Veru Inc. announced that the clinical results from the Phase 2 clinical study of enobosarm, an oral selective androgen receptor targeting agonist, in heavily pretreated women with AR+ER+HER2- advanced breast cancer including further efficacy data and an analysis of patients who have failed both estrogen blocking agents and CDK 4/6 inhibitors, will be presented at the European Society for Medical Oncology (ESMO) Breast Cancer Virtual Congress 2021 to be held May 05-08, 2021. The subset analysis of patients from the Phase 2 study who were heavily pretreated with estrogen blocking agents and chemotherapy with an average of 3 prior lines of therapy in the metastatic setting and had tumor progression on a CDK 4/6 inhibitor prior to receiving enobosarm. Enobosarm treatment in evaluable patients with measurable metastatic AR+ER+ breast cancer who had progressed following treatment with an estrogen blocking agent and CDK 4/6 inhibitor (palbociclib) resulted in a clinical benefit rate at 24 weeks of 50% and a best objective tumor response of 30% including 2 complete responses and 1 partial response. The overall mean radiographic progression free survival for the 9mg dose was 10 months. The 9mg dose of enobosarm was selected for the Phase 3 ARTEST study that is anticipated to commence in June 2021. Enobosarm is an oral, first-in-class, new chemical entity, selective androgen receptor targeting agonist that activates the androgen receptor, tumor suppressor, in AR+ER+HER2- metastatic breast cancer. Enobosarm is in clinical development for the treatment of metastatic ER+HER2- breast cancer patients whose disease has progressed after treatment with a nonsteroidal aromatase inhibitor (anastrozole or letrozole), fulvestrant, and a CDK4/6 inhibitor. The Phase 3 ARTEST clinical trial is expected to begin enrollment during the second quarter of 2021. The Phase 2 clinical study (G200802) was an international, open label, parallel design, randomized study to investigate the efficacy and safety of enobosarm 9mg and 18mg oral daily dosing in 136 heavily pretreated women with ER+HER2- metastatic breast cancer who had breast cancer progression being treated with multiple lines of endocrine therapy including CDK 4/6 inhibitors and 90% who had also failed chemotherapy. Patients were randomized to receive enobosarm 9mg (n=72) or 18mg (n=64) oral daily dosing. The primary endpoint was clinical benefit rate at 24 weeks (defined as CR+PR+SD) by RECIST 1.1. Secondary endpoints included objective response rate, best overall response rate, radiographic progression-free survival (rPFS), and duration of clinical benefit.