Veru Inc. has announced the initiation of a Phase 2 clinical trial to evaluate the combination of enobosarm and abemaciclib in patients with androgen receptor-positive (AR+), estrogen receptor-positive (ER+), and HER2-negative metastatic breast cancer. This trial aims to assess the efficacy and safety of this novel combination in patients who have progressed on prior endocrine therapy and CDK4/6 inhibitors.
The study will investigate enobosarm, a selective androgen receptor modulator (SARM), in conjunction with abemaciclib, a CDK4/6 inhibitor. The rationale behind this combination lies in the potential of enobosarm to enhance the effectiveness of abemaciclib in AR+ ER+ HER2- metastatic breast cancer. The trial is designed to address the unmet medical need for patients who have exhausted standard treatment options.
Trial Design and Objectives
The Phase 2 trial is a single-arm, open-label study. Eligible patients must have AR+ ER+ HER2- metastatic breast cancer and have experienced disease progression on prior endocrine therapy and a CDK4/6 inhibitor. The primary endpoint of the trial is the objective response rate (ORR), while secondary endpoints include clinical benefit rate, progression-free survival (PFS), overall survival (OS), and safety.
Patients will receive enobosarm orally once daily in combination with abemaciclib twice daily. The study will enroll patients at multiple sites across the United States. The data from this trial will provide critical insights into the potential of AR modulation in combination with CDK4/6 inhibition in this specific breast cancer subtype.
Background on Enobosarm and Abemaciclib
Enobosarm is an oral selective androgen receptor modulator (SARM) that selectively binds to the androgen receptor in muscle and bone, promoting anabolic effects without the virilizing effects associated with traditional androgens. Abemaciclib is a CDK4/6 inhibitor that blocks cell cycle progression, leading to cell cycle arrest and apoptosis in cancer cells.
Clinical Significance
AR+ ER+ HER2- metastatic breast cancer represents a subset of breast cancers with limited treatment options after progression on initial therapies. This Phase 2 trial could provide evidence for a new therapeutic strategy to improve outcomes for these patients. The results are eagerly awaited by the medical community and patient advocacy groups.
