Summary

• No prospective, randomized, head-to-head clinical trials comparing the efficacy and safety of AKEEGA with enzalutamide have been conducted.
• ProBio (Prostate-Biomarker, NCT03903835) is an ongoing, phase 3, outcome-adaptive, multiarm, multiple-assignment, randomized, open-label, international biomarker-driven platform study in patients with de novo metastatic hormone-sensitive prostate cancer (mHSPC) or first-line (L1) metastatic castration-resistant prostate cancer (mCRPC). Patients will be randomized to receive either standard of care (SOC) or an experimental treatment including abiraterone acetate, AKEEGA, or enzalutamide based on predefined biomarker signatures. The study has a planned enrollment of 750 patients. The efficacy and safety results have not been published.^1,2
• Results from a matching-adjusted indirect comparison (MAIC) study that utilized data from the following phase 3 registrational studies in patients with L1 mCRPC have been reported:³ 
  • MAGNITUDE (AKEEGA and androgen deprivation therapy [ADT] vs placebo/abiraterone acetate plus prednisone [AAP] and ADT; homologous recombination repair [HRR] mutation population)
  • PROpel (olaparib plus AAP and ADT vs placebo plus AAP and ADT; all-comers population)
  • TALAPRO-2 (talazoparib plus enzalutamide and ADT vs placebo plus enzalutamide and ADT; all-comers population)

LITERATURE SEARCH

A literature search of MEDLINE^®, Embase^®, BIOSIS Previews^®, and Derwent Drug File (and/or other resources, including internal/external databases) was conducted on 05 June 2025. Summarized in this response are relevant data pertaining to this topic in patients with prostate cancer.