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Veru Inc (NASDAQ: VERU) has announced additional clinical results from the Phase 2 study evaluating enobosarm, a selective androgen receptor (AR) targeting agent, in heavily pre-treated breast cancer patients.
Data will be presented at the American Society of Clinical Oncology 2021 Annual Meeting.
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 over 30% occurred only in subjects who were AR+.
In a posthoc analysis of 84 women with AR+ER+HER2- metastatic breast cancer, measurable disease, and centrally confirmed AR status responded to enobosarm in both dose arms (9 and 18 mg).
Focusing on the 9mg cohort, the dose selected for the Phase 3 ARTEST study, the best objective tumor response rate (complete + partial responses) was 48% for over 40% AR positivity versus 0% for below 40% AR positivity.
Similarly, the clinical benefit rate was 79% for over 40% AR positivity versus 18% for below 40% AR positivity.
The median radiographic progression-free survival was 5.5 months for over 40% AR positivity versus 2.75 months for below 40% AR positivity.
Enobosarm was very well tolerated without masculinizing side effects, increases in hematocrit, or liver toxicity.
The company is also advancing enobosarm into a Phase 2 clinical study, in the 2nd line metastatic setting, to evaluate the combination of enobosarm and abemaciclib in AR+ER+HER2- metastatic breast cancer patients.
The study will start in Q3 of 2021.
Price Action: VERU shares are up 3.55% at $9.04 during the market session on the last check Monday.
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