Leora Horn, MD, MSc, Ingram Professor of Cancer Research, presented the results of the phase 3 clinical trial Saturday at the International Association for the Study of Lung Cancer World Conference on Lung Cancer Virtual Presidential Symposium. The progression-free results for ensartinib were double that of crizotinib (25.8 months compared to 12.7 months).
“Ensartinib showed a significant improvement in progression-free survival compared to crizotinib, much better control of central nervous system disease and a really good safety profile,” Horn said. “We’re hoping that ensartinib will be another drug that receives FDA approval for this indication for patients who are ALK positive.”
Approximately 5% to 7% of patients with non-small cell lung cancer have the ALK-positive form of disease, which often occurs in younger people and has no known correlation to smoking or environmental toxins. Prior phase 1 and phase 2 clinical trials have shown that ensartinib was effective for patients whose lung cancer had progressed on crizotinib as well as second generation ALK inhibitors. The time-to-treatment failure rate in the brain in patients with no baseline metastases was significantly lower with ensartinib, 4% at 12 months compared to 24% for crizotinib.
Horn collaborates with Christine Lovly, MD, PhD, associate professor of Medicine, who operates a research laboratory at Vanderbilt-Ingram. The drug company Xcovery had designed several potential ALK drugs and approached Vanderbilt about doing pre-clinical studies. Lovly identified ensartinib as the lead compound. The researchers were able to spur rapid development of the drug that led to the global phase 3 trial within six years. Xcovery sponsored the trial.
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