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New research · Oncology
The Lancet. Oncology · 1d
Randomized trialThe Lancet. Oncology · 2026

Efficacy and safety of dabrafenib plus trametinib in adults with differentiated thyroid cancer: a randomised, double-blind, placebo-controlled, phase 3 trial.

Ming Gao, Young Joo Park, Chia-Chi Lin … Lori J Wirth
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OncologyRandomized trial

Dabrafenib plus trametinib significantly improves progression-free survival in differentiated thyroid cancer.

Efficacy and safety of dabrafenib plus trametinib in adults with differentiated thyroid cancer: a randomised, double-blind, placebo-controlled, phase 3 trial.

Ming Gao et al. · The Lancet. Oncology · 2026
Background

In preliminary studies, dabrafenib plus trametinib showed clinically beneficial results in patients with radioactive iodine-refractory BRAF V600E -positive differentiated thyroid cancer.

Methods

Were randomly assigned (2:1) to receive either dabrafenib (150 mg orally; twice daily) plus trametinib (2 mg orally; once daily) or matching placebos.

n = 153 patients
HR 0·38
Results
the drug combination significantly reduced the chance of cancer progression or death
n = 153 patients
More results

73 (48%) participants were male and 80 (52%) participants were female, mean age was 62·6 years (SD 10·2), 18 (12%) participants were White, 131 (86%) were Asian, three (2%) were Black or African American, and one (1%) was from multiple races.

More results

Any-grade serious adverse events occurred in 43 (43%) patients in the dabrafenib plus trametinib group and 13 (25%) patients in the placebo group.

The most common adverse event in the dabrafenib plus trametinib group was pyrexia (n=48; 48%).

“
Conclusion · 1 of 2

In previously-treated patients with locally advanced or metastatic, radioactive iodine-refractory BRAF V600E -positive differentiated thyroid cancer, dabrafenib plus trametinib showed significant benefits for progression-free survival and overall response rate, with no new safety signals.

Conclusion · 2 of 2

These findings support the second-line use of dabrafenib plus trametinib in patients with radioactive iodine-refractory BRAF V600E -positive differentiated thyroid cancer.

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