Verzenio for glioblastoma – pro
This drug is in a clinical study,.”A Study of Abemaciclib in Recurrent Glioblastoma, NCT02981940. This research study is a Phase 0/II clinical trial. Phase 0 clinical trials use only a few small doses of a drug. Phase II clinical trials test the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific disease. “Investigational” means that the drug is being studied.
The drug is E/I because it is in early clinical studies. Preliminary results of the INSIGHT phase II study showed that Abemaciclib was well-tolerated and prolonged PFS but there is no evidence of an overall survival improvement compared to standard radiochemotherapy.
The FDA (the U.S. Food and Drug Administration) has not approved abemaciclib as a treatment for any disease.
Many brain cancers show over expression of a protein called cyclin D1. That means that the body makes too much cyclin D1, which affects enzymes called CDK 4 and CDK 6. Enzymes are substances in the body that help reactions between cells happen. Too much cyclin D1 triggers CDK 4 and CDK 6 to make more cells than normal. This extra cell production leads to the growth of tumors. In laboratory studies, Abemaciclib was able to enter the brain, stop CDK 4 and CDK 6 from making cells, and slow growth of mice Glioblastoma.
In this research study, the investigators are looking to see how safe and effect Abemaciclib is with the participant type of cancer. In the surgical participants, the investigators are looking to see if Abemaciclib reached the brain tumor.
Eudocia Quant Lee et al, Preliminary results of the abemaciclib arm in the Individualized Screening Trial of Innovative Glioblastoma Therapy (INSIGhT): A phase II platform trial using Bayesian adaptive randomization.JCO.2021.39.15_suppl.2014 Journal of Clinical Oncology 39, no. 15_suppl (May 20, 2021) 2014-2014.
Hsieh TH, Liang ML, Zheng JH, Lin YC, Yang YC, Vo TH, Liou JP, Yen Y, Chen CH. Combining an Autophagy Inhibitor, MPT0L145, with Abemaciclib Is a New Therapeutic Strategy in GBM Treatment. Cancers (Basel). 2021 Dec 4;13(23):6117.