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Bending the Curve Trial by Trial
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EMBARK

Improved Outcomes with Enzalutamide in Biochemically Recurrent Prostate Cancer

Phase 3N = 1,068NCT02319837

Population
Men with prostate cancer and high-risk biochemical recurrence (PSA doubling time 9 months or less)
Design
Phase 3 trial, 1:1:1 randomization to enzalutamide 160 mg daily plus leuprolide every 12 weeks (combination), placebo plus leuprolide (leuprolide alone), or enzalutamide monotherapy. Eligibility: high-risk biochemical recurrence with PSA doubling time of 9 months or less. Primary end point metastasis-free survival by blinded independent central review, combination versus leuprolide alone; a key secondary end point was monotherapy versus leuprolide alone.
Primary endpoint
MFS
Arms
  • Placebo plus leuprolide (control, n = 358): Placebo plus leuprolide every 12 weeks
  • Enzalutamide plus leuprolide (experimental, n = 355): Enzalutamide 160 mg daily plus leuprolide every 12 weeks
  • Enzalutamide monotherapy (experimental, n = 355): Enzalutamide 160 mg daily
People
Freedland SJ, EMBARK
MFSHR 0.42 (95% CI 0.30–0.61)Δ 60-month MFS+15.9 pointsMFSHR 0.63 (95% CI 0.46–0.87)Δ 60-month MFS+8.6 points
Show the numbers
Results reported for EMBARK
EndpointAnalysisEnzalutamide plus leuprolide / Enzalutamide monotherapyPlacebo plus leuprolideEffect
MFSRandomized patients (analysis population not stated in the abstract)primarymedian follow-up 60.7 monthsFreedland 202387.3% at 5 y (83.0–90.6%)71.4% at 5 y (65.7–76.3%)HR 0.42 (95% CI 0.30–0.61)P<0.001Landmarks are metastasis-free survival at 5 years. Hazard ratio for metastasis or death, enzalutamide plus leuprolide versus leuprolide alone.
MFSRandomized patients (analysis population not stated in the abstract)primarymedian follow-up 60.7 monthsFreedland 202380% at 5 y (75.0–84.1%)71.4% at 5 y (65.7–76.3%)HR 0.63 (95% CI 0.46–0.87)P=0.005Key secondary end point. Landmarks are metastasis-free survival at 5 years. Hazard ratio for metastasis or death, enzalutamide monotherapy versus leuprolide alone.
Results reported for EMBARK
EndpointAnalysisEnzalutamide plus leuprolide / Enzalutamide monotherapyPlacebo plus leuprolideEffect
MFSRandomized patients (analysis population not stated in the abstract)primarymedian follow-up 60.7 monthsFreedland 202387.3% at 5 y (83.0–90.6%)71.4% at 5 y (65.7–76.3%)HR 0.42 (95% CI 0.30–0.61)P<0.001Landmarks are metastasis-free survival at 5 years. Hazard ratio for metastasis or death, enzalutamide plus leuprolide versus leuprolide alone.
MFSRandomized patients (analysis population not stated in the abstract)primarymedian follow-up 60.7 monthsFreedland 202380% at 5 y (75.0–84.1%)71.4% at 5 y (65.7–76.3%)HR 0.63 (95% CI 0.46–0.87)P=0.005Key secondary end point. Landmarks are metastasis-free survival at 5 years. Hazard ratio for metastasis or death, enzalutamide monotherapy versus leuprolide alone.
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
MFSMFS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
MFS0.420.3–0.61
MFS0.630.46–0.87
Primary publication: Freedland SJ, de Almeida Luz M, De Giorgi U, Gleave M, Gotto GT, Pieczonka CM, et al. Improved Outcomes with Enzalutamide in Biochemically Recurrent Prostate Cancer. N Engl J Med. 2023;389(16):1453-1465. PubMedDOI

Appears in

Sources

  1. Freedland SJ, de Almeida Luz M, De Giorgi U, Gleave M, Gotto GT, Pieczonka CM, et al. Improved Outcomes with Enzalutamide in Biochemically Recurrent Prostate Cancer. N Engl J Med. 2023;389(16):1453-1465.

    PubMedDOI