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The Japanese trial that beat crizotinib with alectinib first, at half the dose used everywhere else, and was stopped early because the difference was so large.
J-ALEX recruited 207 ALK inhibitor-naive Japanese patients at 41 sites between November 2013 and August 2015 and randomised them 1:1 to alectinib 300 mg twice daily (103) or crizotinib 250 mg twice daily (104), stratified by performance status, treatment line and disease stage. The alectinib dose is half the 600 mg twice daily used in ALEX and ALESIA, because Japanese pharmacokinetic work had settled on it.
At the second interim analysis (data cutoff 3 December 2015) the independent data monitoring committee stopped the trial: 24 patients had discontinued alectinib against 61 on crizotinib, mostly for lack of efficacy or adverse events, and independently reviewed progression-free survival strongly favoured alectinib.
J-ALEX reported before ALEX and is the reason Japan approved alectinib first line at 300 mg twice daily while the rest of the world uses 600 mg. The two doses have never been compared head to head, and whether the higher one is necessary is still open.
Shares ALEX, Alectinib, Crizotinib, Brain metastases (intracranial disease).
Shares ALEX, Tyrosine kinase inhibitor (TKI), Crizotinib, Brain metastases (intracranial disease).
Shares PROFILE 1014, Crizotinib, Brain metastases (intracranial disease), ALK-positive non-small-cell lung cancer.
Shares ALEX, Tyrosine kinase inhibitor (TKI), Brain metastases (intracranial disease), ALK-positive non-small-cell lung cancer.
Shares Alectinib, ALK-positive non-small-cell lung cancer, Small-molecule kinase inhibitors.
Shares Crizotinib, Brain metastases (intracranial disease), ALK-positive non-small-cell lung cancer, ALK.
Shares Alectinib, ALK-positive non-small-cell lung cancer, ALK, Small-molecule kinase inhibitors.
Shares Alectinib, Crizotinib, ALK.