthrough Therapy status
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