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Veru Announces Positive Phase 2 Clinical Data: Efficacy of Enobosarm Therapy Correlates with Androgen Receptor Levels in AR+ER+HER2- Metastatic Breast Cancer Presented at the 2021 ASCO Annual Meeting
-- In Phase 2 study, enobosarm, an oral selective androgen receptor (AR) agonist, had the most significant antitumor effects in heavily pretreated AR+ER+
About this update from Veru Inc.
[{"type":"text","content":"-- In Phase 2 study, enobosarm, an oral selective androgen receptor (AR) agonist, had the most significant antitumor effects in heavily pretreated AR+ER+ metastatic breast cancer subjects with ≥ 40% AR expression in cancer tissue -- -- Companion diagnostic test to measure AR may be used to select AR+ER+HER2- metastatic breast cancer subjects most likely to benefit from enobosarm treatment-- -- Phase 3 ARTEST study to evaluate enobosarm treatment in subjects with ≥ 40% AR expression and estrogen blocking agent and CDK4/6 agent resistant AR+ER+HER2- metastatic breast cancer expected to commence Q3 2021 -- MIAMI, June 07, 2021 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), an oncology biopharmaceutical company with a focus on developing novel medicines for the management of prostate and breast cancer, today announced additional clinical results from the Phase 2 study demonstrating that the anticancer benefits of enobosarm, a selective androgen receptor (AR) targeting agent, were related to the presence and amount of AR expression in breast cancer tissue in subjects with AR+ER+ HER2- metastatic breast cancer, will be presented at the American Society of Clinical Oncology (ASCO) 2021 Annual Meeting being held June 4-8, 2021. Highlights of presentation: In preclinical studies, AR has been established as a tumor suppressor in breast cancer. Clinically, AR is expressed in up to 90% of breast cancers and targeting AR with enobosarm, an oral selective AR agonist, would be a major new endocrine therapy for metastatic breast cancer. The positive G200802 Phase 2 clinical study in 136 heavily pretreated women with AR+ER+HER2- metastatic breast cancer who progressed following CDK4/6 inhibitor and/or estrogen blocking agent treatment confirmed that the AR is commonly expressed in breast cancer tissue (86.5-94%) and when activated by enobosarm is acting in these patients as a tumor suppressor. In the overall Phase 2 study, the presence and the amount of AR receptor expression in breast cancer tissue correlated with a beneficial antitumor response. The best overall target lesion reduction of >30% occurred only in subjects who were AR+. In a post-hoc analysis of 84 women who had AR+ER+HER2- metastatic breast cancer, measurable disease, and centrally confirmed AR status at study entry, an AR positivity threshold of ≥ 40% in breast cancer tissue dist...