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Enzalutamide in biochemically recurrent prostate cancer: clinical implications from EMBARK for real-world practice.

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Area of Science:

  • Oncology
  • Urology

Background:

  • The EMBARK phase 3 trial previously showed enzalutamide plus leuprolide and enzalutamide monotherapy improved metastasis-free survival in biochemically recurrent prostate cancer.
  • The final overall survival (OS) data from the EMBARK trial were pending.

Purpose of the Study:

  • To report the final overall survival (OS) results from the EMBARK trial.
  • To compare the efficacy of enzalutamide plus leuprolide versus leuprolide alone, and enzalutamide monotherapy versus leuprolide alone in patients with high-risk biochemically recurrent prostate cancer.

Main Methods:

  • A randomized, 1:1:1 trial involving patients with high-risk biochemically recurrent prostate cancer.
  • Treatment arms included enzalutamide plus leuprolide, leuprolide alone, and enzalutamide monotherapy.
  • Overall survival was a key secondary endpoint, analyzed with alpha control.

Main Results:

  • Eight-year OS was 78.9% for enzalutamide plus leuprolide versus 69.5% for leuprolide alone (hazard ratio [HR] for death: 0.60; P<0.001).
  • Eight-year OS for enzalutamide monotherapy was 73.1%, not significantly different from leuprolide alone (HR: 0.83; P=0.19).
  • Safety findings were consistent with previous analyses.

Conclusions:

  • The combination of enzalutamide and leuprolide significantly improved overall survival in patients with high-risk biochemically recurrent prostate cancer.
  • Enzalutamide monotherapy did not demonstrate superiority over leuprolide alone in terms of overall survival.