Efficacy and safety of dabrafenib plus trametinib in adults with differentiated thyroid cancer: a randomised, double-blind, placebo-controlled, phase 3 trial.
This global phase 3, double-blind, placebo-controlled trial randomized 153 previously treated patients with BRAF V600E-positive RAI-refractory differentiated thyroid cancer 2:1 to dabrafenib plus trametinib or placebo, demonstrating a 3.5-fold improvement in median PFS (12.8 vs 3.7 months) and a 57% objective response rate versus 4% with placebo. The consistent benefit and manageable safety profile support this BRAF/MEK inhibitor combination as a new second-line standard for this genomically defined thyroid cancer subtype.
This global phase 3, double-blind, placebo-controlled trial randomized 153 previously treated patients with BRAF V600E-positive RAI-refractory differentiated thyroid cancer 2:1 to dabrafenib plus trametinib or placebo, demonstrating a 3.5-fold improvement in median PFS (12.8 vs 3.7 months) and a 57% objective response rate versus 4% with placebo. The consistent benefit and manageable safety profile support this BRAF/MEK inhibitor combination as a new second-line standard for this genomically defined thyroid cancer subtype.
What the study was
- Study design
- Phase 3 randomized double-blind placebo-controlled trial
- Population
- Previously treated adults with locally advanced/metastatic BRAF V600E-positive RAI-refractory differentiated thyroid cancer (n=153)
- Sample size
- 153
- Category
- Treatment Innovation
- Maturity
- Potentially Practice-Changing
- Journal
- The Lancet. Oncology
Why it surfaced
First phase 3 RCT of BRAF+MEK inhibition in thyroid cancer; strongly positive result (HR 0.38, ORR 57%) in a population with very limited options after RAI failure, establishing a precision oncology standard for BRAF V600E-positive DTC.
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