Palbociclib Shows Promise for Treatment of Brain Metastases Harboring CDK Alterations

An interim analysis of the phase II study of palbociclib (Ibrance) for the treatment of patients with brain metastases harboring CDK alterations (NCT02896335) was presented at the 2019 Society for NeuroOncology Annual Meeting by Priscilla K. Brastianos, MD, director of the central nervous system brain metastasis program, Massachusetts General Hospital.

The study had a Simon 2-stage design. Fifteen patients were enrolled in the first stage of the trial. If at least 2 patients showed an intracranial clinical benefit, investigators would then proceed with the second stage of the study. In stage 2, if 6 out of 30 participants had a clinical benefit intracranially, then the treatment would be worthy of further study.

Brastianos says the trial was a genomically-guided trial in which patients were targeted based on the alterations found in their brain metastasis. Patients whose brain metastasis tissue harbored alterations in the CD4 pathway were given, CDK inhibitor, palbociclib. The results of this analysis showed that 8 out of the first 14 evaluable patients had clinical benefit intracranially.