A cancer drug that Eli Lilly was positioning as a challenger to similar drugs from rivals Pfizer and Novartis has failed a late-stage clinical trial in lung cancer.
Indianapolis-based Lilly (NYSE: LLY) said Tuesday that its drug, abemaciclib (Verzenio), did not meet the Phase 3 study’s main goal of improving overall survival in patients who have advanced non-small cell lung cancer.
Abemaciclib targets two enzymes, cyclin-dependent kinases 4 and 6 (CDK4/6), which help regulate cancer cell growth and division and are overactive in many cancers. Lilly says its drug binds to these enzymes, which disrupts the cell cycle of tumor cells, inhibiting their growth. Pfizer’s (NYSE: PFE) palbociclib (Ibrance) was the first CDK4/6 inhibitor to reach the market following its FDA approval in 2015 as a treatment for advanced breast cancer, and has since gone on to generate blockbuster sales topping $2 billion last year. In March, Novartis (NYSE: NVS) CDK4/6 inhibitor ribociclib (Kisqali) received an FDA nod in advanced breast cancer.
The FDA approved the Lilly drug late last month for advanced breast cancers, but the company had hoped to best its rivals by tacking on approvals in other cancers. Besides non-small cell lung cancer, Lilly said during its second quarter earnings conference call that it plans to test the drug in colorectal cancer, pancreas cancer, and advanced lung cancer.
In the failed non-small cell lung cancer trial, Lilly’s drug was tested head to head against erlotinib (Tarceva), a Roche drug, approved to treat the disease. The 453 patients in the trial were randomized to receive either the Lilly pill or the Roche drug. Lilly says the most common side effects observed in the study were diarrhea, fatigue, decreased appetite, and nausea.
Although abemaciclib did not improve overall survival for patients in the trial, Lilly says the drug did show antitumor activity and the company will study the data to evaluate the drug’s prospects non-small cell lung cancer. The company added that it has other ongoing studies of the drug in combination with other treatments for non-small cell lung cancer and other cancers. Lilly plans to present data from the failed trial at a medical meeting next year.
Lung cancer metastasis image by the National Cancer Institute.