New Indication: Trastuzumab Deruxtecan for her2 Mutant NSCLC


  • Study

    Multicenter, blinded, phase 2 study
    Previously treated (platinum-containing therapy) patients with HER2m mNSCLC
    Trastuzumab deruxtecan: 5.4 mg/kg (n=102) vs. 6.4 mg/kg (n=52)




  • Efficacy

    ORR: 49.0% vs. 56.0 %
    mDOR: 16.8 mos [6.4-NR] vs. NR [8.3-NR]
    mPFS: 9.9 mos vs. 15.4 mos
    12 mos PFS: 45 % vs. 53%
    mOS: 19.5 mos vs. NR
    12 mos OS: 67% vs. 73%



  • Safety

    Grade≥3 AEs: Neutropenia (18.8% vs 36.0%), anemia (10.9% vs. 16.0%), fatigue (7.9% vs. 10.0%).



  • Journal of Clin Oncol SEP, 2023

    Trastuzumab Deruxtecan in Patients With HER2-Mutant Metastatic Non–Small-Cell Lung Cancer: Primary Results From the Randomized, Phase II DESTINY-Lung02 Trial

    http://doi.org/10.1200/JCO.23.01361

    Reviewed by Elvin Chalabiyev, MD on Sep 23, 2023

    New Indication: Trastuzumab Deruxtecan for her2-Mutant NSCLC


  • Study

    Multicenter, international, phase 2 study
    Metastatic HER2-mutant NSCLC (refractory to standard treatment)
    Trastuzumab deruxtecan >= 6.4 mg per kilogram of body weight



  • Efficacy

    ORR: 55% (95% CI, 44 to 65)
    Median DOR: 9.3 months (95% CI, 5.7 to 14.7)
    Median PFS: 8.2 months (95% CI, 6.0 to 11.9)
    Median OS:17.8 months (95% CI, 13.8 to 22.1).



  • Safety

    Grade >=3 AEs: 46%, neutropenia 19%
    Drug-related interstitial lung disease: 26% => 2 death



  • N Engl J Med 2022; 386:241-251

    Trastuzumab Deruxtecan in HER2-Mutant Non–Small-Cell Lung Cancer

    http://doi.org/ 10.1056/NEJMoa2112431

    Reviewed by Hasan Cagri Yildirim, MD on Mar 16, 2022