Study
| Double-blind, placebo-controlled phase 3 trial (TALAPRO-2) |
| Previously untreated, CRPC |
| Enzalutamide + talazoparib (n=402) vs. Enzalutamide+ PBO (n=403 |
Efficacy
| ITT: |
| mrPFS: NR [27.5 mos-NR] vs 21.9 mos, HR:0.63, p<0.0001 |
| HRRm subgroup |
| mrPFS: 27.9 vs 16.4 mos, HR:0.45, p=0.0003 |
| HRR non-deficient or unknown subgroup |
| mrPFS: NR [27.5 vs NR] vs 22.5 mos, HR:0.70, p=0.003 |
Safety
| Grade≥3 AEs: Anemia (15.1% vs 3.3%), hypertension (3.5% vs 3.3%), venous emboli and thrombosis (6.8% vs 2.0%) |
Lancet Oncol 2023 Jul 22;402(10398):291-303
http://doi.org/10.1016/S0140-6736(23)01055-3
Reviewed by Elvin Chalabiyev, MD on Jun 24, 2023
