rechARge: a randomized phase III trial of the androgen receptor ligand-directed degrader, BMS-986365, vs investigator's choice in patients with mCRPC.

📖 Top 20% JournalJun 2, 2025Future oncology (London, England)

Comparing a new androgen receptor blocker to standard treatments in advanced prostate cancer patients

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Abstract

Approximately 960 patients will be enrolled in a phase III trial evaluating BMS-986365 for .

BMS-986365 is a dual-action drug that targets the androgen receptor by both degrading and blocking it.
The trial compares BMS-986365 to standard therapies, including docetaxel and alternative .
Patients included in the trial have experienced disease progression after one prior treatment with an androgen receptor pathway inhibitor.
The primary objective is to evaluate the effectiveness and safety of BMS-986365 compared to the chosen standard therapies.

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There is an ongoing need for efficacious, life-prolonging therapies for males with (mCRPC). mCRPC that progresses after treatment with (ARPIs) may still be driven by AR signaling. BMS-986365 is a heterobifunctional, orally bioavailable ligand-directed degrader that targets the AR through a first-in-class dual mechanism of AR degradation and antagonism. Here, we present the study design of rechARge, a phase III, randomized, multicenter, adaptive, two-part, open-label trial evaluating BMS-986365 versus investigator's choice of therapy comprising either docetaxel or a switch to an alternative ARPI (abiraterone or enzalutamide) in patients with mCRPC whose disease has progressed after treatment with one prior ARPI. The primary study objective is to compare the efficacy and safety of BMS-986365 versus investigator's choice of therapy. Approximately 960 patients will be enrolled.www.clinicaltrials.gov identifier is NCT06764485. Clinical trial registration:

Key numbers

patients

960

median overall survival for post ARPI

2 years

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Abstract

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