Yuliya Mikheeva, MD

Yuliya Mikheeva, MD, PhD, of Saint-Petersburg State University, discusses the design of the phase 2 ANAPLAST-NEO study (NCT04739566).

The open-label, single-arm, non-randomized study looks to test the efficacy of the combination of dabrafenib (Tafinlar), a BRAF inhibitor, and a MEK inhibitor as a neoadjuvant strategy in BRAF-positive anaplastic thyroid cancer (ATC). Currently, the study has an estimated enrollment of 18 participants, and an estimated primary completion date of January, 2024.

Eligibility in the trial was open to patients with histologically confirmed disease BRAF-positive ATC with the absence of metastases in the brain, as well as normal organ and bone marrow function.

Primary end points of the trial include overall response rate and the number of R0 resections after 3 months of neoadjuvant combination therapy with anti-BRAF and MEK inhibitors. The secondary end points being studied consist of safety, complete response rate, health-related quality of life, progression-free survival, and overall survival.

It's a phase 2 single-center, open-label, single-arm, non-randomized study. Our primary end points are objective response rate, and number of 0 resections after 3 months of neoadjuvant combination therapy with anti-BRAF and MEK inhibitors. Secondary end points are safety profile, health-related quality of life, progression- free survival, and overall survival.

 The inclusion criteria is any male or female that are over 18 years or years old, and in good performance status. Patients must have histologically confirmed disease, BRAF-positive anaplastic thyroid cancer, determined by immunohistochemistry of the presence of BRAF with a V600E mutation in tumor tissue, they must have the ability of swallow tablets and capsules or gastrectomy, the absence of metastases in the brain and normal organ and bone marrow function.

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Yuliya Mikheeva, MD, PhD, discusses the design of the phase 2 ANAPLAST-NEO study

Design of the ANAPLAST-NEO Study for 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.

 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.

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.

Yuliya Mikheeva, MD,  discusses the phase 2 ANAPLAST-NEO study  for patients with anaplastic thyroid cancer.


Yuliya Mikheeva, MD | Authors

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