Necitumumab in the treatment of non-small-cell lung cancer: clinical controversies

References

• Wong MCS, Lao XQ, Ho KF, et al. Incidence and mortality of lung cancer: global trends and association with socioeconomic status. Sci Rep. 2017 Oct 30;7(1):14300.
   PubMedGoogle Scholar
• Hirsch FR, Scagliotti GV, Mulshine JL, et al. Lung cancer: current therapies and new targeted treatments. Lancet. 2017 Jan 21;389(10066):299–311.
   PubMed Web of Science ®Google Scholar
• Schiller JH, Harrington D, Belani CP, et al. Comparison of four chemotherapy regimens for advanced non-small-cell lung cancer. N Engl J Med. 2002 Jan 10;346(2):92–98.
   PubMed Web of Science ®Google Scholar
• Bria E, Milella M, Cuppone F, et al. Outcome of advanced NSCLC patients harboring sensitizing EGFR mutations randomized to EGFR tyrosine kinase inhibitors or chemotherapy as first-line treatment: a meta-analysis. Ann Oncol. 2011 Oct;22(10):2277–2285.
   PubMed Web of Science ®Google Scholar
• Maemondo M, Inoue A, Kobayashi K, et al. Gefitinib or chemotherapy for non-small-cell lung cancer with mutated EGFR. N Engl J Med. 2010 Jun 24;362(25):2380–2388.
   PubMed Web of Science ®Google Scholar
• Mitsudomi T, Morita S, Yatabe Y, et al. Gefitinib versus cisplatin plus docetaxel in patients with non-small-cell lung cancer harbouring mutations of the epidermal growth factor receptor (WJTOG3405): an open label, randomised phase 3 trial. Lancet Oncol. 2010 Feb;11(2):121–128.
   PubMed Web of Science ®Google Scholar
• Mok TS, Wu YL, Thongprasert S, et al. Gefitinib or carboplatin–paclitaxel in pulmonary adenocarcinoma. N Engl J Med. 2009 Sep 3;361(10):947–957.
   PubMed Web of Science ®Google Scholar
• Rosell R, Carcereny E, Gervais R, et al. Erlotinib versus standard chemotherapy as first-line treatment for European patients with advanced EGFR mutation-positive non-small-cell lung cancer (EURTAC): a multicentre, open-label, randomised phase 3 trial. Lancet Oncol. 2012 Mar;13(3):239–246.
   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 Dec 4;371(23):2167–2177.
   PubMed Web of Science ®Google Scholar
• Borghaei H, Paz-Ares L, Horn L, et al. Nivolumab versus docetaxel in advanced nonsquamous non-small-cell lung cancer. N Engl J Med. 2015 Oct 22;373(17):1627–1639.
   PubMed Web of Science ®Google Scholar
• Brahmer J, Reckamp KL, Baas P, et al. Nivolumab versus docetaxel in advanced squamous-cell non-small-cell lung cancer. N Engl J Med. 2015 Jul 09;373(2):123–135.
   PubMed Web of Science ®Google Scholar
• Reck M, Rodriguez-Abreu D, Robinson AG, et al. Pembrolizumab versus chemotherapy for PD-L1-positive non-small-cell lung cancer. N Engl J Med. 2016 Nov 10;375(19):1823–1833.
   PubMed Web of Science ®Google Scholar
• Herbst RS, Baas P, Kim DW, et al. Pembrolizumab versus docetaxel for previously treated, PD-L1-positive, advanced non-small-cell lung cancer (KEYNOTE-010): a randomised controlled trial. Lancet. 2016 Apr 9;387(10027):1540–1550.
   PubMed Web of Science ®Google Scholar
• Rittmeyer A, Barlesi F, Waterkamp D, et al. Atezolizumab versus docetaxel in patients with previously treated non-small-cell lung cancer (OAK): a phase 3, open-label, multicentre randomised controlled trial. Lancet. 2017 Jan 21;389(10066):255–265.
   PubMed Web of Science ®Google Scholar
• Barlesi F, Mazieres J, Merlio JP, et al. Routine molecular profiling of patients with advanced non-small-cell lung cancer: results of a 1-year nationwide programme of the French Cooperative Thoracic Intergroup (IFCT). Lancet. 2016 Apr 2;387(10026):1415–1426.
   PubMed Web of Science ®Google Scholar
• Socinski MA, Obasaju C, Gandara D, et al. Current and emergent therapy options for advanced squamous cell lung cancer. J Thorac Oncol. 2018 Feb;13(2):165–183.
   PubMed Web of Science ®Google Scholar
• Cancer Genome Atlas Research N. Comprehensive genomic characterization of squamous cell lung cancers. Nature. 2012 Sep 27;489(7417):519–525.
   PubMed Web of Science ®Google Scholar
• Heist RS, Mino-Kenudson M, Sequist LV, et al. FGFR1 amplification in squamous cell carcinoma of the lung. J Thorac Oncol. 2012 Dec;7(12):1775–1780.
   PubMed Web of Science ®Google Scholar
• Rekhtman N, Paik PK, Arcila ME, et al. Clarifying the spectrum of driver oncogene mutations in biomarker-verified squamous carcinoma of lung: lack of EGFR/KRAS and presence of PIK3CA/AKT1 mutations. Clin Cancer Res. 2012 Feb 15;18(4):1167–1176.
   PubMed Web of Science ®Google Scholar
• Hirsch FR, Varella-Garcia M, Bunn PA Jr., et al. Epidermal growth factor receptor in non-small-cell lung carcinomas: correlation between gene copy number and protein expression and impact on prognosis. J Clinical Oncology: Official Journal Am Soc Clin Oncol. 2003 Oct 15;21(20):3798–3807.
   PubMed Web of Science ®Google Scholar
• Liu TC, Jin X, Wang Y, et al. Role of epidermal growth factor receptor in lung cancer and targeted therapies. Am J Cancer Res. 2017;7(2):187–202.
   PubMed Web of Science ®Google Scholar
• Pirker R, Pereira JR, Szczesna A, et al. Cetuximab plus chemotherapy in patients with advanced non-small-cell lung cancer (FLEX): an open-label randomised phase III trial. Lancet. 2009 May 2;373(9674):1525–1531.
   PubMed Web of Science ®Google Scholar
• Lynch TJ, Patel T, Dreisbach L, et al. Cetuximab and first-line taxane/carboplatin chemotherapy in advanced non-small-cell lung cancer: results of the randomized multicenter phase III trial BMS099. J Clinical Oncology: Official Journal Am Soc Clin Oncol. 2010 Feb 20;28(6):911–917.
   PubMed Web of Science ®Google Scholar
• Pirker R, Pereira JR, von Pawel J, et al. EGFR expression as a predictor of survival for first-line chemotherapy plus cetuximab in patients with advanced non-small-cell lung cancer: analysis of data from the phase 3 FLEX study. Lancet Oncol. 2012 Jan;13(1):33–42.
   PubMed Web of Science ®Google Scholar
• Pujol JL, Pirker R, Lynch TJ, et al. Meta-analysis of individual patient data from randomized trials of chemotherapy plus cetuximab as first-line treatment for advanced non-small cell lung cancer. Lung Cancer. 2014 Feb;83(2):211–218.
   PubMed Web of Science ®Google Scholar
• Schmitz KR, Bagchi A, Roovers RC, et al. Structural evaluation of EGFR inhibition mechanisms for nanobodies/VHH domains. Structure. 2013 Jul 2;21(7):1214–1224.
   PubMed Web of Science ®Google Scholar
• Li S, Kussie P, Ferguson KM. Structural basis for EGF receptor inhibition by the therapeutic antibody IMC-11F8. Structure. 2008 Feb;16(2):216–227.
   PubMed Web of Science ®Google Scholar
• Bagchi A, Haidar JN, Eastman SW, et al. Molecular basis for necitumumab inhibition of EGFR variants associated with acquired cetuximab resistance. Mol Cancer Ther. 2018 Feb;17(2):521–531.
   PubMed Web of Science ®Google Scholar
• Bakema JE, van Egmond M. Fc receptor-dependent mechanisms of monoclonal antibody therapy of cancer. Curr Top Microbiol Immunol. 2014;382:373–392.
   PubMed Web of Science ®Google Scholar
• Kuenen B, Witteveen PO, Ruijter R, et al. A phase I pharmacologic study of necitumumab (IMC-11F8), a fully human IgG1 monoclonal antibody directed against EGFR in patients with advanced solid malignancies. Clin Cancer Res. 2010 Mar 15;16(6):1915–1923.
   PubMed Web of Science ®Google Scholar
• Ryman JT, Meibohm B. Pharmacokinetics of monoclonal antibodies. CPT Pharmacometrics Syst Pharmacol. 2017 Sep;6(9):576–588.
   PubMedGoogle Scholar
• Saxena B, Sundaram ST, Walton W, et al. Differentiation between the EGFR antibodies necitumumab, cetuximab, and panitumumab: in vitro biological and binding activities. J Clin Oncol. 2011;29(15_suppl):e13030–e30.
   Web of Science ®Google Scholar
• Patel D, Saxena B, Zhou Q, et al. Differential induction of antibody-dependent cellular cytotoxicity (ADCC) against human EGFR-expressing NSCLC cell lines by necitumumab, cetuximab, and panitumumab. J Clin Oncol. 2011;29(15_suppl):e21075–e75.
   Google Scholar
• Samakoglu S, Deevi DS, Li H, et al. Preclinical rationale for combining an EGFR antibody with cisplatin/gemcitabine for the treatment of NSCLC. Cancer Genomics Proteomics. 2012 Mar-Apr;9(2):77–92.
   PubMed Web of Science ®Google Scholar
• Nokihara H, Yamamoto N, Tamura Y, et al. O3-9-2A phase 1 study of necitumumab (Anti-EGFR monoclonal antibody) in Japanese patients with advanced solid tumors. Ann Oncol. 2014;25(suppl_5):v70–v70.
   Google Scholar
• Besse B, Garrido Lopez P, Puente J, et al. 1309PEfficacy and safety of necitumumab and pembrolizumab combination therapy in patients with stage IV non-small cell lung cancer (NSCLC). Ann Oncol. 2017;28(suppl_5):mdx380.012-mdx380.012.
   Google Scholar
• Corral J, Ponce SAerts J, et al. CTe. A phase II study of gemcitabine-cisplatin plus necitumumab for stage IV Sq-NSCLC. WCLC 2015: J Thorac Oncol. 2015;S407–S760.
   Google Scholar
• Spigel DR, Luft A, Depenbrock H, et al. An Open-label, randomized, controlled phase II study of paclitaxel-carboplatin chemotherapy with necitumumab versus paclitaxel-carboplatin alone in first-line treatment of patients with stage IV squamous non-small-cell lung cancer. Clin Lung Cancer. 2017 Sep;18(5):480–488.
   PubMed Web of Science ®Google Scholar
• Paz-Ares L, Mezger J, Ciuleanu TE, et al. Necitumumab plus pemetrexed and cisplatin as first-line therapy in patients with stage IV non-squamous non-small-cell lung cancer (INSPIRE): an open-label, randomised, controlled phase 3 study. Lancet Oncol. 2015 Mar;16(3):328–337.
   PubMed Web of Science ®Google Scholar
• Thatcher N, Hirsch FR, Luft AV, et al. Necitumumab plus gemcitabine and cisplatin versus gemcitabine and cisplatin alone as first-line therapy in patients with stage IV squamous non-small-cell lung cancer (SQUIRE): an open-label, randomised, controlled phase 3 trial. Lancet Oncol. 2015 Jul;16(7):763–774.
   PubMed Web of Science ®Google Scholar
• Socinski MA, Paz-Ares L, Luft AV, et al. 1232PSQUIRE: a randomized, multicenter, open-label, phase III study of gemcitabine-cisplatin (GC) chemotherapy plus necitumumab (IMC-11f8/ly3012211) vs gc alone in the first-line treatment of patients (PTS) with stage iv squamous non-small cell lung cancer (SQ-NSCLC): update on key subgroups. Ann Oncol. 2014;25(suppl_4):iv430–iv31.
   Google Scholar
• Socinski MA, Luft A, Szczesna A, et al. Subgroup analyses by performance status (PS) in the phase III SQUIRE study: first-line necitumumab (N) plus gemcitabine-cisplatin (GC) vs. GC in squamous non-small cell lung cancer (NSCLC). J Clin Oncol. 2015;33(15_suppl):e19023–e23.
   Web of Science ®Google Scholar
• Thatcher N, Ciuleanu TE, Ramlau R, et al. 103PDSUBGROUP analysis of elderly patients in squire: a randomized, multicenter, open-label, phase III study of Necitumumab (N) plus Gemcitabine-Cisplatin (GC) chemotherapy versus GC alone in first-line treatment of patients (PTS) with stage IV Squamous Non-Small Cell Lung Cancer (SQ-NSCLC). Ann Oncol. 2015;26(suppl_1):i32–i32.
   Google Scholar
• Park K, Cho EK, Bello M, et al. Efficacy and safety of first-line necitumumab plus gemcitabine and cisplatin versus gemcitabine and cisplatin in east asian patients with stage IV squamous non-small cell lung cancer: a subgroup analysis of the phase 3, open-label, randomized SQUIRE study. Cancer Res Treat. 2017 Oct;49(4):937–946.
   PubMedGoogle Scholar
• Reck M, Socinski MA, Luft A, et al. The effect of necitumumab in combination with gemcitabine plus cisplatin on tolerability and on quality of life: results from the phase 3 SQUIRE trial. J Thorac Oncol. 2016 Jun;11(6):808–818.
   PubMed Web of Science ®Google Scholar
• Paz-Ares L, Socinski MA, Shahidi J, et al. Correlation of EGFR-expression with safety and efficacy outcomes in SQUIRE: a randomized, multicenter, open-label, phase III study of gemcitabine-cisplatin plus necitumumab versus gemcitabine-cisplatin alone in the first-line treatment of patients with stage IV squamous non-small-cell lung cancer. Ann Oncol. 2016 Aug;27(8):1573–1579.
   PubMed Web of Science ®Google Scholar
• Goldstein DA, Chen Q, Ayer T, et al. Necitumumab in metastatic squamous cell lung cancer: establishing a value-based cost. JAMA Oncology. 2015 Dec;1(9):1293–1300.
   PubMed Web of Science ®Google Scholar
• Besse B, Vansteenkiste J, Renault P-A, et al. P3.02b-062 safety of necitumumab and abemaciclib combination therapy in patients with advanced Non-Small Cell Lung Cancer (NSCLC). J Thorac Oncol. 2017;12(1):S1227–S28.
   Web of Science ®Google Scholar
• Johnson M, Wacheck V, Hussein M, et al. A phase 2 study of LY3023414 and necitumumab after first-line chemotherapy for metastatic squamous non-small cell lung cancer (NSCLC). Ann Oncol. 2016;27(suppl_6):1274P–74P.
   Google Scholar
• Petrelli F, Cabiddu M, Borgonovo K, et al. Risk of venous and arterial thromboembolic events associated with anti-EGFR agents: a meta-analysis of randomized clinical trials. Ann Oncol. 2012 Jul;23(7):1672–1679.
   PubMed Web of Science ®Google Scholar
• Di Fiore F, Blanchard F, Charbonnier F, et al. Clinical relevance of KRAS mutation detection in metastatic colorectal cancer treated by Cetuximab plus chemotherapy. Br J Cancer. 2007 Apr 23;96(8):1166–1169.
   PubMed Web of Science ®Google Scholar
• Lievre A, Bachet JB, Boige V, et al. KRAS mutations as an independent prognostic factor in patients with advanced colorectal cancer treated with cetuximab. J Clinical Oncology: Official Journal Am Soc Clin Oncol. 2008 Jan 20;26(3):374–379.
   PubMed Web of Science ®Google Scholar
• Mao C, Qiu LX, Liao RY, et al. KRAS mutations and resistance to EGFR-TKIs treatment in patients with non-small cell lung cancer: a meta-analysis of 22 studies. Lung Cancer. 2010 Sep;69(3):272–278.
   PubMed Web of Science ®Google Scholar
• Khambata-Ford S, Harbison CT, Hart LL, et al. Analysis of potential predictive markers of cetuximab benefit in BMS099, a phase III study of cetuximab and first-line taxane/carboplatin in advanced non-small-cell lung cancer. J Clinical Oncology: Official Journal Am Soc Clin Oncol. 2010 Feb 20;28(6):918–927.
   PubMed Web of Science ®Google Scholar
• O’Byrne KJ, Gatzemeier U, Bondarenko I, et al. Molecular biomarkers in non-small-cell lung cancer: a retrospective analysis of data from the phase 3 FLEX study. Lancet Oncol. 2011 Aug;12(8):795–805.
   PubMed Web of Science ®Google Scholar