Rapid Readouts: Treatment Preference Results From the Phase 2 ODENZA Trial

Neal Shore, MD, discusses data from the following presentation:

• ODENZA, a prospective, randomized, open-label, multicenter, crossover phase 2 trial of treatment preference between darolutamide and enzalutamide in men with asymptomatic or mildly symptomatic metastatic castrate-resistant prostate cancer (CRPC) (Shore, ASCO 2021, abstract 5046)
  • The study’s objective is to investigate preference of darolutamide vs enzalutamide treatment in men with asymptomatic or mildly symptomatic metastatic CRPC (NCT03314324).
  • Open-label, multicenter, crossover phase 2 trial:
    • Period A + B:
      • Comparator arm 1: darolutamide (1200 mg) 1x daily for 12 weeks

• Comparator arm 2: enzalutamide (160 mg) 1x daily for 12 weeks
• 2-week washout period between crossover from period A to B

• Primary end point: patient preference
• Secondary end points: reasons for patient preference; prostate-specific antigen (PSA) response

• Conclusions: Treatment preference
  • 48.5% of patients preferred treatment with darolutamide; 40.0% preferred enzalutamide
    • 11.5% of patients did not have a treatment preference for either darolutamide or enzalutamide.
  • Reasons given by patients for preferring darolutamide treatment included lower rates of fatigue, falls, and cognition impairment, as well as the ease of treatment regimen.
    • Fatigue was noted in 21% of patients treated with darolutamide vs 36% of those treated with enzalutamide.
• Conclusions: PSA decline
  • Similar rates in PSA decline were noted between darolutamide and enzalutamide.
    • A PSA50 response was achieved in 76.2% and 83.9% at 12 weeks with darolutamide and enzalutamide, respectively (P = .13).
• While treatment preference between darolutamide and enzalutamide did not reach statistical significance, a greater number of patients expressed a preference for treatment with darolutamide.
• Results from the ODENZA trial provide additional evidence for how patients respond to and tolerate the different treatments available for use in asymptomatic or mildly symptomatic metastatic CRPC.