Dabrafenib and trametinib in BRAF V600E-mutant anaplastic thyroid cancer (ROAR)
In one of the most lethal cancers known, dabrafenib plus trametinib shrank BRAF-mutant anaplastic thyroid cancer in about two thirds of patients, leading to the first ever drug approval for the disease.
Overview
Anaplastic thyroid cancer cohort of the phase 2 ROAR basket trial: 16 patients with BRAF V600E-mutant locally advanced or metastatic anaplastic thyroid cancer treated with dabrafenib plus trametinib.
Objective response was 69 percent with responses lasting more than a year in most, twelve-month overall survival of about 80 percent in an updated analysis, and manageable toxicity; the approval followed in 2018.
- Objective response 69 percent (11 of 16).
- Median duration of response and survival substantially exceeding historical months.
Rapid BRAF testing is mandatory at diagnosis of anaplastic thyroid cancer, and BRAF-MEK inhibition, increasingly with pembrolizumab and as neoadjuvant therapy, is the standard for BRAF-mutant disease.
- Very small cohort; only about 40 percent of anaplastic thyroid cancers carry BRAF V600E.
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