POLARIS was a study to evaluate different doses of encorafenib plus binimetinib for people with BRAF V600-mutant melanoma with brain metastasis. The first part, known as the safety lead-in, looked at a high dose of encorafenib (300 mg twice daily) combined with standard binimetinib (45 mg twice daily); in the phase 2 part, patients were given the standard dose of encorafenib (450 mg once daily) plus binimetinib. In the safety lead-in, many patients were unable to tolerate the high dose of encorafenib plus binimetinib. Despite recruitment challenges in POLARIS, in the 13 enrolled patients with unresectable metastatic BRAF V600-mutant melanoma with brain metastases, treatment with encorafenib plus binimetinib demonstrated intracranial activity, with a brain metastasis response rate of over 60%.

Source:

Menzies, A. M., & Davies, M. A. (2025). POLARIS: encorafenib plus binimetinib for people with BRAF V600-mutant melanoma with brain metastasis. Future Oncology, 21(16), 1961–1963. https://doi.org/10.1080/14796694.2025.2514426

https://www.tandfonline.com/doi/full/10.1080/14796694.2025.2514426#abstract