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Xcovery's Ensartinib Extends PFS in First-Line Advanced ALK-Positive NSCLC

NEW YORK – Xcovery's ensartinib significantly extended progression-free survival in advanced, ALK-positive non-small cell lung cancer patients compared to crizotinib (Pfizer's Xalkori), researchers reported at a medical conference last week.

In the randomized, Phase III trial involving 247 NSCLC patients, those receiving the next-generation ALK inhibitor ensartinib in the first-line setting had median progression-free survival of 25.8 months at a median follow up of 23.8 months versus 12.7 months for patients on the first-generation ALK inhibitor crizotinib at a median follow up of 20.2 months. Leora Horn from Vanderbilt-Ingram Cancer Center presented the data at the International Association for the Study of Lung Cancer's World Conference on Lung Cancer on Friday.

"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 in a statement. "We're hoping that ensartinib will be another drug that receives US Food and Drug Administration approval for this indication for patients who are ALK positive."

Around 5 percent of NSCLC patients have ALK-positive tumors. In the Phase III study, patients had their ALK status confirmed using centralized testing with Abbott Molecular's Vysis ALK Break Apart FISH Probe Kit.

In the study, the overall response rate was 75 percent on the ensartinib arm versus 67 percent on the crizotinib arm. Among patients with brain metastases, intracranial responses were seen in 64 percent and 21 percent of patients on the ensartinib and crizotinib arms, respectively. Time-to-treatment failure in the group with brain metastases was 4 percent after a year of treatment with ensartinib compared to 24 percent with crizotinib.

In earlier studies, ensartinib has demonstrated efficacy in patients who have progressed on crizotinib, the first ALK inhibitor the FDA approved in 2011, as well as on second-generation ALK inhibitors.

Palm Beach Gardens, Florida-based Xcovery collaborated with researchers at Vanderbilt-Ingram Cancer Center to identify ensartinib as its lead drug development candidate and quickly advanced the agent into a global Phase III trial within six years. An Xcovery spokesperson said that the Phase III data presented at the lung cancer meeting will support a new drug application filing for ensartinib with the FDA.