Current Insights on the Treatment of Anaplastic Lymphoma Kinase-Positive Metastatic Non-Small Cell Lung Cancer: Focus on Brigatinib

References

• Sung H, Ferlay J, Siegel RL, et al. Global cancer statistics 2020: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2021;71(3):209–249. doi:10.3322/caac.21660
   PubMed Web of Science ®Google Scholar
• Soda M, Choi YL, Enomoto M, et al. Identification of the transforming EML4-ALK fusion gene in non-small-cell lung cancer. Nature. 2007;448(7153):561–566. doi:10.1038/nature05945
   PubMed Web of Science ®Google Scholar
• McKeage MJ, Tin Tin S, Khwaounjoo P, et al. Screening for anaplastic lymphoma kinase (ALK) gene rearrangements in non-small-cell lung cancer in New Zealand. Intern Med J. 2020;50(6):716–725. doi:10.1111/imj.14435
   PubMed Web of Science ®Google Scholar
• Colombino M, Paliogiannis P, Cossu A, et al. EGFR, KRAS, BRAF, ALK, and cMET genetic alterations in 1440 Sardinian patients with lung adenocarcinoma. BMC Pulm Med. 2019;19(1):209. doi:10.1186/s12890-019-0964-x
   PubMed Web of Science ®Google Scholar
• Shaw AT, Yeap BY, 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):4247–4253. doi:10.1200/JCO.2009.22.6993
   PubMed Web of Science ®Google Scholar
• Schrank Z, Chhabra G, Lin L, et al. Current molecular-targeted therapies in NSCLC and their mechanism of resistance. Cancers. 2018;10(7):224. doi:10.3390/cancers10070224
   PubMed Web of Science ®Google Scholar
• Kazandjian D, Blumenthal GM, Chen HY, et al. FDA approval summary: crizotinib for the treatment of metastatic non-small cell lung cancer with anaplastic lymphoma kinase rearrangements. Oncologist. 2014;19(10):e5–e11. doi:10.1634/theoncologist.2014-0241
   PubMed Web of Science ®Google Scholar
• Huang WS, Liu S, Zou D, et al. Discovery of brigatinib (AP26113), a phosphine oxide-containing, potent, orally active inhibitor of anaplastic lymphoma kinase. J Med Chem. 2016;59(10):4948–4964. doi:10.1021/acs.jmedchem.6b00306
   PubMed Web of Science ®Google Scholar
• Tugnait M, Gupta N, Hanley MJ, et al. Effects of strong CYP2C8 or CYP3A inhibition and CYP3A induction on the pharmacokinetics of brigatinib, an oral anaplastic lymphoma kinase inhibitor, in healthy volunteers. Clin Pharmacol Drug Dev. 2020;9(2):214–223. doi:10.1002/cpdd.723
   PubMed Web of Science ®Google Scholar
• Tugnait M, Gupta N, Hanley MJ, et al. The effect of a high-fat meal on the pharmacokinetics of brigatinib, an oral anaplastic lymphoma kinase inhibitor, in healthy volunteers. Clin Pharmacol Drug Dev. 2019;8(6):734–741. doi:10.1002/cpdd.641
   PubMed Web of Science ®Google Scholar
• Zhang S, Anjum R, Squillace R, et al. The potent ALK inhibitor brigatinib (AP26113) overcomes mechanisms of resistance to first- and second-generation ALK inhibitors in preclinical models. Clin Cancer Res. 2016;22(22):5527–5538. doi:10.1158/1078-0432.CCR-16-0569
   PubMed Web of Science ®Google Scholar
• Horn L, Whisenant JG, Wakelee H, et al. Monitoring therapeutic response and resistance: analysis of circulating tumor DNA in patients with ALK+ lung cancer. J Thorac Oncol. 2019;14(11):1901–1911. doi:10.1016/j.jtho.2019.08.003
   PubMed Web of Science ®Google Scholar
• Gettinger SN, Bazhenova LA, Langer CJ, et al. Activity and safety of brigatinib in ALK-rearranged non-small-cell lung cancer and other malignancies: a single-arm, open-label, phase 1/2 trial. Lancet Oncol. 2016;17(12):1683–1696. doi:10.1016/S1470-2045(16)30392-8
   PubMed Web of Science ®Google Scholar
• Kim DW, Tiseo M, Ahn MJ, et al. Brigatinib in patients with crizotinib-refractory anaplastic lymphoma kinase-positive non-small-cell lung cancer: a randomized, multicenter phase II trial. J Clin Oncol. 2017;35(22):2490–2498. doi:10.1200/JCO.2016.71.5904
   PubMed Web of Science ®Google Scholar
• U.S. Food & Drug Administration. Brigatinib; [updated July 25, 2017]. Available from: https://www.fda.gov/drugs/resources-information-approved-drugs/brigatinib. Accessed November 20, 2021.
   Google Scholar
• Camidge DR, Kim DW, Tiseo M, et al. Exploratory analysis of brigatinib activity in patients with anaplastic lymphoma kinase-positive non-small-cell lung cancer and brain metastases in two clinical trials. J Clin Oncol. 2018;36(26):2693–2701. doi:10.1200/JCO.2017.77.5841
   PubMed Web of Science ®Google Scholar
• Huber RM, Hansen KH, Paz-Ares Rodríguez L, et al. Brigatinib in crizotinib-refractory ALK+ NSCLC: 2-year follow-up on systemic and intracranial outcomes in the phase 2 ALTA trial. J Thorac Oncol. 2020;15(3):404–415. doi:10.1016/j.jtho.2019.11.004
   PubMed Web of Science ®Google Scholar
• 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;37(16):1370–1379. doi:10.1200/JCO.18.02236
   PubMed Web of Science ®Google Scholar
• Shaw AT, Kim TM, Crinò 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):874–886. doi:10.1016/S1470-2045(17)30339-X
   PubMed Web of Science ®Google Scholar
• Shaw AT, Gandhi L, Gadgeel S, et al. Alectinib in ALK-positive, crizotinib-resistant, non-small-cell lung cancer: a single-group, multicentre, phase 2 trial. Lancet Oncol. 2016;17(2):234–242. doi:10.1016/S1470-2045(15)00488-X
   PubMed Web of Science ®Google Scholar
• Lenderking WR, Lin H, Speck RM, et al. Patient-reported outcomes and quality of life in advanced ALK+ non-small-cell lung cancer trial of brigatinib (ALTA). Future Oncol. 2019;15(24):2841–2855. doi:10.2217/fon-2019-0185
   PubMed Web of Science ®Google Scholar
• Kawata AK, Lenderking WR, Eseyin OR, et al. Converting EORTC QLQ-C30 scores to utility scores in the brigatinib ALTA study. J Med Econ. 2019;22(9):924–935. doi:10.1080/13696998.2019.1624080
   PubMed Web of Science ®Google Scholar
• Gettinger SN, Huber RM, Kim DW, et al. Brigatinib in ALK+ crizotinib-refractory non–small cell lung cancer: final results of the phase 1/2 and phase 2 (ALTA) trials. Presented at the 2021 ASCO Annual Meeting; June 4–8;Virtual Abstract 9071; 2021.
   Google Scholar
• Camidge DR, Kim HR, Ahn MJ, et al. Brigatinib versus crizotinib in ALK-positive non-small-cell lung cancer. N Engl J Med. 2018;379(21):2027–2039. doi:10.1056/NEJMoa1810171
   PubMed Web of Science ®Google Scholar
• Camidge DR, Niu H, Kim HR, et al. Correlation of baseline molecular and clinical variables with ALK inhibitor efficacy in ALTA-1L. J Clin Oncol. 2020;38(15):9517. doi:10.1200/JCO.2020.38.15_suppl.9517
   Web of Science ®Google Scholar
• Christopoulos P, Kirchner M, Endris V, Stenzinger A, Thomas M. EML4-ALK V3, treatment resistance, and survival: refining the diagnosis of ALK+ NSCLC. J Thorac Dis. 2018;10(17):S1989–S1991. doi:10.21037/jtd.2018.05.61
   PubMed Web of Science ®Google Scholar
• Kron A, Alidousty C, Scheffler M, et al. Impact of TP53 mutation status on systemic treatment outcome in ALK-rearranged non-small-cell lung cancer. Ann Oncol. 2018;29(10):2068–2075. doi:10.1093/annonc/mdy333
   PubMed Web of Science ®Google Scholar
• Christopoulos P, Kirchner M, Bozorgmehr F, et al. Identification of a highly lethal V3+ TP53+ subset in ALK+ lung adenocarcinoma. Int J Cancer. 2019;144(1):190–199. doi:10.1002/ijc.31893
   PubMed Web of Science ®Google Scholar
• Camidge DR, Kim HR, Ahn MJ, et al. Brigatinib versus crizotinib in advanced ALK inhibitor-naive ALK-positive non-small cell lung cancer: second interim analysis of the phase III ALTA-1L trial. J Clin Oncol. 2020;38(31):3592–3603. doi:10.1200/JCO.20.00505
   PubMed Web of Science ®Google Scholar
• Garcia Campelo MR, Lin HM, Zhu Y, et al. Health-related quality of life in the randomized phase III trial of brigatinib vs crizotinib in advanced ALK inhibitor-naive ALK + non-small cell lung cancer (ALTA-1L). Lung Cancer. 2021;155:68–77. doi:10.1016/j.lungcan.2021.03.005
   PubMed Web of Science ®Google Scholar
• U.S. Food & Drug Administration. FDA approves brigatinib for ALK-positive metastatic NSCLC; [updated May 26, 2020]. Available from: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-brigatinib-alk-positive-metastatic-nsclc. Accessed November 20, 2021.
   Google Scholar
• Camidge DR, Kim HR, Ahn MJ, et al. Brigatinib versus crizotinib in ALK inhibitor-naive advanced ALK-positive NSCLC: final results of phase 3 ALTA-1L trial. J Thorac Oncol. 2021;16(12):2091–2108. doi:10.1016/j.jtho.2021.07.035
   PubMed Web of Science ®Google Scholar
• Nishio M, Yoshida T, Kumagai T, et al. Brigatinib in Japanese patients with ALK-positive NSCLC previously treated with alectinib and other tyrosine kinase inhibitors: outcomes of the phase 2 J-ALTA trial. J Thorac Oncol. 2021;16(3):452–463. doi:10.1016/j.jtho.2020.11.004
   PubMed Web of Science ®Google Scholar
• Kondo M, Sugawara S, Yokoyama T, et al. Brigatinib in Japanese patients with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC): first results from the J-ALTA tyrosine kinase inhibitor (TKI)-naive expansion cohort. Presented at the 2021 ASCO Annual Meeting; June 4–8;Virtual Abstract 9042; 2021.
   Google Scholar
• Kim ES, Barlesi F, Mok T, et al. ALTA-2: phase II study of brigatinib in patients with ALK-positive, advanced non-small-cell lung cancer who progressed on alectinib or ceritinib. Future Oncol. 2021;17(14):1709–1719. doi:10.2217/fon-2020-1119
   PubMed Web of Science ®Google Scholar
• Christopoulos P, Bozorgmehr F, Brückner L, et al. Brigatinib versus other second-generation ALK inhibitors as initial treatment of anaplastic lymphoma kinase positive non-small cell lung cancer with deep phenotyping: study protocol of the ABP trial. BMC Cancer. 2021;21(1):743. doi:10.1186/s12885-021-08460-w
   PubMed Web of Science ®Google Scholar
• Popat S, Liu G, Lu S, Song G, Ma X, Yang JC. Brigatinib vs alectinib in crizotinib-resistant advanced anaplastic lymphoma kinase-positive non-small-cell lung cancer (ALTA-3). Future Oncol. 2021;17(32):4237–4247. doi:10.2217/fon-2021-0608
   PubMed Web of Science ®Google Scholar
• Stinchcombe TE, Doebele RC, Wang X, Gerber DE, Horn L, Camidge DR. Preliminary clinical and molecular analysis results from a single-arm phase 2 trial of brigatinib in patients with disease progression after next-generation ALK tyrosine kinase inhibitors in advanced ALK+ NSCLC. J Thorac Oncol. 2021;16(1):156–161. doi:10.1016/j.jtho.2020.09.018
   PubMed Web of Science ®Google Scholar
• ClinicalTrials.gov. Brigatinib in ALK-positive NSCLC identified via blood-based assays; [updated September 10, 2020]. Available from: https://clinicaltrials.gov/ct2/show/NCT04074993?term=nsclc&cond=brigatinib&phase=123&draw=2&rank=4. Accessed November 20, 2021.
   Google Scholar
• ClinicalTrials.gov. Clinical utility of liquid biopsy in brigatinib ALK+ patients (CUBIK); [updated August 11, 2021]. Available from: https://clinicaltrials.gov/ct2/show/NCT04223596?term=nsclc&cond=brigatinib&phase=123&draw=2&rank=10. Accessed November 20, 2021.
   Google Scholar
• ClinicalTrials.gov. Brigatinib before brain irradiation trial (B3i Trial); [updated March 22, 2021]. Available from: https://clinicaltrials.gov/ct2/show/NCT04634110?term=nsclc&cond=brigatinib&phase=123&draw=2&rank=9. Accessed November 20, 2021.
   Google Scholar
• Horn L, Wang Z, Wu G, et al. Ensartinib vs crizotinib for patients with anaplastic lymphoma kinase−positive non–small cell lung cancer: a randomized clinical trial. JAMA Oncol. 2021;7(11):1617–1625. doi:10.1001/jamaoncol.2021.3523
   PubMed Web of Science ®Google Scholar
• Ando K, Manabe R, Kishino Y, et al. Comparative efficacy and safety of lorlatinib and alectinib for ALK-rearrangement positive advanced non-small cell lung cancer in Asian and non-Asian patients: a systematic review and network meta-analysis. Cancers. 2021;13(15):3704. doi:10.3390/cancers13153704
   PubMed Web of Science ®Google Scholar
• 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;19(12):1654–1667. doi:10.1016/S1470-2045(18)30649-1
   PubMed Web of Science ®Google Scholar
• Descourt R, Pérol M, Rousseau-Bussac G, et al. BrigALK2 study: a multicentric real-world study evaluating brigatinib in ALK positive advanced pre-treated non-small cell lung cancers: long-term follow-up with focus on lorlatinib efficacy after brigatinib. Presented at the 2021 ASCO Annual Meeting; June 4 –8;Virtual Abstract 1200P; 2021.
   Google Scholar