Phase I results of S49076 plus gefitinib in patients with EGFR TKI-resistant non-small cell lung cancer harbouring MET/AXL dysregulation

Lung Cancer - Tập 155 - Trang 127-135 - 2021
Keunchil Park1, Gee-Chen Chang2,3,4, Giuseppe Curigliano5,6, Wan-Teck Lim7, Ross A. Soo8, Miguel A. Molina-Vila9, Valérie Cattan10, Hélène Darville11, Eric Gandossi10, Veronika Smutna10, Isabelle Sudey10, Santiago Viteri12
1Division of Hematology and Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine, 81 Irwon-ro, Gangnam-gu, 06351, Seoul, Republic of Korea
2Division of Chest Medicine, Department of Internal Medicine, Taichung Veterans General Hospital, No. 1650, Sect. 4, Taiwan Boulevard, Taichung, 407, Taiwan
3Division of Pulmonary Medicine, Department of Internal Medicine, Chung Shan Medical University Hospital, No. 110, Sec. 1, Jianguo N. Road, Taichung, 402, Taiwan
4School of Medicine, and Institute of Medicine, Chung Shan Medical University, No. 110, Sec. 1, Jianguo N. Road, Taichung, 402, Taiwan
5Istituto Europeo di Oncologia, IRCCS, Divisione Sviluppo Nuovi Farmaci per Terapie Innovative,Via Ripamonti, 435, 20141, Milano, Italy
6University of Milano, Milano, Italy
7National Cancer Centre Singapore, Vision of Medical Oncology, 11 Hospital Drive, Singapore, 169610, Singapore
8National University Cancer Institute, Department of Haematology-Oncology, 1E Kent Ridge Road, NUHS Tower Block Level 7, Singapore, 119228, Singapore
9Pangaea Oncology, Laboratory of Molecular Biology, Quiron-Dexeus University Institute, Barcelona, Spain
10Institut de Recherches Internationales Servier (I.R.I.S.), 50 rue Carnot, 92284, Suresnes, France
11Institut de Recherche Servier, 125 Chemin de Ronde, 78290 Croissy-sur-Seine, France
12Instituto Oncológico Dr. Rosell (IOR), Servicio Oncología Médica, Hospital Uni. Quirón-Dexeus, C/ Sabino Arana 5-19, 08028, Barcelona, Spain

Tài liệu tham khảo

Mitsudomi, 2014, Molecular epidemiology of lung cancer and geographic variations with special reference to EGFR mutations, Transl. Lung Cancer Res., 3, 205 Shigematsu, 2005, Clinical and biological features associated with epidermal growth factor receptor gene mutations in lung cancers, J. Natl. Cancer Inst., 97, 339, 10.1093/jnci/dji055 Rosell, 2009, Screening for epidermal growth factor receptor mutations in lung cancer, N. Engl. J. Med., 361, 958, 10.1056/NEJMoa0904554 Planchard, 2019, Metastatic non-small cell lung cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up, Ann. Oncol., 30, 863, 10.1093/annonc/mdy474 National Comprehensive Cancer Network (NCNN), 2019 Hanna, 2017, Systemic therapy for stage IV non-small-cell lung cancer: American Society of Clinical Oncology clinical practice guideline update, J. Clin. Oncol., 35, 3484, 10.1200/JCO.2017.74.6065 Lee, 2013, Impact of EGFR inhibitor in non–small cell lung cancer on progression-free and overall survival: a meta-analysis, J. Natl. Cancer Inst., 105, 595, 10.1093/jnci/djt072 Gridelli, 2011, Gefitinib as first-line treatment for patients with advanced non-small-cell lung cancer with activating epidermal growth factor receptor mutation: review of the evidence, Lung Cancer, 71, 249, 10.1016/j.lungcan.2010.12.008 Jackman, 2010, Clinical definition of acquired resistance to epidermal growth factor receptor tyrosine kinase inhibitors in non–small-cell lung cancer, J. Clin. Oncol., 28, 357, 10.1200/JCO.2009.24.7049 Oxnard, 2011, Maintained sensitivity to EGFR tyrosine kinase inhibitors in EGFR-mutant lung cancer recurring after adjuvant erlotinib or gefitinib, Clin. Cancer Res., 17, 6322, 10.1158/1078-0432.CCR-11-1080 Kwak, 2005, Irreversible inhibitors of the EGF receptor may circumvent acquired resistance to gefitinib, Proc. Nat. Acad. Sci. U. S. A., 102, 7665, 10.1073/pnas.0502860102 Kobayashi, 2005, EGFR mutation and resistance of non–small-cell lung cancer to gefitinib, N. Engl. J. Med., 352, 786, 10.1056/NEJMoa044238 Song, 2019, Am. J. Clin. Oncol., 42, 432, 10.1097/COC.0000000000000538 Corallo, 2017, Treatment options for EGFR T790M-negative EGFR tyrosine kinase inhibitor-resistant non-small cell lung cancer, Target. Oncol., 12, 153, 10.1007/s11523-017-0479-4 Yu, 2013, 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., 19, 2240, 10.1158/1078-0432.CCR-12-2246 Bean, 2007, MET amplification occurs with or without T790M mutations in EGFR mutant lung tumors with acquired resistance to gefitinib or erlotinib, Proc. Natl. Acad. Sci. U. S. A., 104, 20932, 10.1073/pnas.0710370104 Noro, 2015, MET FISH-positive status predicts short progression-free survival and overall survival after gefitinib treatment in lung adenocarcinoma with EGFR mutation, BMC Cancer, 15, 31, 10.1186/s12885-015-1019-1 Spigel, 2013, Randomized phase II trial of onartuzumab in combination with erlotinib in patients with advanced non–small-cell lung cancer, J. Clin. Oncol., 31, 4105, 10.1200/JCO.2012.47.4189 Miranda, 2018, Status of agents targeting the HGF/c-Met axis in lung cancer, Cancers, 10, 280, 10.3390/cancers10090280 Engelman, 2007, MET amplification leads to gefitinib resistance in lung cancer by activating ERBB3 signaling, Science, 316, 1039, 10.1126/science.1141478 Zhang, 2018, Function of Axl receptor tyrosine kinase in non-small cell lung cancer, Oncol. Lett., 15, 2726 Seike, 2017, AXL and GAS6 co-expression in lung adenocarcinoma as a prognostic classifier, Oncol. Rep., 37, 3261, 10.3892/or.2017.5594 Kim, 2015, Multiple resistant factors in lung cancer with primary resistance to EGFR-TK inhibitors confer poor survival, Lung Cancer, 88, 139, 10.1016/j.lungcan.2015.01.023 Ji, 2013, Mechanisms of acquired resistance to EGFR-tyrosine kinase inhibitor in Korean patients with lung cancer, BMC Cancer, 13, 606, 10.1186/1471-2407-13-606 Zhang, 2012, Activation of the AXL kinase causes resistance to EGFR-targeted therapy in lung cancer, Nat. Genet., 44, 852, 10.1038/ng.2330 Burbridge, 2013, S49076 is a novel kinase inhibitor of MET, AXL, and FGFR with strong preclinical activity alone and in association with bevacizumab, Mol. Cancer Ther., 12, 1749, 10.1158/1535-7163.MCT-13-0075 Park, 2017, 1379TiP phase I/II study of S 49076, a MET/AXL/FGFR inhibitor, in combination with gefitinib in EGFR-mutated NSCLC patients who progress on EGFR tyrosine kinase inhibitor. 42nd ESMO Congress 2017 Sept 8-12; Madrid, Spain, Ann. Oncol., 28, 493, 10.1093/annonc/mdx380.080 Rodon, 2017, First-in-human phase I study of oral S49076, a unique MET/AXL/FGFR inhibitor, in advanced solid tumours, Eur. J. Cancer, 81, 142, 10.1016/j.ejca.2017.05.007 Eisenhauer, 2009, New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1), Eur. J. Cancer, 45, 228, 10.1016/j.ejca.2008.10.026 Saal, 2016 Wu, 2018, Phase Ib/II study of capmatinib (INC280) plus gefitinib after failure of epidermal growth factor receptor (EGFR) inhibitor therapy in patients with EGFR-mutated, MET factor-dysregulated non-small-cell lung cancer, J. Clin. Oncol., 36, 3101, 10.1200/JCO.2018.77.7326 Gou, 2016, The coexistence of MET over-expression and an EGFR T790M mutation is related to acquired resistance to EGFR tyrosine kinase inhibitors in advanced non-small cell lung cancer, Oncotarget, 7, 51311, 10.18632/oncotarget.9697 Weingertner, 2015, Correlation between MET protein expression and MET gene copy number in a Caucasian cohort of non-small cell lung cancers according to the new IASLC/ATS/ERS classification, Pathology, 47, 320, 10.1097/PAT.0000000000000269 Kujtan, 2019, Epidermal growth factor receptor tyrosine kinase inhibitors for the treatment of non-small cell lung cancer, Expert Rev. Anticancer Ther., 19, 547, 10.1080/14737140.2019.1596030 Current Controlled Trials: ISRCTN00759419, phase I dose-escalation study of S49076 in patients with advanced solid tumours. London: BioMed Central. http://www.isrctn.com/ISRCTN00759419. (Accessed 10 September 2019). Wang, 2019, MET inhibitors for targeted therapy of EGFR TKI-resistant lung cancer, J. Hematol. Oncol., 12, 63, 10.1186/s13045-019-0759-9 Cardona, 2017, Acquired resistance to Erlotinib in EGFR mutation-positive lung adenocarcinoma among Hispanics (CLICaP), Target. Oncol., 12, 513, 10.1007/s11523-017-0497-2 Takezawa, 2012, HER2 amplification: a potential mechanism of acquired resistance to EGFR inhibition in EGFR-mutant lung cancers that lack the second-site EGFRT790M mutation, Cancer Discov., 922, 10.1158/2159-8290.CD-12-0108 Li, 2018, Uncommon EGFR G724S mutations arise in non-small-cell lung cancer patients with acquired resistance to first-generation EGFR-TKIs, Lung Cancer, 118, 173, 10.1016/j.lungcan.2018.02.016 Santoni-Rugiu, 2019, Intrinsic resistance to EGFR-tyrosine kinase inhibitors in EGFR-mutant non-small cell lung cancer: differences and similarities with acquired resistance, Cancers, 11, 923, 10.3390/cancers11070923 De Marchi, 2019, Clinical validation of coexisting activating mutations within EGFR, mitogen-activated protein kinase, and phosphatidylinositol 3-kinase pathways in lung cancers, Arch. Pathol. Lab. Med., 143, 174, 10.5858/arpa.2017-0495-OA Ramalingam, 2018, LBA50 Mechanisms of acquired resistance to first-line osimertinib: preliminary data from the phase III FLAURA study, Ann. Oncol., 29, 10.1093/annonc/mdy424.063