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Dr. Shore highlights EMBARK trial data on enzalutamide in biochemically recurrent prostate cancer


"The hazard ratio was 0.42, which is a 58% reduction of an MFS event in favor of the combination arm," says Neal D. Shore, MD, FACS.

In this video, Neal D. Shore, MD, FACS, highlights study results from the phase 3 EMBARK trial (NCT02319837) in biochemically recurrent prostate cancer, which were presented at the 2023 American Urological Association Annual Meeting in Chicago, Illinois. Shore is the medical director of Carolina Urologic Research Center in Myrtle Beach, SC, and the chief medical officer for urology and surgical oncology at GenesisCare.

Video Transcript:

This was a trial of a little over 1000 patients, globally conducted. We had 3 arms. The first 2 arms were blinded. One arm was enzalutamide plus ADT, or leuprolide. The second arm was leuprolide, and a placebo. And the third arm, which was open label, was monotherapy with enzalutamide. The primary endpoint of the study was comparing the combination of enza/leuprolide to leuprolide alone with a placebo control, and it was a metastasis free survival, which is a composite endpoint of radiographic progression and/or a death. The hazard ratio was 0.42, which is a 58% reduction of an MFS event in favor of the combination arm.

So, we met our primary endpoint, which was the MFS comparing the combination versus the monotherapy LHRH [luteinizing hormone-releasing hormone]. Key secondary endpoints included the metastasis free survival for the enzalutamide monotherapy, open label arm. And that was also statistically significant, with a hazard ratio of .62. These p values were highly statistically significant. Other key secondary endpoints included PSA progression, and in the combination versus monotherapy ADT, the hazard ratio was .07, so very impressive difference. The time to a new antineoplastic therapy also was statistically and clinically meaningful as well, favoring combination enza/ADT and also favoring enza monotherapy. Safety signals were consistent with what we've known about enzalutamide, so when that was added in the combination or in the monotherapy enza arm, we saw some additional safety signals of fatigue and of falls, and a little bit more of gynecomastia, for sure in the enza monotherapy arm.

This transcription has been edited for clarity.

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