BMS-986460 for Prostate Cancer
Critical Finding: No Approved Use
BMS-986460 is not an approved or guideline-recommended treatment for prostate cancer and should not be used in clinical practice. The evidence provided contains no information about BMS-986460 as a PSMA inhibitor or any other therapeutic agent for prostate cancer.
Clarification on PSMA-Targeted Therapies
The confusion may stem from PSMA-targeted treatments that ARE approved and guideline-recommended:
Approved PSMA-Targeted Radioligand Therapy
177Lu-PSMA-617 is the only approved PSMA-targeted therapy for adult patients with progressive PSMA-positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor pathway inhibition and taxane-based chemotherapy 1.
This therapy achieved an ESMO-MCBS score of 4, demonstrating a median overall survival gain of 4.0 months (11.3 months vs 7.3 months) with a hazard ratio of 0.62 (95% CI 0.52-0.74) 1.
Treatment requires PSMA expression on PET imaging without PSMA non-expressing lesions 1.
Current Treatment Sequence for mCRPC
For patients who have received both a novel androgen receptor axis inhibitor (abiraterone, apalutamide, darolutamide, or enzalutamide) and docetaxel, the recommended options are 1:
- 177Lu-PSMA-617 in men with PSMA-expressing cancer [I, A]
- Cabazitaxel [I, A; ESMO-MCBS score: 3]
Investigational PSMA Agents
BMS-986365 (CC-94676) is a dual androgen receptor ligand-directed degrader currently in phase I trials, showing PSA50 response of 32% across doses and 50% at the 900 mg dose in heavily pretreated patients 2.
This agent is NOT the same as BMS-986460 and remains investigational 2.
Clinical Recommendation
Use only guideline-recommended therapies: For PSMA-targeted treatment, prescribe 177Lu-PSMA-617 only after confirming PSMA-positive disease on PET imaging and after progression on both androgen receptor pathway inhibitors and taxane chemotherapy 1.