Astellas announced positive topline results from the phase 3 EMBARK trial evaluating Enzalutamide in men with non-metastatic hormone-sensitive prostate cancer (nmHSPC; also known as non-metastatic castration-sensitive prostate cancer or nmCSPC) with high-risk biochemical recurrence (BCR).
Patients enrolled in the trial were randomised to one of three study arms: Enzalutamide plus leuprolide, placebo plus leuprolide, or Enzalutamide monotherapy. The study met its primary endpoint with a statistically significant and clinically meaningful improvement in metastasis-free survival (MFS) for patients treated with Enzalutamide plus leuprolide versus placebo plus leuprolide.
At the time of the analysis, a positive trend in the key secondary endpoint of overall survival (OS) was also observed, but these data were not yet mature. Patients in the trial will be followed for a subsequent final OS analysis. The study also met a key secondary endpoint with a statistically significant and clinically meaningful improvement in MFS for patients treated with Enzalutamide monotherapy versus placebo plus leuprolide. Additional key secondary endpoints reached statistical significance, including time to PSA progression and time to first use of new antineoplastic therapy. Other secondary endpoints are being analysed. No new safety signals have been observed to date in the preliminary safety analysis, which is consistent with the established safety profile of Enzalutamide.
Detailed results from EMBARK will be presented at a future medical meeting. These data will also be discussed with regulatory authorities.
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