Study
| Randomized , phase 2 trial |
| Patients with mCRPC who received prior androgen-receptor pathway inhibitors (ARPIs) and subsequently had nonprogressive disease on a taxane |
| Darolutamide (n=92) |
Efficacy
| 12 weeks rPFS: 64.7 vs 52.2%, p=0.127 |
| Median rPFS: 5.5 vs 4.5 mos , HR:0.54, p=0.017 |
| Median EFS: 5.4 vs. 2.9 mos, HR:0.46, p=0.001 |
| PSA 50% RR:22 vs. 4%, p=0.010 |
| Median OS: 24 vs. 21.3 mos,HR:0.62, p=0.181 |
Safety
| Any grade AEs: fatigue (9 vs.13%), nausea (7 vs. 4%), pruritus (4 vs. 0%) |
| Grade≥3 AEs: peripheral edema (2 vs. 0%) |
J Clin Oncol 2023; 10 FEB
http://doi.org/10.1200/JCO.22.01726
Reviewed by Elvin Chalabiyev, MD on Mar 15, 2023
