1L Clinical Trial: The primary efficacy endpoint in the ALEX trial was PFS by Investigator (HR=0.48 [95% CI: 0.35, 0.66]; P<0.0001). Additional efficacy endpoints were PFS, ORR, DOR, time to cause-specific CNS progression by IRC, and OS.2
aThe exploratory follow-up, conducted 10 months later, was assessed by investigators, and no formal treatment comparisons were performed.2,4,20
84% reduction in risk of tumors spreading to or growing in the CNS as the first site of progression (HR=0.16 [95% CI: 0.10, 0.28]); P<0.0001b
All exploratory analyses are descriptive in nature. Subgroups were not powered to show differences between treatment arms.16
aSystemic progression without prior CNS progression (ALECENSA n=36; crizotinib n=33); death prior to CNS or systemic progression (ALECENSA n=11; crizotinib n=9).4
bCause-specific HR and 95% CI were estimated by Cox model where patients with competing events (systemic progression and death prior to CNS or systemic progression) were censored at the time of these events. P-values were estimated from two-sided stratified cause-specific log-rank tests.18
cExcludes 1 patient in the ALECENSA arm with no CNS metastases by IRC who had received prior radiotherapy.17
All exploratory analyses are descriptive in nature. Subgroups were not powered to show differences between treatment arms.16
1L=first-line; CI=confidence interval; CNS=central nervous system; CR=complete response; HR=hazard ratio; IRC=Independent Review Committee; ORR=objective response rate; PFS=progression-free survival.
IQVIA US Claims, January 2021-December 2022.
IQVIA US Claims, January 2021-December 2022.
ALECENSA [prescribing information]. South San Francisco, CA: Genentech USA, Inc; 2021.
ALECENSA [prescribing information]. South San Francisco, CA: Genentech USA, Inc; 2021.
Peters S, Camidge DR, Shaw AT, et al. Alectinib versus crizotinib in untreated ALK-positive non–small cell lung cancer. N Engl J Med. 2017;377:829-838.
Peters S, Camidge DR, Shaw AT, et al. Alectinib versus crizotinib in untreated ALK-positive non–small cell lung cancer. N Engl J Med. 2017;377:829-838.
Data on file. Genentech, Inc.
Data on file. Genentech, Inc.
Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Non-Small Cell Lung Cancer V.3.2023. © National Comprehensive Cancer Network, Inc. 2023. All rights reserved. Accessed April 20, 2023. To view the most recent and complete version of the guideline, go online to NCCN.org.
Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Non-Small Cell Lung Cancer V.3.2023. © National Comprehensive Cancer Network, Inc. 2023. All rights reserved. Accessed April 20, 2023. To view the most recent and complete version of the guideline, go online to NCCN.org.
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Sakamoto H, Tsukaguchi T, Hiroshima S, et al. CH5424802, a selective ALK inhibitor capable of blocking the resistant gatekeeper mutant. Cancer Cell. 2011;19:679-690.
Sakamoto H, Tsukaguchi T, Hiroshima S, et al. CH5424802, a selective ALK inhibitor capable of blocking the resistant gatekeeper mutant. Cancer Cell. 2011;19:679-690.
Kodama T, Hasegawa M, Takanashi K, Sakurai Y, Kondoh O, Sakamoto H. Antitumor activity of the selective ALK inhibitor alectinib in models of intracranial metastases. Cancer Chemother Pharmacol. 2014;74:1023-1028.
Kodama T, Hasegawa M, Takanashi K, Sakurai Y, Kondoh O, Sakamoto H. Antitumor activity of the selective ALK inhibitor alectinib in models of intracranial metastases. Cancer Chemother Pharmacol. 2014;74:1023-1028.
Löscher W, Potschka H. Blood-brain barrier active efflux transporters: ATP-binding cassette gene family. NeuroRx. 2005;2:86-98.
Löscher W, Potschka H. Blood-brain barrier active efflux transporters: ATP-binding cassette gene family. NeuroRx. 2005;2:86-98.
Schinkel AH, Jonker JW. Mammalian drug efflux transporters of the ATP binding cassette (ABC) family: an overview. Adv Drug Deliv Rev. 2003;55:3-29.
Schinkel AH, Jonker JW. Mammalian drug efflux transporters of the ATP binding cassette (ABC) family: an overview. Adv Drug Deliv Rev. 2003;55:3-29.
Bartels AL. Blood-brain barrier p-glycoprotein function in neurodegenerative disease. Curr Pharm Des. 2011;17:2771-2777.
Bartels AL. Blood-brain barrier p-glycoprotein function in neurodegenerative disease. Curr Pharm Des. 2011;17:2771-2777.
Camidge DR, Dziadziuszko R, Peters S, et al. Updated efficacy and safety data and impact of the EML4-ALK fusion variant on the efficacy of alectinib in untreated ALK-positive advanced non-small cell lung cancer in the global phase III ALEX study [published online March 19, 2019]. J Thorac Oncol. doi:10.1016/j.jtho.2019.03.007.
Camidge DR, Dziadziuszko R, Peters S, et al. Updated efficacy and safety data and impact of the EML4-ALK fusion variant on the efficacy of alectinib in untreated ALK-positive advanced non-small cell lung cancer in the global phase III ALEX study [published online March 19, 2019]. J Thorac Oncol. doi:10.1016/j.jtho.2019.03.007.
Peters S, Camidge DR, Shaw AT, et al. Alectinib versus crizotinib in untreated ALK-positive non–small cell lung cancer. N Engl J Med. 2017;377(protocol):1-384.
Peters S, Camidge DR, Shaw AT, et al. Alectinib versus crizotinib in untreated ALK-positive non–small cell lung cancer. N Engl J Med. 2017;377(protocol):1-384.
Gadgeel, S. Alectinib vs crizotinib in treatment-naïve ALK+ NSCLC: CNS efficacy results from the ALEX study. Oral presentation at: European Society for Medical Oncology Congress; September, 2017; Madrid, Spain.
Gadgeel, S. Alectinib vs crizotinib in treatment-naïve ALK+ NSCLC: CNS efficacy results from the ALEX study. Oral presentation at: European Society for Medical Oncology Congress; September, 2017; Madrid, Spain.
Peters S, Camidge DR, Shaw AT, et al. Alectinib versus crizotinib in untreated ALK-positive non-small-cell lung cancer. N Engl J Med. 2017;377(suppl):1-14.
Peters S, Camidge DR, Shaw AT, et al. Alectinib versus crizotinib in untreated ALK-positive non-small-cell lung cancer. N Engl J Med. 2017;377(suppl):1-14.
Camidge DR, Peters S, Mok T, et al. Updated efficacy and safety data from the global phase III ALEX study of alectinib (ALC) vs crizotinib (CZ) in untreated advanced ALK+ NSCLC. Abstract no. 9043. Presented at: 2018 American Society of Clinical Oncology Annual Meeting; June 1-5, 2018; Chicago, IL.
Camidge DR, Peters S, Mok T, et al. Updated efficacy and safety data from the global phase III ALEX study of alectinib (ALC) vs crizotinib (CZ) in untreated advanced ALK+ NSCLC. Abstract no. 9043. Presented at: 2018 American Society of Clinical Oncology Annual Meeting; June 1-5, 2018; Chicago, IL.
Mok T, Camidge DR, Gadgeel SM, et al. Updated overall survival and final progression-free survival data for patients with treatment-naive advanced ALK-positive non-small-cell lung cancer in the ALEX study. Ann Oncol. 2020;31(8):1056-1064.
Mok T, Camidge DR, Gadgeel SM, et al. Updated overall survival and final progression-free survival data for patients with treatment-naive advanced ALK-positive non-small-cell lung cancer in the ALEX study. Ann Oncol. 2020;31(8):1056-1064.
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