We are developing entinostat for use in advanced hormone receptor positive, or HR+, breast cancer. Following positive results from our Phase 2b clinical trial, ENCORE 301, entinostat in combination with Aromasin® (exemestane tablets) was granted breakthrough therapy designation by the U.S. Food and Drug Administration in advanced HR+ breast cancer.
Entinostat is currently being evaluated in a Phase 3 clinical trial in advanced HR+ breast cancer for which we are providing financial and operational support. Eastern Cooperative Oncology Group-American College of Radiology Imaging Network Cancer Research Group, or ECOG-ACRIN, is conducting this clinical trial under sponsorship and funding support from the National Cancer Institute. The Phase 3 clinical trial is designed to determine whether the addition of entinostat to Aromasin improves progression-free survival, overall survival, or both in patients with advanced HR+ breast cancer who have previously progressed after treatment with standard-of-care hormonal agents. We believe that the submission of the results of the Phase 3 clinical trial, if successful, would be sufficient for regulatory approval of entinostat in the United States.