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Veru's Enobosarm Efficacy Correlates with Androgen Receptor Levels in Metastatic Breast Cancer Patients

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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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