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WCLC 2020: Ensartinib Versus Crizotinib in First-Line Treatment of ALK-Positive NSCLC

By: Julia Fiederlein
Posted: Friday, August 14, 2020

Ensartinib appears to provide a longer progression-free survival than crizotinib in patients with locally advanced or metastatic ALK-positive non–small cell lung cancer (NSCLC), according to Leora Horn, MD, MS, of the Vanderbilt-Ingram Cancer Center, Nashville, and colleagues. The results of the phase III eXalt3 trial, which were presented during the virtual 2020 International Association for the Study of Lung Cancer (IASLC) World Conference on Lung Cancer (WCLC) Singapore (Abstract 2), seem to support a favorable safety profile for this novel second-generation ALK tyrosine kinase inhibitor. Final results from this trial, which are expected later in the year, may indicate whether this agent may offer a survival advantage over crizotinib. 

A total of 290 patients with locally tested ALK-positive NSCLC were enrolled in the intention-to-treat (ITT) population; they were randomly assigned in a 1:1 ratio to receive oral ensartinib (n = 143) or crizotinib (n = 147). The modified ITT population included 247 patients with centrally confirmed ALK gene rearrangements. All enrolled patients had not received prior ALK-targeted tyrosine kinase inhibitor therapy.

Progression-free survival events occurred in 73% of the ITT population and in 63% of the modified ITT population. The investigators reported a significantly longer median progression-free survival with ensartinib, compared with crizotinib (25.8 vs. 12.7 months; P = .0003). In the modified ITT population, the median progression-free survival was not reached with ensartinib and was 12.7 months with crizotinib.

The objective response rates with ensartinib and crizotinib were 75% versus 67%, respectively, in the modified ITT population. In patients with brain metastases, the intracranial objective response rate was 54% with ensartinib and 19% with crizotinib. In patients with no baseline brain metastases, the time to treatment failure rate in the brain was lower with ensartinib than with crizotinib (4% vs. 24%; P = .0016). In both arms of the modified ITT population, the 24-month overall survival rate was 78%.

Disclosure: The study authors reported no conflicts of interest.



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