Mature PFS data from ALEX confirmed significant improvement in PFS for alectinib over crizotinib in ALK-positive NSCLC. OS data remain immature, with a higher 5-year OS rate with alectinib versus crizotinib. This is the first global randomized study to show clinically meaningful improvement in OS for a next-generation tyrosine kinase inhibitor versus crizotinib in treatment-naive ALK-positive NSCLC. * Investigator-assessed PFS data in the ALEX study are now mature (53% of events in the alectinib arm). * Alectinib significantly prolonged PFS vs crizotinib (stratified HR 0.43, 95% CI 0.32–0.58; median 34.8 vs 10.9 months). * OS data are immature (37% of events); median NR alectinib vs 57.4 months crizotinib (stratified HR 0.67, 95% CI 0.46–0.98). * 5-year OS rate of 62.5% with alectinib and 45.5% with crizotinib. * Median treatment duration was longer with alectinib (28.1 vs 10.8 months crizotinib), with no new safety signals seen. READ ARTICLE
Annals of Oncology DOI: 10.1016/j.annonc.2020.04.478
Authors: T. Mok, D. R. Camidge, S. M. Gadgeel, R. Rosell, R. Dziadziuszko, D.-W. Kim, M. Pérol, S.-H. I. Ou, J. S. Ahn, A. T. Shaw, W. Bordogna, V. Smoljanovi, M. Hilton, T. Ruf, J. Noé, S. Peters