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

Neal Shore, MD, presents data on treatment preferences from the phase 2 ODENZA trial of darolutamide and enzalutamide in men with asymptomatic or mildly symptomatic metastatic castrate-resistant prostate cancer. The results were reported at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting.

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    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.

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