Ceritinib in the treatment of ALK-positive non-small cell lung cancer

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The range of anticancer drugs for the treatment of non-small cell lung cancer has changed significantly in recent years due to the advent of immunotherapy and targeted drugs targeting driver mutations. Today it has become possible to prescribe more effective and less toxic treatment to patients than chemotherapy. This review focuses on the ceritinib, 2nd generation ALK inhibitor. Data from clinical studies confirming the effectiveness of the drug and the feasibility of its use both in pre-treated patients and in patients with newly diagnosed metastatic ALK-positive non-small cell lung cancer are presented.

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作者简介

O. Gordeeva

Lopukhin Federal Research and Clinical Center for Physical-Chemical Medicine, FMBA of Russia

编辑信件的主要联系方式.
Email: gordeeva.oo@yandex.ru
ORCID iD: 0000-0002-8266-0218
俄罗斯联邦, Moscow

K. Ivanova

Lopukhin Federal Research and Clinical Center for Physical-Chemical Medicine, FMBA of Russia

Email: gordeeva.oo@yandex.ru
ORCID iD: 0000-0001-7087-2435
俄罗斯联邦, Moscow

A. Meshcheryakov

Lopukhin Federal Research and Clinical Center for Physical-Chemical Medicine, FMBA of Russia

Email: gordeeva.oo@yandex.ru
ORCID iD: 0000-0002-6009-653X
俄罗斯联邦, Moscow

参考

  1. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines ®). Non-Small Cell Lung Cancer. Version 3.2023 – April 13, 2023.
  2. Hendriks L.E., Kerr K.M., Menis J., et al; Oncogene-addicted metastatic non-small-cell lung cancer: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up. Ann Oncol. 2023;34(4):339–57.
  3. Министерство Здравоохранения РФ. Клинические рекомендации «Злокачественное новообразование бронхов и легкого». Год утверждения: 2022. [Ministry of Health of the Russian Federation. Clinical recommendations “Malignant neoplasm of the bronchi and lung.” Year of approval: 2022. (In Russ.)].
  4. Soda M., Choi Y.L., Enomoto M., et al. Identification of the transforming EML4-ALK fusion gene in non-small-cell lung cancer. Nature. 2007;448(7153):561–66.
  5. Tsao M.S., Hirsch F.R., Yatabe Y. IASLC atlas of ALK testing in lung cancer, 2013.
  6. Shaw A.T., Yeap B.Y., Mino-Kenudson M., et al. Clinical Features and Outcome of Patients With Non–Small-Cell Lung Cancer Who Harbor EML4-ALK. J Clin Oncol. 2009;27(26):4247–53.
  7. Demidova I., Grinevich V., Avdalian A., et al. Detection of ALK rearrangements in 4002 Russian patients: The utility of different diagnostic approaches. Lung Cancer. 2017;103:17–23. doi: 10.1016/j.lungcan.2016.11.001.
  8. Solomon B.J., et al. First-Line Crizotinib versus Chemotherapy in ALK-Positive Lung Cancer. N Engl J Med. 2014;371:2167–77.
  9. Friboulet L., Li N., Katayama R., Lee C.C., et al. The ALK inhibitor ceritinib overcomes crizotinib resistance in non-small cell lung cancer. Cancer Discov. 2014;4(6):662–73. doi: 10.1158/2159-8290.CD-13-0846.
  10. Novartis. Zykadia prescribing information. Basel: Novartis, 2014.
  11. Shaw A.T., Kim D.W., Mehra R., et al. Ceritinib in ALK-rearranged non-small-cell lung cancer. N Engl J Med. 2014;370(13):1189–97. doi: 10.1056/NEJMoa1311107.
  12. Khozin S., Blumenthal G.M., Zhang L., et al. FDA Approval: Ceritinib for the Treatment of Metastatic Anaplastic Lymphoma Kinase-Positive Non-Small Cell Lung Cancer. Clin Cancer Res. 2015;21(11):2436–39.
  13. Kim D.W., Mehra R., Tan D.S.W., et al. Activity and safety of ceritinib in patients with ALK-rearranged non-small-cell lung cancer (ASCEND-1): updated results from the multicentre, open-label, phase 1 trial. Lancet. Oncol. 2016;17(4):452–63. doi: 10.1016/S1470-2045(15)00614-2.
  14. Wu Y.L., Shi Y., Tan D.S.W., et al. Phase 1/2 study of ceritinib in Chinese patients with advanced anaplastic lymphoma kinase-rearranged non-small cell lung cancer previously treated with crizotinib: Results from ASCEND-6. Lung Cancer. 2020;150:240–46. doi: 10.1016/j.lungcan.2020.10.024.
  15. Crino L., Ahn M.J., De Marinis F., et al. Multicenter Phase II Study of Whole-Body and Intracranial Activity With Ceritinib in Patients With ALK-Rearranged Non-Small-Cell Lung Cancer Previously Treated With Chemotherapy and Crizotinib: Results From ASCEND-2. J Clin Oncol. 2016;34(24):2866–73. doi: 10.1200/JCO.2015.65.5936.
  16. Nishio M., Felip E., Orlov S., et al. Final Overall Survival and Other Efficacy and Safety Results From ASCEND-3: Phase II Study of Ceritinib in ALKi-Naive Patients With ALK-Rearranged NSCLC. J Thorac Oncol. 2020;15(4):609–17. doi: 10.1016/j.jtho.2019.11.006.
  17. Shaw A.T., Kim T.M., Crino L., et al. Ceritinib versus chemotherapy in patients with ALK-rearranged non-small-cell lung cancer previously given chemotherapy and crizotinib (ASCEND-5): a randomised, controlled, open-label, phase 3 trial. Lancet. Oncol. 2017;18(7):874–86. doi: 10.1016/S1470-2045(17)30339-X. [Epub 2017 Jun 9].
  18. Chow L.Q.M., Barlesi F., Bertino E.M., et al. ASCEND-7: Efficacy and Safety of Ceritinib Treatment in Patients with ALK-Positive Non-Small Cell Lung Cancer Metastatic to the Brain and/or Leptomeninges. Clin Cancer Res. 2022;28(12):2506–16. doi: 10.1158/1078-0432.CCR-21-1838.
  19. Soria J.C., Tan D.S.W., Chiari R., et al. 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. 2017;389(10072):917–29. doi: 10.1016/S0140-6736(17)30123-X. [Epub 2017 Jan 24. Erratum in: Lancet. 2017 Mar 4;389(10072):908].
  20. Abbas R., Hug B.A., Leister C., et al. A phase I ascending single-dose study of the safety, tolerability, and pharmacokinetics of bosutinib (SKI-606) in healthy adult subjects. Cancer Chemother Pharmacol. 2012;69(1):221–27. doi: 10.1007/s00280-011-1688-7.
  21. Lau Y.Y., Gu W., Lin T., et al. Effects of meal type on the oral bioavailability of the ALK inhibitor ceritinib in healthy adult subjects. J Clin Pharmacol. 2016;56(5):559–66. doi: 10.1002/jcph.619.
  22. Cho B.C., Kim D.W., Bearz A., et al. ASCEND-8: A Randomized Phase 1 Study of Ceritinib, 450 mg or 600 mg, Taken with a Low-Fat Meal versus 750 mg in Fasted State in Patients with Anaplastic Lymphoma Kinase (ALK)-Rearranged Metastatic Non-Small Cell Lung Cancer (NSCLC). J Thorac Oncol. 2017;12(9):1357–67. doi: 10.1016/j.jtho.2017.07.005.
  23. Cho B.C., Obermannova R., Bearz A., et al. Efficacy and Safety of Ceritinib (450 mg/d or 600 mg/d) With Food Versus 750-mg/d Fasted in Patients With ALK Receptor Tyrosine Kinase (ALK)-Positive NSCLC: Primary Efficacy Results From the ASCEND-8 Study. J Thorac Oncol. 2019;14(7):1255–65. doi: 10.1016/j.jtho.2019.03.002. [Epub 2019 Mar 7].
  24. Инструкция по медицинскому применению препарата Зикадия® ЛП-004766 от 24.12.2018. [Instructions for medical use of the drug Zykadia® LP-004766 dated December 24, 2018. (In Russ.)].

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1. JATS XML
2. Figure. PFS as independently assessed in the ASCEND-4 trial

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