New Protocol: Maintenance Sacituzumab Govitecan with Avelumab for Urothelial Carcinoma


  • 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

    Hoffman-Censits J,Tsiatas JM,Chang PMH Avelumab plus sacituzumab govitecan versus avelumab monotherapy as first-line maintenance treatment in patients with advanced urothelial carcinoma: JAVELIN Bladder Medley interim analysis

    http://doi.org/10.1016/j.annonc.2025.05.010

    Reviewed by Ulas D. Bayraktar, MD on Jun 2, 2025

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