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Drug Profile

Lorlatinib for the treatment of ALK-positive metastatic non-small cell lung cancer

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Pages 233-240 | Received 19 Dec 2019, Accepted 27 Feb 2020, Published online: 25 Mar 2020

References

  • Soda M, Choi YL, Enomoto M, et al. Identification of the transforming EML4-ALK fusion gene in non-small-cell lung cancer. Nature. 2007 Aug 2;448(7153):561–566. PubMed PMID: 17625570; eng.
  • Perner S, Wagner PL, Demichelis F, et al. EML4-ALK fusion lung cancer: a rare acquired event. Neoplasia (New York, NY). 2008 Mar;10(3):298–302. PubMed PMID: 18320074; PubMed Central PMCID: PMCPMC2259458. eng.
  • Choi YL, Takeuchi K, Soda M, et al. Identification of novel isoforms of the EML4-ALK transforming gene in non-small cell lung cancer. Cancer Res. 2008 Jul 1;68(13):4971–4976. PubMed PMID: 18593892; eng.
  • Kwak EL, Bang Y-J, Camidge DR, et al. Anaplastic lymphoma kinase inhibition in non–small-cell lung cancer. N Engl J Med. 2010;363(18):1693–1703. PubMed PMID: 20979469.
  • Shaw AT, Kim D-W, Nakagawa K, et al. Crizotinib versus chemotherapy in advanced ALK-positive lung cancer. N Engl J Med. 2013;368(25):2385–2394. PubMed PMID: 23724913.
  • Solomon BJ, Mok T, Kim D-W, et al. First-line crizotinib versus chemotherapy in ALK-positive lung cancer. N Engl J Med. 2014;371(23):2167–2177. PubMed PMID: 25470694.
  • Costa DB, Shaw AT, Ou SH, et al. Clinical experience with crizotinib in patients with advanced ALK-rearranged non-small-cell lung cancer and brain metastases. J Clin Oncol. 2015 Jun 10;33(17):1881–1888. PubMed PMID: 25624436; PubMed Central PMCID: PMCPMC4451171. eng.
  • 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 Aug 31;377(9):829–838. PubMed PMID: 28586279; eng.
  • Hida T, Nokihara H, Kondo M, et al. Alectinib versus crizotinib in patients with ALK-positive non-small-cell lung cancer (J-ALEX): an open-label, randomised phase 3 trial. Lancet. 2017;390(10089):29–39.
  • Soria J-C, Tan DSW, 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):917–929.
  • Gainor JF, Dardaei L, Yoda S, et al. Molecular mechanisms of resistance to first- and second-generation ALK inhibitors in ALK-rearranged lung cancer. Cancer Discov. 2016 Oct;6(10):1118–1133. PubMed PMID: 27432227; PubMed Central PMCID: PMCPMC5050111. eng.
  • Doebele RC, Pilling AB, Aisner DL, et al. Mechanisms of resistance to crizotinib in patients with ALK gene rearranged non-small cell lung cancer. Clin Cancer Res off J Am Assoc Cancer Res. 2012 Mar 1;18(5):1472–1482. Ccr-11-2906. PubMed PMID: 22235099; PubMed Central PMCID: PMCPMC3311875. eng.
  • Katayama R, Shaw AT, Khan TM, et al. Mechanisms of acquired crizotinib resistance in ALK-rearranged lung cancers. Sci Transl Med. 2012 Feb 8;4(120):120ra17. PubMed PMID: 22277784; PubMed Central PMCID: PMCPMC3385512. eng.
  • Yu HA, Arcila ME, Rekhtman N, et al. Analysis of tumor specimens at the time of acquired resistance to EGFR-TKI therapy in 155 patients with EGFR-mutant lung cancers. Clin Cancer Res off J Am Assoc Cancer Res. 2013 Apr 15;19(8):2240–2247. ccr-12-2246. PubMed PMID: 23470965; PubMed Central PMCID: PMCPMC3630270. eng.
  • Choi YL, Soda M, Yamashita Y, et al. EML4-ALK mutations in lung cancer that confer resistance to ALK inhibitors. N Engl J Med. 2010 Oct 28;363(18):1734–1739. PubMed PMID: 20979473; eng.
  • Toyokawa G, Hirai F, Inamasu E, et al. Secondary mutations at I1171 in the ALK gene confer resistance to both crizotinib and alectinib. J Thorac Oncol. 2014 Dec;9(12):e86–7. PubMed PMID: 25393798; eng.
  • Sasaki T, Koivunen J, Ogino A, et al. A novel ALK secondary mutation and EGFR signaling cause resistance to ALK kinase inhibitors. Cancer Res. 2011 Sep 15;71(18):6051–6060. PubMed PMID: 21791641; PubMed Central PMCID: PMCPMC3278914. eng.
  • Friboulet L, Li N, Katayama R, et al. The ALK inhibitor ceritinib overcomes crizotinib resistance in non-small cell lung cancer. Cancer Discov. 2014 Jun;4(6):662–673. PubMed PMID: 24675041; PubMed Central PMCID: PMCPMC4068971. eng.
  • Sakamoto H, Tsukaguchi T, Hiroshima S, et al. CH5424802, a selective ALK inhibitor capable of blocking the resistant gatekeeper mutant. Cancer Cell. 2011 May 17;19(5):679–690. PubMed PMID: 21575866; eng.
  • Zou HY, Friboulet L, Kodack DP, et al. PF-06463922, an ALK/ROS1 inhibitor, overcomes resistance to first and second generation ALK inhibitors in preclinical models. Cancer Cell. 2015 Jul 13;28(1):70–81. PubMed PMID: 26144315; PubMed Central PMCID: PMCPMC4504786. eng.
  • Lovly CM, McDonald NT, Chen H, et al. Rationale for co-targeting IGF-1R and ALK in ALK fusion-positive lung cancer. Nat Med. 2014 Sep;20(9):1027–1034. PubMed PMID: 25173427; PubMed Central PMCID: PMCPMC4159407. eng.
  • Crystal AS, Shaw AT, Sequist LV, et al. Patient-derived models of acquired resistance can identify effective drug combinations for cancer. Science (New York, NY). 2014 Dec 19;346(6216):1480–1486. PubMed PMID: 25394791; PubMed Central PMCID: PMCPMC4388482. eng.
  • Gouji T, Takashi S, Mitsuhiro T, et al. Crizotinib can overcome acquired resistance to CH5424802: is amplification of the MET gene a key factor? J Thorac Oncol. 2014;9(3):e27–e28.
  • Yun MR, Choi HM, Lee YW, et al. Targeting YAP to overcome acquired resistance to ALK inhibitors in ALK-rearranged lung cancer. EMBO Mol Med. 2019 Oct 21:e10581. PubMed PMID: 31633304; eng. DOI: 10.15252/emmm.201910581
  • Cha YJ, Cho BC, Kim HR, et al. A case of ALK-rearranged adenocarcinoma with small cell carcinoma-like transformation and resistance to crizotinib. J Thorac Oncol. 2016;11(5):e55–e58. 2016/05/01/.
  • Fujita S, Masago K, Katakami N, et al. Transformation to SCLC after treatment with the ALK inhibitor alectinib. J Thorac Oncol. 2016;11(6):e67–e72. 2016/06/01/.
  • Kobayashi Y, Sakao Y, Ito S, et al. Transformation to sarcomatoid carcinoma in ALK-rearranged adenocarcinoma, which developed acquired resistance to crizotinib and received subsequent chemotherapies. J Thorac Oncol. 2013 Aug;8(8):e75–8. PubMed PMID: 23857406; eng.
  • Kim HR, Kim WS, Choi YJ, et al. Epithelial-mesenchymal transition leads to crizotinib resistance in H2228 lung cancer cells with EML4-ALK translocation. Mol Oncol. 2013 Dec;7(6):1093–1102. PubMed PMID: 23993685; PubMed Central PMCID: PMCPMC5528442. eng.
  • Johnson TW, Richardson PF, Bailey S, et al. Discovery of (10R)-7-amino-12-fluoro-2,10,16-trimethyl-15-oxo-10,15,16,17-tetrahydro-2H-8,4-(m etheno)pyrazolo[4,3-h][2,5,11]-benzoxadiazacyclotetradecine-3-carbonitrile (PF-06463922), a macrocyclic inhibitor of anaplastic lymphoma kinase (ALK) and c-ros oncogene 1 (ROS1) with preclinical brain exposure and broad-spectrum potency against ALK-resistant mutations. J Med Chem. 2014 Jun 12;57(11):4720–4744. PubMed PMID: 24819116; eng.
  • Kim S, Kim TM, Kim DW, et al. Heterogeneity of genetic changes associated with acquired crizotinib resistance in ALK-rearranged lung cancer. J Thorac Oncol. 2013 Apr;8(4):415–422. PubMed PMID: 23344087; eng.
  • Collier TL, Normandin MD, Stephenson NA, et al. Synthesis and preliminary PET imaging of (11)C and (18)F isotopologues of the ROS1/ALK inhibitor lorlatinib. Nat Commun. 2017 Jun 8;8(1):15761. PubMed PMID: 28594000; PubMed Central PMCID: PMCPMC5472746. eng.
  • Shaw AT, Felip E, Bauer TM, et al. Lorlatinib in non-small-cell lung cancer with ALK or ROS1 rearrangement: an international, multicentre, open-label, single-arm first-in-man phase 1 trial. Lancet Oncol. 2017 Dec;18(12):1590–1599. PubMed PMID: 29074098; PubMed Central PMCID: PMCPMC5777233. eng.
  • Felip E, Solomon BJ, Besse B, et al. 1542PSafety of lorlatinib in subgroups of patients from a phase I/II trial. Ann Oncol. 2019;30(Supplement_5):v633-v634.
  • FDA. Full prescribing information for lorlatinib 2018 [cited 2019 Sept 15]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210868s000lbl.pdf
  • Chen J, Bearz A, Kim D, et al. P1.01-84 interaction of lorlatinib with CYP2B6, CYP2C9, UGT, and P-gp probe drugs in patients with advanced non-small cell lung cancer. J Thorac Oncol. 2019;14(10):S392–S393.
  • Solomon BJ, Besse B, Bauer TM, et al. Lorlatinib in patients with ALK-positive non-small-cell lung cancer: results from a global phase 2 study. Lancet Oncol. 2018 Dec;19(12):1654–1667. PubMed PMID: 30413378; eng.
  • Recondo G, Mezquita L, Facchinetti F, et al. Diverse resistance mechanisms to the third-generation ALK inhibitor lorlatinib in ALK-rearranged lung cancer. Clin Cancer Res off J Am Assoc Cancer Res. 2019 Oct 4 PubMed PMID: 31585938; eng. DOI:10.1158/1078-0432.Ccr-19-1104
  • Yoda S, Lin JJ, Lawrence MS, et al. Sequential ALK inhibitors can select for lorlatinib-resistant compound ALK mutations in ALK-positive lung cancer. Cancer Discov. 2018 Jun;8(6):714–729. PubMed PMID: 29650534; PubMed Central PMCID: PMCPMC5984716. eng.
  • Redaelli S, Ceccon M, Zappa M, et al. Lorlatinib treatment elicits multiple on- and off-target mechanisms of resistance in ALK-driven cancer. Cancer Res. 2018;78(24):6866–6880.
  • Sakakibara-Konishi J, Kitai H, Ikezawa Y, et al. Response to crizotinib re-administration after progression on lorlatinib in a patient with ALK-rearranged non–small-cell lung cancer. Clin Lung Cancer. 2019;20(5):e555–e559.
  • Coleman N, Wotherspoon A, Yousaf N, et al. Transformation to neuroendocrine carcinoma as a resistance mechanism to lorlatinib. Lung Cancer. 2019 Aug;134:117–120. PubMed PMID: 31319969; eng.
  • Shaw AT, Solomon BJ, Chiari R, et al. Lorlatinib in advanced ROS1-positive non-small-cell lung cancer: a multicentre, open-label, single-arm, phase 1–2 trial. Lancet Oncol. DOI:10.1016/S1470-2045(19)30655-2
  • RCP. (Royal College of Physicians). National lung cancer audit annual report 2016 (for the audit period 2015). 2016. [cited 2017 Aug 11. Available from: https://www.rcplondon.ac.uk/projects/outputs/nlca-annual-report-2016
  • Dagogo-Jack I, Brannon AR, Ferris LA, et al. Tracking the evolution of resistance to ALK tyrosine kinase inhibitors through longitudinal analysis of circulating tumor DNA. JCO Precis Oncol. 2018;2018. PubMed PMID: 29376144; PubMed Central PMCID: PMCPMC5785105. eng. DOI:10.1200/po.17.00160
  • Shaw AT, Solomon BJ, Besse B, et al. ALK resistance mutations and efficacy of lorlatinib in advanced anaplastic lymphoma kinase-positive non-small-cell lung cancer. J Clin Oncol. 2019 Jun 1;37(16):1370–1379. PubMed PMID: 30892989; PubMed Central PMCID: PMCPMC6544460. eng.
  • Planchard D, Popat S, Kerr K, et al. Metastatic non-small cell lung cancer: ESMO clinical practice guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2018 Oct 1;29(Suppl 4):iv192–iv237. PubMed PMID: 30285222; eng.
  • NCCN.NCCN clinical practice guidelines in oncology (NCCN guidelines). Non-Small Cell Lung Cancer. [ Version 1.2020 2019 [cited 2019 Dec 15]. Available from].. []. : https://www.nccn.org/professionals/physician_gls/pdf/nscl.pdf
  • Shaw AT, Friboulet L, Leshchiner I, et al. Resensitization to crizotinib by the lorlatinib ALK resistance mutation L1198F. N Engl J Med. 2015;374(1):54–61. PubMed PMID: 26698910.
  • Okada K, Araki M, Sakashita T, et al. Prediction of ALK mutations mediating ALK-TKIs resistance and drug re-purposing to overcome the resistance. EBioMedicine. 2019;41:105–119. PubMed PMID: 30662002; eng.

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