Sacituzumab Tirumotecan demonstrated promising antitumor activity in advanced urothelial carcinoma with an ORR of 31% and a mOS of 12.1 months. Safety profile was manageable with no treatment-related deaths or febrile neutropenia events, supporting further evaluation of this therapy.
Study
|
Phase 1/2 study [NCT04152499] |
| Advanced or metastatic urothelial carcinoma with progression after chemotherapy and checkpoint inhibitors |
| Sacituzumab tirumotecan monotherapy (n=49) at 5 mg/kg every 2 weeks
|
Efficacy
|
ORR: 31% |
| mPFS: 5.5 mos; 18-mo PFS: 26% |
| mOS: 12.1 mos; 18-mo OS: 33%
|
Safety
|
Grade >=3 AEs: Anemia (41%), Decreased neutrophil count (35%), Decreased white blood cell count (20%), Stomatitis (12%), Decreased platelet count (8%) |
| No treatment-related deaths or febrile neutropenia events reported
|
Ann Oncol. Published online 2025 Nov 17.
Zhu Y, Jiang S, Shi Y New Drug: Sacituzumab Tirumotecan for Advanced Urothelial Carcinoma
http://doi.org/10.1016/j.annonc.2025.11.013
Reviewed by Ulas D. Bayraktar, MD on Dec 8, 2025
