New Reference: Zenocutuzumab for NRG1 Fusion-Positive Cancer


  • Study

    Phase 2, open-label, multicenter clinical trial (eNRGy)
    Advanced/metastatic solid tumors with NRG1 fusion
    Zenocutuzumab 750 mg IV every 2 weeks



  • Efficacy

    ORR: 30% (95% CI, 23–37)
    CR: 1 pt
    mDoR: 11.1 mos (95% CI, 7.4–12.9)
    mPFS: 6.8 mos (95% CI, 5.5–9.1)
    NSCLC ORR: 29% (95% CI, 20–39), mDoR: 12.7 mos (95% CI, 7.4–20.4)
    Pancreatic cancer ORR: 42% (95% CI, 25–59), mDoR: 7.4 mos (95% CI, 4.0–11.2)



  • Safety

    Grade ≥3 AEs: 14%
    Most common grade ≥3 AEs: Anemia (5%), GGT increase (4%), pneumonia (3%)
    Infusion-related reactions: 14% (all grade 1–2)
    Treatment-related grade ≥3 AEs: 7% (most common: diarrhea, anemia—3% each)
    Fatal AEs: 4% (none treatment-related)



  • N Engl J Med 2025;392:566-576

    Schram AM,Goto K,Kim DW Efficacy of Zenocutuzumab in NRG1 Fusion–Positive Cancer

    http://doi.org/10.1056/NEJMoa2405008

    Reviewed by Ulas D. Bayraktar, MD on Feb 7, 2025