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?

Translational Oncology - Tập 14 - Trang 101191 - 2021
Sai-Hong Ignatius Ou1,2, Misako Nagasaka1,2,3, Danielle Brazel1, Yujie Hou4, Viola W. Zhu1,2
1University of California Irvine School of Medicine, 200 South Manchester Avenue, Suite 400, Orange, CA, United States
2Chao Family Comprehensive Cancer Center, Orange, California, United States
3St. Marianna University School of Medicine, Kawasaki, Japan
4Samuel Curtis Johnson Graduate School of Management, Cornell University, Ithaca, New York, United States

Tài liệu tham khảo

Nagasaka, 2021, Lorlatinib should be considered as the preferred first-line option in patients with advanced ALK-rearranged NSCLC, J. Thorac. Oncol., 16, 532, 10.1016/j.jtho.2020.12.021 Solomon, 2014, First-line crizotinib versus chemotherapy in ALK-positive lung cancer, N. Engl. J. Med., 371, 2167, 10.1056/NEJMoa1408440 Solomon, 2018, Final overall survival analysis from a study comparing first-line crizotinib versus chemotherapy in ALK-mutation-positive non-small-cell lung cancer, J. Clin. Oncol., 36, 2251, 10.1200/JCO.2017.77.4794 Wu, 2018, Results of PROFILE 1029, a Phase III Comparison of First-Line Crizotinib versus chemotherapy in East Asian patients with ALK-positive advanced non-small cell lung cancer, J. Thorac. Oncol., 13, 1539, 10.1016/j.jtho.2018.06.012 Soria, 2017, First-line ceritinib versus platinum-based chemotherapy in advanced ALK-rearranged non-small-cell lung cancer (ASCEND-4): a randomized, open-label, phase 3 study, Lancet, 389, 917, 10.1016/S0140-6736(17)30123-X Peters, 2017, Alectinib versus crizotinib in untreated ALK-positive non-small-cell lung cancer, N. Engl. J. Med., 377, 829, 10.1056/NEJMoa1704795 Camidge, 2019, 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, J. Thorac. Oncol., 14, 1233, 10.1016/j.jtho.2019.03.007 Hida, 2017, Alectinib versus crizotinib in patients with ALK-positive non-small-cell lung cancer (J-ALEX): an open-label, randomized phase 3 trial, Lancet, 390, 29, 10.1016/S0140-6736(17)30565-2 Nakagawa, 2020, Final progression-free survival results from the J-ALEX study of alectinib versus crizotinib in ALK-positive non-small-cell lung cancer, Lung Cancer, 139, 195, 10.1016/j.lungcan.2019.11.025 Zhou, 2019, 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., 7, 437, 10.1016/S2213-2600(19)30053-0 Camidge, 2018, Brigatinib versus crizotinib in ALK-positive non-small-cell lung cancer, N. Engl. J. Med., 379, 2027, 10.1056/NEJMoa1810171 Camidge, 2020, Brigatinib versus crizotinib in advanced ALK inhibitor-I ALK-positive non-small cell lung cancer: second interim analysis of the phase III ALTA-1L Trial, J. Clin. Oncol., 38, 3592, 10.1200/JCO.20.00505 Selvaggi, 2020, Phase 3 Randomized study of ensartinib vs crizotinib in anaplastic lymphoma kinase (ALK)–positive NSCLC patients: eXalt3, J. Thorac. Oncol., 15, 10.1016/j.jtho.2020.08.003 Shaw, 2020, First-Line Lorlatinib or crizotinib in advanced ALK-positive lung cancer, N. Engl. J. Med., 383, 2018, 10.1056/NEJMoa2027187 Drilon, 2018, Frequency of brain metastases and multikinase inhibitor outcomes in patients with RET-rearranged lung cancers, J. Thorac. Oncol., 13, 1595, 10.1016/j.jtho.2018.07.004 Gadgeel, 2018, Alectinib versus crizotinib in treatInaive anaplastic lymphoma kinase-positive (ALK+) non-small-cell lung cancer: CNS efficacy results from the ALEX study, Ann. Oncol., 29, 2214, 10.1093/annonc/mdy405 Nishio, 2018, Analysis of central nervous system efficacy in the J-ALEX study of alectinib versus crizotinib in ALK-positive non-small-cell lung cancer, Lung Cancer, 121, 37, 10.1016/j.lungcan.2018.04.015 Horn, 2019, Monitoring therapeutic response and resistance: analysis of circulating tumor DNA in patients with ALK+ lung cancer, J. Thorac. Oncol., 14, 1901, 10.1016/j.jtho.2019.08.003 Gainor, 2016, Molecular mechanisms of resistance to first- and second-generation ALK inhibitors in ALK-rearranged lung cancer, Cancer Discov., 6, 1118, 10.1158/2159-8290.CD-16-0596 Qiao, 2016, Cracking the code of resistance across Multiple Lines of ALK inhibitor therapy in lung cancer, Cancer Discov., 6, 1084, 10.1158/2159-8290.CD-16-0910 Johnson, 2014, J. Med. Chem., 57, 4720, 10.1021/jm500261q Zou, 2015, PF-06463922, an ALK/ROS1 inhibitor, overcomes resistance to first and second generation ALK inhibitors in preclinical models, Cancer Cell, 28, 70, 10.1016/j.ccell.2015.05.010 Camidge, 2021, Lorlatinib should not be considered as the preferred first-line option in patients with advanced ALK rearranged NSCLC, J. Thorac. Oncol., 16, 528, 10.1016/j.jtho.2020.12.022 Yoda, 2018, Sequential ALK inhibitors can select for lorlatinib-resistant compound ALK mutations in ALK-positive lung cancer, Cancer Discov., 8, 714, 10.1158/2159-8290.CD-17-1256 Dagogo-Jack, 2019, Treatment with next-generation ALK inhibitors fuels plasma ALK mutation diversity, Clin. Cancer Res., 25, 6662, 10.1158/1078-0432.CCR-19-1436 Okada, 2019, Prediction of ALK mutations mediating ALK-TKIs resistance and drug re-purposing to overcome the resistance, EBioMedicine, 10.1016/j.ebiom.2019.01.019 Zhu, 2020, A novel sequentially evolved EML4-ALK v3 G1202R/S1206Y in cis double mutation confers resistance to lorlatinib: a brief report and literature review, JTO Clin. Res. Rep., 2 Papadopoulos, 2020, U.S. phase I first-in-human study of taletrectinib (DS-6051b/AB-106), a ROS1/TRK inhibitor, in patients with advanced solid tumors, Clin. Cancer Res., 26, 4785, 10.1158/1078-0432.CCR-20-1630 Lin, 2021, Spectrum of mechanisms of resistance to crizotinib and lorlatinib in ROS1 fusion-positive lung cancer, Clin. Cancer Res., 27, 2899, 10.1158/1078-0432.CCR-21-0032 Solomon, 2018, Lorlatinib in patients with ALK-positive non-small-cell lung cancer: results from a global phase 2 study, Lancet Oncol., 19, 1654, 10.1016/S1470-2045(18)30649-1 Zhu, 2020, An International real-world analysis of the efficacy and safety of lorlatinib through early or expanded access programs in patients with tyrosine kinase inhibitor-refractory ALK-positive or ROS1-positive NSCLC, J. Thorac. Oncol., 15, 1484, 10.1016/j.jtho.2020.04.019 Lin, 2018, Brigatinib in patients with alectinib-refractory ALK-positive NSCLC, J. Thorac. Oncol., 13, 1530, 10.1016/j.jtho.2018.06.005 Nishio, 2021, Brigatinib in Japanese patients with ALK-positive NSCLC previously treated with alectinib and other tyrosine kinase inhibitors: outcomes of the phase 2J-ALTA trial, J. Thorac. Oncol., 16, 452, 10.1016/j.jtho.2020.11.004 Kim, 2021, 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., 17, 1709, 10.2217/fon-2020-1119 Cui, 2020, TPX-0131: a next generation macrocyclic ALK Inhibitor that overcomes ALK resistant mutations refractory to currently approved ALK inhibitors, 80 Murray, 2021, TPX-0131, a potent CNS-penetrant, next-generation inhibitor of wild-type ALK and ALK-resistant mutations, Mol. Cancer Ther., 10.1158/1535-7163.MCT-21-0221 Pelish, 2021, NVL-655 is a selective, brain-penetrant ALK inhibitor with antitumor activity against the lorlatinib-resistant G1202R/L1196M compound mutation, AACR Zhang, 2021, 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, 10.1016/j.lungcan.2021.06.012 Ou, 2020, Catalog of 5’ fusion partners in ALK- positive NSCLC Circa 2020, JTO Clin. Res. Rep., 1 Heuckmann, 2012, Differential protein stability and ALK inhibitor sensitivity of EML4-ALK fusion variants, Clin. Cancer Res., 18, 4682, 10.1158/1078-0432.CCR-11-3260 Workman, 2014, EML4-ALK fusions: propelling cancer but creating exploitable chaperone dependence, Cancer Discov., 4, 642, 10.1158/2159-8290.CD-14-0409 Dagogo-Jack, 2020, MET Alterations are a recurring and actionable resistance mechanism in ALK-positive lung cancer, Clin. Cancer Res., 26, 2535, 10.1158/1078-0432.CCR-19-3906 Lin, 2020, Mechanisms of resistance to selective RET tyrosine kinase inhibitors in RET fusion-positive non-small-cell lung cancer, Ann. Oncol., 31, 1725, 10.1016/j.annonc.2020.09.015 Rosen, 2021, Overcoming MET-dependent resistance to selective RET inhibition in patients with RET fusion-positive lung cancer by combining selpercatinib with crizotinib, Clin. Cancer Res., 27, 34, 10.1158/1078-0432.CCR-20-2278 Zhu, 2021, Acquired tertiary MET resistances (MET D1228N and a novel LSM8-MET fusion) to selpercatinib and capmatinib combination in a KIF5B-RET+ NSCLC patient who acquired MET amplification as initial resistance to selpercatinib, J. Thorac. Oncol., 10.1016/j.jtho.2021.03.006 Coco, 2018, NTRK fusion-positive cancers and TRK inhibitor therapy, Nat. Rev. Clin. Oncol., 15, 731, 10.1038/s41571-018-0113-0 Bauer, 2019, Clinical management of adverse events associated with lorlatinib, Oncologist, 24, 1103, 10.1634/theoncologist.2018-0380 Nagasaka, 2020, A user's guide to lorlatinib, Crit. Rev. Oncol. Hematol., 151, 10.1016/j.critrevonc.2020.102969 Socinski, 2018, Atezolizumab for first-line treatment of metastatic nonsquamous NSCLC, N. Engl. J. Med., 378, 2288, 10.1056/NEJMoa1716948 https://www.ema.europa.eu/en/documents/overview/tecentriq-epar-medicine-overview_en.pdf (assessed June 11, 2021) 2021. Reck, 2019, IMpower150: an exploratory analysis of efficacy outcomes in patients with EGFR mutations. Presented at: 2019 European Society of Medical Oncology, Ann. Oncol., 30, ii38 Reck, 2019, Atezolizumab plus bevacizumab and chemotherapy in non-small-cell lung cancer (IMpower150): key subgroup analyses of patients with EGFR mutations or baseline liver metastases in a randomised, open-label phase 3 trial, Lancet Respir. Med., 7, 387, 10.1016/S2213-2600(19)30084-0 Lin, 2020, Efficacy of platinum/pemetrexed combination chemotherapy in ALK-positive NSCLC refractory to second-generation ALK inhibitors, J. Thorac. Oncol., 15, 258, 10.1016/j.jtho.2019.10.014 Ou, 2014, Will the requirement by the US FDA to simultaneously co-develop companion diagnostics (CDx) delay the approval of receptor tyrosine kinase inhibitors for RTK-rearranged (ROS1-, RET-, AXL-, PDGFR-alpha-, NTRK1-) non-small cell lung cancer globally?, Front. Oncol., 4, 58, 10.3389/fonc.2014.00058 Lin, 2018, Impact of EML4-ALK variant on resistance mechanisms and clinical outcomes in ALK-positive lung cancer, J. Clin. Oncol., 36, 1199, 10.1200/JCO.2017.76.2294