From ASCEND-5 to ALUR to ALTA-3, an Anti-Climactic End to the Era of Randomized Phase 3 Trials of Next-Generation ALK TKIs in the Crizotinib-Refractory Setting

References

• Shaw AT, Kim DW, Nakagawa K, et al. Crizotinib versus chemotherapy in advanced ALK-positive lung cancer. N Engl J Med. 2013;368(25):2385–2394. doi:10.1056/NEJMoa1214886
   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):e5–11. doi:10.1634/theoncologist.2014-0241
   PubMed Web of Science ®Google Scholar
• Malik SM, Maher VE, Bijwaard KE, et al. U.S. Food and Drug Administration approval: crizotinib for treatment of advanced or metastatic non-small cell lung cancer that is anaplastic lymphoma kinase positive. Clin Cancer Res. 2014;20(8):2029–2034. doi:10.1158/1078-0432.CCR-13-3077
   PubMed Web of Science ®Google Scholar
• Solomon BJ, Mok T, Kim DW, et al. First-line crizotinib versus chemotherapy in ALK-positive lung cancer. N Engl J Med. 2014;371(23):2167–2177. doi:10.1056/NEJMoa1408440
   PubMed Web of Science ®Google Scholar
• Ou SI, Nagasaka M, Brazel D, et al. Will the clinical development of 4th-generation “double mutant active” ALK TKIs (TPX-0131 and NVL-655) change the future treatment paradigm of ALK+ NSCLC? Transl Oncol. 2021;14(11):101191. doi:10.1016/j.tranon.2021.101191
   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 randomized, 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
• Novello S, Mazières J, Oh IJ, et al. Alectinib versus chemotherapy in crizotinib-pretreated anaplastic lymphoma kinase (ALK)-positive non-small-cell lung cancer: results from the Phase III ALUR study. Ann Oncol. 2018;29(6):1409–1416. doi:10.1093/annonc/mdy121
   PubMed Web of Science ®Google Scholar
• Wolf J, Helland Å, Oh IJ, et al. Final efficacy and safety data, and exploratory molecular profiling from the phase III ALUR study of alectinib versus chemotherapy in crizotinib-pretreated ALK-positive non-small-cell lung cancer. ESMO Open. 2022;7(1):100333. doi:10.1016/j.esmoop.2021.100333
   PubMed Web of Science ®Google Scholar
• Popat S, Liu G, Lu S, et al. 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
• Yang JC, Liu G, Lu S, et al. ALTA-3: a randomized trial of brigatinib (BRG) vs alectinib (ALC) in crizotinib (CRZ)-refractory advanced ALK+ NSCLC. Ann Oncol. 2022;33(suppl_9):S1560–S1597. doi:10.1016/annonc/annonc1134
   Google Scholar
• Khozin S, Blumenthal GM, 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):2436–2439. doi:10.1158/1078-0432.CCR-14-3157
   PubMed Web of Science ®Google Scholar
• Ou SH, Ahn JS, De Petris L, et al. Alectinib in crizotinib-refractory ALK-rearranged non-small-cell lung cancer: a phase II global study. J Clin Oncol. 2016;34(7):661–668. doi:10.1200/JCO.2015.63.9443
   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
• 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
• Zhang SS, Nagasaka M, Zhu VW, et al. Going beneath the tip of the iceberg. Identifying and understanding EML4-ALK variants and TP53 mutations to optimize treatment of ALK fusion positive (ALK+) NSCLC. Lung Cancer. 2021;158:126–136. doi:10.1016/j.lungcan.2021.06.012
   PubMed Web of Science ®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
• 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(9):829–838. doi:10.1056/NEJMoa1704795
   PubMed Web of Science ®Google Scholar
• Nakagawa K, Hida T, Nokihara H, et al. Final progression-free survival results from the J-ALEX study of alectinib versus crizotinib in ALK-positive non-small-cell lung cancer. Lung Cancer. 2020;139:195–199. doi:10.1016/j.lungcan.2019.11.025
   PubMed Web of Science ®Google Scholar
• Zhou C, Kim SW, Reungwetwattana T, et al. Alectinib versus crizotinib in untreated Asian patients with anaplastic lymphoma kinase-positive non-small-cell lung cancer (ALESIA): a randomized phase 3 study. Lancet Respir Med. 2019;7(5):437–446. doi:10.1016/S2213-2600(19)30053-0
   PubMed Web of Science ®Google Scholar
• Shaw AT, Bauer TM, de Marinis F, et al. First-Line Lorlatinib or Crizotinib in Advanced ALK-Positive Lung Cancer. N Engl J Med. 2020;383(21):2018–2029. doi:10.1056/NEJMoa2027187
   PubMed Web of Science ®Google Scholar
• Ou SH, Jänne PA, Bartlett CH, et al. Clinical benefit of continuing ALK inhibition with crizotinib beyond initial disease progression in patients with advanced ALK-positive NSCLC. Ann Oncol. 2014;25(2):415–422. doi:10.1093/annonc/mdt572
   PubMed Web of Science ®Google Scholar
• Ng TL, Narasimhan N, Gupta N, et al. Early-onset pulmonary events associated with brigatinib use in advanced NSCLC. J Thorac Oncol. 2020;15(7):1190–1199. doi:10.1016/j.jtho.2020.02.011
   PubMed Web of Science ®Google Scholar
• Camidge DR, Kim HR, Ahn MJ, et al. Brigatinib versus crizotinib in advanced ALK Inhibitor-naïve 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
• 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
• Ou SI, Nishio M, Ahn MJ, et al. Efficacy of brigatinib in patients with advanced ALK-Positive NSCLC who progressed on alectinib or ceritinib: ALK in lung cancer trial of brigAtinib-2 (ALTA-2). J Thorac Oncol. 2022;17(12):1404–1414. doi:10.1016/j.jtho.2022.08.018
   PubMed Web of Science ®Google Scholar
• Soria JC, 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. doi:10.1016/S0140-6736(17)30123-X
   PubMed Web of Science ®Google Scholar