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ENZAMET

Enzalutamide with Standard First-Line Therapy in Metastatic Prostate Cancer

Phase 3N = 1,125NCT02446405

Population
Men with metastatic hormone-sensitive prostate cancer (median age 69 years)
Design
Open-label randomized (1:1) phase 3 trial (ANZUP 1304; also ANZCTR ACTRN12614000110684 and EU Clinical Trials Register 2014-003190-42): testosterone suppression plus enzalutamide 160 mg daily or plus a standard non-steroidal antiandrogen (bicalutamide, nilutamide or flutamide). Concurrent docetaxel (75 mg/m2, up to six cycles) was allowed at the discretion of participants and physicians. Primary end point overall survival.
Primary endpoint
OS
Arms
  • Testosterone suppression plus standard non-steroidal antiandrogen (control, n = 562): Testosterone suppression plus bicalutamide, nilutamide or flutamide
  • Testosterone suppression plus enzalutamide (experimental, n = 563): Testosterone suppression plus enzalutamide 160 mg once daily
People
Davis ID, ENZAMET (ANZUP 1304)
OSHR 0.67 (95% CI 0.52–0.86)Δ 36-month OS+8 pointsOSHR 0.70 (95% CI 0.58–0.84)Δ 60-month OS+10 points
Show the numbers
Results reported for ENZAMET
EndpointAnalysisTestosterone suppression plus enzalutamideTestosterone suppression plus standard non-steroidal antiandrogenEffect
OSRandomized men (analysis population not stated in the NEJM abstract)interimmedian follow-up 34 monthsDavis 201980% at 3 y72% at 3 yHR 0.67 (95% CI 0.52–0.86)P=0.002143 deaths in the standard-care group and 102 in the enzalutamide group. Landmarks are Kaplan-Meier overall survival at 3 years.
OSprimarymedian follow-up 68 monthsSweeney 202367% at 5 y57% at 5 yHR 0.70 (95% CI 0.58–0.84)P<0.0001Planned primary overall survival analysis, triggered on 19 January 2022 at 476 deaths (42%); median overall survival not reached. Landmarks are 5-year overall survival; the abstract prints their 95% confidence intervals as decimals, 0.53-0.61 (control) and 0.63-0.70 (enzalutamide).
Results reported for ENZAMET
EndpointAnalysisTestosterone suppression plus enzalutamideTestosterone suppression plus standard non-steroidal antiandrogenEffect
OSRandomized men (analysis population not stated in the NEJM abstract)interimmedian follow-up 34 monthsDavis 201980% at 3 y72% at 3 yHR 0.67 (95% CI 0.52–0.86)P=0.002143 deaths in the standard-care group and 102 in the enzalutamide group. Landmarks are Kaplan-Meier overall survival at 3 years.
OSprimarymedian follow-up 68 monthsSweeney 202367% at 5 y57% at 5 yHR 0.70 (95% CI 0.58–0.84)P<0.0001Planned primary overall survival analysis, triggered on 19 January 2022 at 476 deaths (42%); median overall survival not reached. Landmarks are 5-year overall survival; the abstract prints their 95% confidence intervals as decimals, 0.53-0.61 (control) and 0.63-0.70 (enzalutamide).
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
OSOS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
OS0.670.52–0.86
OS0.70.58–0.84
Primary publication: Davis ID, Martin AJ, Stockler MR, Begbie S, Chi KN, Chowdhury S, et al. Enzalutamide with Standard First-Line Therapy in Metastatic Prostate Cancer. N Engl J Med. 2019;381(2):121-131. PubMedDOI

Appears in

Sources

  1. Davis ID, Martin AJ, Stockler MR, Begbie S, Chi KN, Chowdhury S, et al. Enzalutamide with Standard First-Line Therapy in Metastatic Prostate Cancer. N Engl J Med. 2019;381(2):121-131.

    PubMedDOI

  2. Sweeney CJ, Martin AJ, Stockler MR, Begbie S, Cheung L, Chi KN, et al. Testosterone suppression plus enzalutamide versus testosterone suppression plus standard antiandrogen therapy for metastatic hormone-sensitive prostate cancer (ENZAMET): an international, open-label, randomised, phase 3 trial. Lancet Oncol. 2023;24(4):323-334.

    PubMedDOI