Patients with ALK-positive non-small cell lung cancer treated with ensartinib fared better and lived longer than those who received crizotinib, according to results of a phase 3 study. The randomized study compared the targeted therapies as first-line treatments. Ensartinib is a newer targeted therapy that was initially tested and validated at a Vanderbilt-Ingram Cancer Center research laboratory, while crizotinib received approval in 2011 from the U.S. Food and Drug Administration (FDA).
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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