Phase 3 Trial Evaluates Rezvilutamide vs Enzalutamide in mHSPC

A pivotal new Chinese phase 3 clinical trial is poised to begin recruiting patients with metastatic hormone-sensitive prostate cancer to compare two leading androgen receptor antagonists head-to-head: rezvilutamide (SHR3680) versus enzalutamide in mHSPC. This trial represents an important milestone in prostate cancer therapeutics by directly evaluating the efficacy and safety of these oral treatments in combination with androgen deprivation therapy in the hormone-sensitive setting.

Rezvilutamide is a next-generation androgen receptor blocker designed to minimize penetration into the brain, thereby reducing neurologic side effects such as seizures and fatigue, which can compromise patient quality of life. In earlier studies and indirect comparisons, rezvilutamide demonstrated promising outcomes including a 42% reduction in mortality risk and a 56% reduction in radiographic progression risk relative to older treatment standards. These survival benefits, paired with a favorable safety profile, make rezvilutamide a compelling candidate to challenge the current standard bearer, enzalutamide.

Enzalutamide, a well-established androgen receptor antagonist, has demonstrated consistent efficacy in improving overall survival, radiographic progression-free survival, and PSA response in numerous trials. It is widely used in clinical practice, albeit with a known profile of adverse effects related to central nervous system penetration.

This upcoming randomized trial will assign participants to either rezvilutamide or enzalutamide, facilitating a rigorous, head-to-head comparison with the potential to refine therapeutic choice in metastatic hormone-sensitive prostate cancer. Outcomes will include progression-free and overall survival rates as well as patient-reported quality of life and side-effect profiles.

The direct comparison of rezvilutamide against enzalutamide marks an essential evolution in prostate cancer treatment research, aiming to provide more tailored and effective options with balanced tolerability.

Clinical trial.