New Indication: Dabrafenib and Trametinib in bRAV V600E Mutant Anaplastic Thyroid Cancer
Study
Open-label, nonrandomized, phase II basket study
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Unresectable or metastatic 36 anaplastic thyroid cancer patients
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Dabrafenib 150 mg x 2 /day plus trametinib 2 mg/day
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Efficacy
ORR: 56% (95% CI, 38.1% to 72.1%), CR:3 patients
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12-month DOR: 50%.
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mPFS:6.7 m and mOS:14.5 m
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12 month PFS and OS: 43.2% and 51.7%
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Safety
All grades AEs: 75%
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Serious AEs: 56%
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Grade ≥3 AEs 58%, anemia:19%, pneumonia:19%, hyponatremia:17%
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Dabrafenib plus trametinib in patients with BRAF V600E-mutant anaplastic thyroid cancer: updated analysis from the phase II ROAR basket study.
Reviewed by Hasan Cagri Yildirim, MD on Sep 20, 2022