BRAF/MEK Combo Might Increase Survival in Patients With Anaplastic Thyroid Cancer

Yuliya Mikheeva, MD, PhD, of Saint Petersburg State University, discusses how the development of the phase 2 ANAPLAST-NEO study (NCT04739566) for patients with anaplastic thyroid cancer (ATC) came to be.

ATC is an aggressive cancer which has a poor prognosis and survival rate of only 3 to 5 months with treatment. Novel therapies for this patient population are needed, especially for those with a BRAF mutation.

The phase 2 ANAPLAST-NEO study (NCT04739566) was created to test the efficacy of dabrafenib (Tafinlar), a BRAF inhibitor, and trametinib (Mekinist), a MEK inhibitor, combination as a neoadjuvant strategy in BRAF-positive ATC. The study included about 18 participants with an estimated study completion date of January 2026.

Primary end points are overall response rate and the number of R0 resections after 3 months of neoadjuvant combination therapy with secondary end points consisting of safety, complete response rate, health-related quality of life, progression-free survival, and overall survival.

Transcription:

0:08 | The idea of this study was born when we met our non-metastatic patient with anaplastic thyroid cancer with BRAF mutation. And, of course, we know about several cases where some patients were treated with anti-BRAF therapy in the neoadjuvant strategy, and we decided to design a trial. The combination of dabrafenib and trametinib in a neoadjuvant strategy of BRAF-positive anaplastic thyroid cancer and we have some good results.

1:07 | Our first patient that we met 2 years ago, and she's now with a very good quality of life without progression. That's why we decided to try and find more patients with whom we can help with such a trial. Unfortunately, this therapy is not approved in Russia. The FDA approved it for patients with metastatic disease, and it is not approved in Russia for neoadjuvant therapy. That's why the only choice to treat people with such cancer is in our trial.