A phase II study on BRAF V600E–mutant anaplastic thyroid cancer patients confirms the benefit of the treatment with dabrafenib plus trametinib: beside a good safety and tolerability profile, relevant clinical benefits have been shown in patients with this rare and aggressive tumor.
Data come from a basket study, the ROAR (Rare Oncology Agnostic Research) trial, that has been enrolling patients since 2014 in 27 cancer centers in 13 countries; patients share a common tumor characteristic – the BRAF v600E mutation – although they may have an array of different rare cancers. The updated analysis on anaplastic thyroid cancer, recently published on Annals of Oncology, includes 4 years of additional study follow-up data from 36 patients treated with the BRAF inhibitor dabrafenib and MEK inhibitor trametinib, the only guideline-recommended systemic therapy option specifically approved by regulatory authorities worldwide since 2018 for the treatment of advanced BRAF V600E–mutant anaplastic thyroid cancer. New data show a 56% overall response rate, including 3 complete responses; the 12-month duration of response rate was 50%. Median progression-free survival and overall survival were 6.7 and 14.5 months, respectively; 12-month progression-free survival and overall survival rates were 43.2% and 51.7%, and the 24-month overall survival rate was 31.5%, with adverse events consistent with the established tolerability profile of dabrafenib plus trametinib.
Authors say that these updated results confirm the substantial clinical benefit and tolerability of dabrafenib plus trametinib in BRAF V600E–mutant anaplastic thyroid cancer: the treatment notably improves long-term survival and thus represents a meaningful treatment option for patients with this rare, aggressive cancer.