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New Indication: Dabrafenib and trametinib for unresectable or metastatic solid tumors

New Indication: Dabrafenib and trametinib for unresectable or metastatic solid tumors
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.

Subbiah, V et al. “Dabrafenib plus trametinib in patients with BRAF V600E-mutant anaplastic thyroid cancer: updated analysis from the phase II ROAR basket study.”

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

Reviewed by Hasan Çağrı Yıldırım, MD on Jul 06, 2022

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