ENfortumab vedotin head and neck

New Indication: Enfortumab Vedotin for Head and Neck Cancer


  • Study

    Open-label, multicohort, phase II study (EV-202)
    Recurrent/metastatic head and neck cancer previously treated with platinum-based chemotherapy and PD-1/PD-L1 inhibitors
    Enfortumab vedotin 1.25 mg/kg IV on days 1, 8, and 15 of each 28-day cycle



  • Efficacy

    ORR: 23.9%
    DCR: 56.5%
    mPFS: 3.9 mos
    mOS: 6.0 mos
    mDOR: 9.4 mos (at later data cutoff)



  • Safety

    Grade ≥3 AEs: anemia (4.3%), decreased neutrophil count (4.3%)
    Common AEs (any grade): alopecia (28.3%), fatigue (26.1%), peripheral sensory neuropathy (23.9%)
    Treatment-related deaths: 4.3%



  • J Clin Oncol 2024;43:578-88

    Swiecicki PL,Yilmaz E,Rosenberg AJ Phase II Trial of Enfortumab Vedotin in Patients With Previously Treated Advanced Head and Neck Cancer

    http://doi.org/10.1200/JCO.24.00646

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