On September 11, 2023,Veru Inc. announced clinical data from its discontinued Phase 3 ARTEST clinical trial of enobosarm monotherapy for the 3rd line or greater in the metastatic setting of AR+ER+HER2- breast cancer. As previously announced, enrollment had been discontinued in order to prioritize and to focus the clinical development of enobosarm therapy earlier in the treatment sequence, the 2nd line metastatic setting, for androgen receptor positive (AR+), estrogen receptor positive (ER+) and human epidermal growth factor receptor 2 negative (HER2-) metastatic breast cancer in the Phase 3 ENABLAR-2 (enobosarm +/- abemaciclib CDK 4/6 inhibitor) study. Data reported from the discontinued trial, which is based on an analysis of available data, may not be predictive of the results of larger, later-stage controlled clinical trials.

Product candidates that have shown promising results in early-stage clinical trials may still suffer significant setbacks in subsequent clinical trials. At the time enrollment was stopped, there were 34 evaluable patients randomized to either 9mg enobosarm monotherapy (n=16) or a standard of care active control (n=18) in the Phase 3 open label, randomized (1:1) clinical trial for the treatment of AR+ER+HER2- metastatic breast cancer with sufficient AR expression in their breast cancer tissue who had previously received at least a nonsteroidal aromatase inhibitor, fulvestrant, and a CDK4/6 inhibitor. The active control treatment group received an average of 2.6 (range 1-5) prior lines of treatment and the enobosarm 9mg monotherapy group received an average of 2.9 (range 1-5) prior lines of treatment.

On average, enobosarm or the active control was given in the 4th line treatment for AR+ER+HER2- metastatic breast cancer. Safety: Enobosarm monotherapy was generally well tolerated without masculinizing adverse events or increases in hematocrit.