Bavdegalutamide Plus Abiraterone in Metastatic Prostate Cancer: Phase Ib Safety and Activity Results

Bavdegalutamide (ARV-110) is an oral androgen receptor degraderdesigned to address resistance to androgen-receptor–targeted therapy in metastatic prostate cancer. In this phase 1b study, it was combined with abiraterone in patients whose disease was progressing on abiraterone, with the goal of testing safety, pharmacokinetics, and early signs of antitumor activity.

The trial enrolled 45 patients, including a small subset with androgen receptor ligand-binding domain mutations.No dose-limiting toxicities were observed, and bavdegalutamide did not appear to cause clinically meaningful drug–drug interactions with abiraterone. The most frequent treatment-related adverse events were fatigue and nausea, and most toxicities were low grade.

Efficacy results were encouraging for an early-phase study. PSA control was reported in 48.9% of patients, while 24.4% achieved a PSA50 response, including several patients with AR ligand-binding domain mutations. Median radiographic progression-free survival reached 16.3 months, suggesting the combination may have clinically relevant activity in a setting where resistance to hormonal therapy is a major challenge.

Overall, the findings support further study of bavdegalutamide plus abiraterone as a potential strategy for metastatic prostate cancer. The results are still preliminary, but they add to the growing interest in targeted protein degradation as a way to overcome androgen receptor–driven resistance.

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