Abemaciclib, an oral drug administered twice daily, currently in development by Eli Lilly and Company (NYSE: LLY), has shown evidence of single-agent activity in patients with advanced non-small cell lung cancer in a Phase I study released ahead of the American Society of Clinical Oncology (ASCO) Annual Meeting to be held in Chicago, Ill. Also released was data from another cohort of this study which evaluated the safety of the combination of abemaciclib plus fulvestrant in women with hormone receptor positive metastatic breast cancer.
Cyclin-dependent kinases play a key role in regulating cell cycle progression. In many cancers, there is a loss of control in regulating the cell cycle in response to increased signaling from CDK 4/6. As a result, there is uncontrolled growth of cancer cells. Lilly's abemaciclib (LY2835219) is a cell-cycle inhibitor, designed to block the growth of cancer cells by specifically inhibiting CDK 4 and 6.
"These data add to the growing body of evidence to support our Phase III development of abemaciclib," said Richard Gaynor, M.D., senior vice president of product development and medical affairs for Lilly Oncology. "We currently have a Phase III program for breast cancer and plan to advance into Phase III for lung cancer yet this year."
A Phase I trial was conducted with expansion cohorts to evaluate the safety, pharmacokinetics (or how a body interacts with a drug) and antitumor activity of abemaciclib in five different tumor types, which include glioblastoma, melanoma, colorectal cancer, non-small cell lung cancer (NSCLC) and metastatic breast cancer.
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