BMS-986365 vs HLD-0915: Comparison Not Possible
No evidence exists comparing BMS-986365 to HLD-0915, and HLD-0915 does not appear in any available medical literature or guidelines.
BMS-986365: Available Evidence
BMS-986365 is a first-in-class androgen receptor ligand-directed degrader (AR LDD) with dual mechanism of action—AR degradation and antagonism—specifically developed for metastatic castration-resistant prostate cancer (mCRPC), not hepatitis B 1, 2, 3.
Clinical Profile of BMS-986365
Indication and Mechanism:
- BMS-986365 targets the androgen receptor through heterobifunctional degradation combined with competitive antagonism 3.
- Designed to overcome resistance to androgen receptor pathway inhibitors (ARPIs) in patients with mCRPC whose disease progressed after prior ARPI therapy 1, 2.
Clinical Efficacy:
- In heavily pretreated mCRPC patients (median 4 prior therapies), PSA50 response was 32% across doses of 400-900 mg twice daily, with 50% response at the 900 mg dose 2.
- Median radiographic progression-free survival was 6.3 months overall, and 8.3 months at 900 mg twice daily 2.
- Efficacy was observed regardless of AR ligand-binding domain mutation status, including wildtype AR 2, 3.
Safety Profile:
- Most common treatment-related adverse events were asymptomatic QT prolongation (47%) and bradycardia (34%) 2.
- The drug was well tolerated with a manageable safety profile in phase I trials 2.
- Maximum tolerated dose was not reached in dose escalation studies 2.
Current Development Status:
- A phase III randomized trial (rechARge, NCT06764485) is ongoing, comparing BMS-986365 versus investigator's choice (docetaxel or alternative ARPI) in approximately 960 patients with mCRPC 1.
HLD-0915: No Available Evidence
No medical literature, clinical trials, FDA approvals, or guideline mentions exist for HLD-0915 in the provided evidence or standard medical databases.
Critical Distinction
BMS-986365 is exclusively a prostate cancer therapeutic agent and has no role in hepatitis B treatment 1, 2, 3. The hepatitis B guidelines provided discuss entirely different agents (entecavir, tenofovir, lamivudine, adefovir, telbivudine) that are nucleoside/nucleotide analogues with completely different mechanisms of action 4.
Common Pitfall: Confusing BMS compound numbers with hepatitis B therapeutics. BMS-986001 was a thymidine analogue NRTI evaluated for HIV (not hepatitis B), which showed similar efficacy to tenofovir but was discontinued due to greater resistance and metabolic concerns 5. This is an entirely different compound from BMS-986365.