xaluritamig (AMG 509)

These collective findings suggest the potential of immunotherapy for CRPC in overcoming resistance barriers and improving patient outcomes, with bispecific T cell engagers (Xaluritamig, 59% PSA50) and PSMA-directed CAR-T therapy (P-PSMA-101, >50% PSA reduction) emerging as the most promising near-term candidates and biomarker-stratified combinations (nivolumab plus rucaparib, 84.6% PSA50, in HRR-deficient patients) illustrating the transformative power of precision patient selection; however, these findings require validation in larger, biomarker-stratified trials before definitive conclusions can be drawn. Translating this potential into clinical reality requires optimized patient selection through predictive biomarkers and rigorously validated Phase III trials to confirm durable clinical responses and long-term survival benefits.

P1, N=40, Not yet recruiting, Amgen

P3, N=675, Active, not recruiting, Amgen | Recruiting --> Active, not recruiting

P1, N=50, Recruiting, Amgen | Not yet recruiting --> Recruiting

P2/3, N=295, Recruiting, Amgen Inc.

P1, N=50, Not yet recruiting, Amgen | Trial completion date: Jul 2029 --> Apr 2030 | Trial primary completion date: Jul 2029 --> Apr 2030

P1, N=50, Active, not recruiting, Amgen | Recruiting --> Active, not recruiting | Trial completion date: Jun 2029 --> Dec 2028 | Trial primary completion date: Apr 2027 --> Oct 2026

P3, N=750, Recruiting, Amgen | Trial primary completion date: Aug 2028 --> Jan 2030

P1, N=50, Not yet recruiting, Amgen

P1, N=40, Recruiting, Amgen | Trial primary completion date: Sep 2026 --> Jan 2027

P1, N=50, Recruiting, Amgen | Trial primary completion date: Dec 2026 --> Apr 2027

STEAP1 represents a promising diagnostic and therapeutic target in prostate cancer, and its potential role in shaping future management of the disease warrants continued investigation.