Study
| Phase 3, randomized, open-label trial (TROPiCS-04) |
| Previously treated advanced urothelial carcinoma (progression after platinum-based chemotherapy and checkpoint inhibitor) |
| Sacituzumab govitecan vs. treatment of physician’s choice (paclitaxel, docetaxel, or vinflunine) |
Efficacy
| ORR: 23% vs. 14% |
| CR: 5% vs. 3% |
| mDoR: 7.2 mos vs. 6.5 mos |
| mPFS: 4.2 mos vs. 3.6 mos (HR: 0.86 [0.72-1.03]) |
| mOS: 10.3 mos vs. 9.0 mos (HR: 0.86 [0.73-1.02]) |
Safety
| Grade ≥3 AEs: Neutropenia (35% vs. not reported), febrile neutropenia (12% vs. not reported) |
| Any grade ≥3 TRAEs: 67% vs. 35% |
| Grade 5 TEAEs: 7% vs. 2% |
| Treatment-related discontinuations: 11% vs. 12% |
Ann Oncol 2025;35:1345-59
http://doi.org/10.1016/j.annonc.2025.01.011
Reviewed by Ulas D. Bayraktar, MD on Apr 7, 2025
