Tokai Halts Phase 3 Trial of Prostate Cancer Drug Galeterone; Panel Says It’s Unlikely to Reach Primary Endpoint

Tokai Halts Phase 3 Trial of Prostate Cancer Drug Galeterone; Panel Says It’s Unlikely to Reach Primary Endpoint
Tokai Pharmaceuticals (Tokai) dropped a bombshell Tuesday when it announced it will discontinue its flagship ARMOR3-SV clinical trial, a pivotal Phase 3 study comparing the efficacy of Tokai's prostate cancer drug galeterone to Astella Pharma's product Xtandi (enzalutamide). Tokai said in a press release that the decision to terminate the trial was made after the trial's independent Data Monitoring Committee (DMC) determined the ARMOR3-SV trial would likely not meet its primary endpoint of demonstrating an improvement in patient survival with galeterone compared to Xtandi in this type of cancer, which has an aggressive disease course and represents a significant unmet medical need. The drugs are designed to treat metastatic prostate cancer in patients whose prostate tumor cells express the AR-V7 splice variant, a truncated form of the androgen receptor that has been associated with non-responsiveness to commonly-used oral therapies for treatment-naïve metastatic castration-resistant prostate cancer (mCRPC), and who no longer respond to testosterone-lowering medical or surgical treatment. Galeterone is described as an orally administered small molecule that piggybacks onto the mechanistic pathways of current second-generation hormonal prostate cancer therapies, including Zytiga (abiraterone) and Xtandi (enzalutamide), while introducing a unique third mechanism -- androgen receptor degradation -- that impairs
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