Alectinib versus crizotinib in untreated Asian patients with anaplastic lymphoma kinase-positive non-small-cell lung cancer (ALESIA): a randomised phase 3 study

Pakzad, 2015, The incidence and mortality of lung cancer and their relationship to development in Asia, Transl Lung Cancer Res, 4, 763 Chen, 2016, Cancer Statistics in China, 2015, CA Cancer J Clin, 66, 115, 10.3322/caac.21338 Chen, 2015, Epidemiology of lung cancer in China, Thorac Cancer, 6, 209, 10.1111/1759-7714.12169 Gridelli, 2014, ALK inhibitors in the treatment of advanced NSCLC, Cancer Treat Rev, 40, 300, 10.1016/j.ctrv.2013.07.002 Dearden, 2013, Mutation incidence and coincidence in non small-cell lung cancer: meta-analyses by ethnicity and histology (mutMap), Ann Oncol, 24, 2371, 10.1093/annonc/mdt205 Hallberg, 2013, Mechanistic insight into ALK receptor tyrosine kinase in human cancer biology, Nat Rev Cancer, 13, 685, 10.1038/nrc3580 Solomon, 2014, First-line crizotinib versus chemotherapy in ALK-positive lung cancer, N Engl J Med, 371, 2167, 10.1056/NEJMoa1408440 Katayama, 2012, Mechanisms of acquired resistance in ALK-rearranged lung cancers, Sci Trans Med, 4, 120, 10.1126/scitranslmed.3003316 Doebele, 2012, Mechanisms of resistance to crizotinib in patients with ALK gene rearranged non-small cell lung cancer, Clin Cancer Res, 18, 1472, 10.1158/1078-0432.CCR-11-2906 Kodama, 2014, Selective ALK inhibitor alectinib with potent antitumor activity in models of crizotinib resistance, Cancer Lett, 351, 215, 10.1016/j.canlet.2014.05.020 Gainor, 2016, Molecular mechanisms of resistance to first- and second-generation ALK inhibitors in ALK-rearranged lung cancer, Cancer Discov, 6, 1118, 10.1158/2159-8290.CD-16-0596 Hida, 2017, Alectinib versus crizotinib in patients with ALK-positive non-small-cell lung cancer (J-ALEX): an open-label, randomised phase 3 trial, Lancet, 390, 29, 10.1016/S0140-6736(17)30565-2 Peters, 2017, Alectinib versus crizotinib in untreated ALK-positive non-small-cell lung cancer, N Engl J Med, 377, 829, 10.1056/NEJMoa1704795 Camidge, 2018, Updated efficacy and safety data from the global phase III ALEX study of alectinib (ALC) vs crizotinib (CZ) in untreated advanced ALK+ NSCLC, J Clin Oncol, 36 Heinig, 2016, Bioanalysis of alectinib and metabolite M4 in human plasma, cross-validation and impact on PK assessment, Bioanalysis, 14, 1465, 10.4155/bio-2016-0068 Ou, 2016, Alectinib in crizotinib-refractory ALK-rearranged non-small-cell lung cancer: a phase II global study, J Clin Oncol, 34, 661, 10.1200/JCO.2015.63.9443 Wu, 2018, Results of PROFILE 1029, a Phase III comparison of first-line crizotinib vs chemotherapy in East Asian patients (pts) with ALK+ advanced non-squamous non-small cell lung cancer (NSCLC), J Thorac Oncol, 13, 1539, 10.1016/j.jtho.2018.06.012 Hsu, 2016, Population pharmacokinetics (popPK) and exposure-response (ER) analyses to confirm alectinib 600 mg BID dose selection in a crizotinib-progressed or intolerant population, J Clin Oncol, 34 Soria, 2017, First-line ceritinib versus platinum-based chemotherapy in advanced ALK-rearranged non-small-cell lung cancer (ASCEND-4): a randomised, open-label, phase 3 study, Lancet, 389, 917, 10.1016/S0140-6736(17)30123-X Camidge DR, Kim HR, Ahn MJ, et al. Brigatinib vs crizotinib in patients with ALK inhibitor-naive advanced ALK+ NSCLC: first report of a phase 3 trial (ALTA-1L). Presented at the IASLC 19th World Conference on Lung Cancer (WCLC); Toronto, Canada, Sept 23–26, 2018. Abstr PL02.03. Camidge, 2018, Brigatinib versus crizotinib in ALK-positive non-small-cell lung cancer, N Engl J Med, 379, 2027, 10.1056/NEJMoa1810171 Popat S, Kim HR, Ahn MJ, et al. Intracranial efficacy of brigatinib (BRG) vs crizotinib (CRZ) in the phase 3 ALTA-1L trial. Presented at the ESMO 2018 Congress; Munich, Germany: Oct 19–23, 2018. Abstr LBA58. Shaw AT, Bauer TM, Takahashi T, et al. First-line lorlatinib versus crizotinib for advanced anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer. Presented at the IASLC 19th World Conference on Lung Cancer (WCLC); Toronto, ON, Canada, Sept 23–26, 2018. Abstr P1.13–06.