aThe exploratory follow-up, conducted 10 months later, was assessed by investigators, and no formal treatment comparisons were performed.4,15
bThis post-hoc OS analysis, conducted at ~5 years after randomization of the last patient, was exploratory in nature, and was not powered to show statistical significance.4,20
aThe exploratory follow-up, conducted 10 months later, was assessed by investigators, and no formal treatment comparisons were performed.4,15
bThis post-hoc OS analysis, conducted at ~5 years after randomization of the last patient, was exploratory in nature, and was not powered to show statistical significance.4,20
The efficacy and safety of ALECENSA were established in the head-to-head, global, open-label, Phase 3 ALEX trial that randomized 303 first-line patients with stage IIIB/IV ALK+ mNSCLC to receive ALECENSA 600 mg orally twice daily or crizotinib 250 mg orally twice daily. Treatment in both arms continued until disease progression or unacceptable toxicity. The primary efficacy endpoint was PFS as determined by Investigator (HR=0.48 [95% CI: 0.35, 0.66]; P<0.0001) based on RECIST v1.1. Additional efficacy endpoints included PFS (based on RECIST v1.1), ORR, DOR, and time to cause-specific CNS progression as determined by IRC. An additional secondary endpoint of ALEX was to evaluate and compare OS as determined by Investigator, and defined as the time from randomization to death from any cause.2,3
d When an ALK rearrangement is discovered prior to first-line systemic therapy.5
e NCCN makes no representations or warranties of any kind regarding their content, use, or application, and disclaims any responsibility for their application or use in any way.
1L=first-line; ALK=anaplastic lymphoma kinase; CI=confidence interval; CNS=central nervous system; DOR=duration of response; HR=hazard ratio; IRC=Independent Review Committee; mNSCLC=metastatic non-small cell lung cancer; mPFS=median progression-free survival; NCCN=National Comprehensive Cancer Network® (NCCN®); ORR=objective response rate; OS=overall survival; PFS=progression-free survival; RECIST=Response Evaluation Criteria in Solid Tumors.
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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.
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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.
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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.
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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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