New Indication: Dabrafenib and Trametinib in bRAV V600E Mutant Anaplastic Thyroid Cancer


  • Study

    Open-label, nonrandomized, phase II basket study
    Unresectable or metastatic 36 anaplastic thyroid cancer patients
    Dabrafenib 150 mg x 2 /day plus trametinib 2 mg/day



  • Efficacy

    ORR: 56% (95% CI, 38.1% to 72.1%), CR:3 patients
    12-month DOR: 50%.
    mPFS:6.7 m and mOS:14.5 m
    12 month PFS and OS: 43.2% and 51.7%



  • Safety

    All grades AEs: 75%
    Serious AEs: 56%
    Grade ≥3 AEs 58%, anemia:19%, pneumonia:19%, hyponatremia:17%



  • Ann Oncol. 2022 Apr;33(4):406-415

    Dabrafenib plus trametinib in patients with BRAF V600E-mutant anaplastic thyroid cancer: updated analysis from the phase II ROAR basket study.

    http://doi.org/10.1016/j.annonc.2021.12.014

    Reviewed by Hasan Cagri Yildirim, MD on Sep 20, 2022