Study
Phase 2, randomized, open-label trial (JAVELIN Bladder Medley) |
Locally advanced or metastatic urothelial carcinoma without progression after first-line platinum-based chemotherapy |
Avelumab (800 mg q2w) + sacituzumab govitecan (10 mg/kg D1, D8 q3w) vs. Avelumab monotherapy (800 mg q2w) |
Efficacy
ORR: 24.3% vs. 2.7% (satituzumab + avelumab vs. avelumab alone) |
mDoR: 11.9 mos vs. not estimable |
mPFS: 11.17 mos vs. 3.75 mos (HR: 0.49 [0.31–0.76]) |
mOS: not reached vs. 23.75 mos (HR: 0.79 [0.42–1.50]) |
Safety
Grade ≥3 TRAEs: 79.5% vs. 36.1% |
G-CSF use: 48.6% vs. 2.7% |
Drug-related death: 1 patient (acute subarachnoid hemorrhage with sepsis) |
Ann Oncol 2025;35(7):in press
http://doi.org/10.1016/j.annonc.2025.05.010
Reviewed by Ulas D. Bayraktar, MD on Jun 2, 2025
