New findings show that Ibrance has the potential to help patients with brain metastases that harbor a CDK pathway alteration.
In an interim analysis of a phase 2 study of Ibrance (palbociclib) researchers found the drug had a cranial benefit for patients with brain metastasis that harbored a cyclin-dependent kinases (CDK) pathway alteration, according to data presented at the 2019 Society for NeuroOncology Annual Meeting.
Ibrance is a CDK inhibitor that has shown positive results for HR-positive and HER2-negative breast cancer, but now shows promise for tackling brain metastasis that present this CDK pathway. In a genomically-guided trial, eight of the first 14 patients showed inter cranial benefit from the drug, according to Dr. Brastianos Priscilla.
Priscilla, director of the central nervous system metastasis program at Massachusetts General Hospital in Boston, had the chance to sit down with CURE and discuss the results of the phase 2 trial and what she believes this means for the future of Ibrance and treating patients with brain metastases.
This study design was a Simon Two-Stage design where we were to enroll 15 patients to start, and if at least two patients had clinical benefit intracranially than we would proceed to the second stage of a Simon Two-Stage design. And then finally, at 30 patients, if at least six patients out of the 30 had a clinical benefit intracranially, then the treatment would be considered worthy of further study.
With the interim analysis, we were able to review the first 14 invaluable cases, and of those patients, eight patients had a clinical benefit intracranially. Which means that number one, palbociclib shows promise in this patient population of patients with brain metastases harboring CDK pathway alterations. And number two, that running a gnomically guided brain metastases trial is feasible.