Spotlight on Trastuzumab Deruxtecan (DS-8201,T-DXd) for HER2 Mutation Positive Non-Small Cell Lung Cancer

References

• King C, Kraus M, Aaronson S. Amplification of a novel v-erbB-related gene in a human mammary carcinoma. Science. 1985;229(4717):974–976. doi:10.1126/science.2992089
   PubMed Web of Science ®Google Scholar
• Klapper LN, Glathe S, Vaisman N, et al. The ErbB-2/HER2 oncoprotein of human carcinomas may function solely as a shared coreceptor for multiple stroma-derived growth factors. Proc Natl Acad Sci. 1999;96(9):4995–5000.
   PubMed Web of Science ®Google Scholar
• Giatromanolaki A, Koukourakis Mi, Simopoulos C, et al. c-erbB-2 related aggressiveness in breast cancer is hypoxia inducible factor-1α dependent. Clin Cancer Res. 2004;10(23):7972–7977.
   Web of Science ®Google Scholar
• Gassmann M, Casagranda F, Orioli D, et al. Aberrant neural and cardiac development in mice lacking the ErbB4 neuregulin receptor. Nature. 1995;378(6555):390–394.
   PubMed Web of Science ®Google Scholar
• Threadgill D, Dlugosz A, Hansen L, et al. Targeted disruption of mouse EGF receptor: effect of genetic background on mutant phenotype. Science. 1995;269(5221):230–234.
   PubMed Web of Science ®Google Scholar
• Kerbel RS, Viloria-Petit A, Klement G, Rak J. ‘Accidental’ anti-angiogenic drugs. Eur J Cancer. 2000;36(10):1248–1257.
   PubMed Web of Science ®Google Scholar
• O-charoenrat P, Rhys-Evans P, Court WJ, Box GM, Eccles SA. Differential modulation of proliferation, matrix metalloproteinase expression and invasion of human head and neck squamous carcinoma cells by c-erbB ligands. Clin Exp Metastasis. 1999;17(7):631–639.
   Web of Science ®Google Scholar
• Ménard S, Pupa SM, Campiglio M, Tagliabue E. Biologic and therapeutic role of HER2 in cancer. Oncogene. 2003;22(42):6570–6578.
   PubMed Web of Science ®Google Scholar
• Landi L, Cappuzzo F. HER2 and lung cancer. Expert Rev Anticancer Ther. 2013;13(10):1219–1228.
   PubMed Web of Science ®Google Scholar
• Slamon D, Godolphin W, Jones L, et al. Studies of the HER-2/neu proto-oncogene in human breast and ovarian cancer. Science. 1989;244(4905):707–712. doi:10.1126/science.2470152
   PubMed Web of Science ®Google Scholar
• Leonetti A, Sharma S, Minari R, Perego P, Giovannetti E, Tiseo M. Resistance mechanisms to osimertinib in EGFR-mutated non-small cell lung cancer. Br J Cancer. 2019;121(9):725–737.
   PubMed Web of Science ®Google Scholar
• Ramalingam SS, Cheng Y, Zhou C, et al. Mechanisms of acquired resistance to first-line osimertinib: preliminary data from the Phase III FLAURA study. Ann Oncol. 2018;29:vii740.
   Google Scholar
• Papadimitrakopoulou VA, Wu Y-L, Han J-Y, et al. Analysis of resistance mechanisms to osimertinib in patients with EGFR T790M advanced NSCLC from the AURA3 study. Ann Oncol. 2018;29:vii740.
   Web of Science ®Google Scholar
• Pallis AG, Syrigos KN. Lung cancer in never smokers: disease characteristics and risk factors. Crit Rev Oncol Hematol. 2013;88(3):494–503.
   PubMed Web of Science ®Google Scholar
• Mar N, Vredenburgh JJ, Wasser JS. Targeting HER2 in the treatment of non-small cell lung cancer. Lung Cancer. 2015;87(3):220–225.
   PubMed Web of Science ®Google Scholar
• Hotta K, Yanai H, Ohashi K, et al. Pilot evaluation of a HER2 testing in non-small-cell lung cancer. J Clin Pathol. 2020;73(6):353–357.
   PubMed Web of Science ®Google Scholar
• Ding Q, Chen H, Lim B, et al. HER2 somatic mutation analysis in breast cancer: correlation with clinicopathological features. Hum Pathol. 2019;92:32–38.
   Web of Science ®Google Scholar
• Lengyel CG, Habeeb B, Khan SZ, et al. Role of HER-2 in gastrointestinal tumours beyond gastric cancer: a tool for precision medicine. Gastrointestinal Disord. 2020;3(1):1–22.
   Google Scholar
• Yi Z, Rong G, Guan Y, et al. Molecular landscape and efficacy of HER2-targeted therapy in patients with HER2-mutated metastatic breast cancer. NPJ Breast Cancer. 2020;6(1):59–undefined.
   Web of Science ®Google Scholar
• Kanayama K, Imai H, Usugi E, Shiraishi T, Hirokawa YS, Watanabe M. Association of HER2 gene amplification and tumor progression in early gastric cancer. Virchows Archiv. 2018;473(5):559–565.
   Web of Science ®Google Scholar
• Leighl NB, Page RD, Raymond VM, et al. Clinical utility of comprehensive cell-free DNA analysis to identify genomic biomarkers in patients with newly diagnosed metastatic non–small cell lung cancer. Clin Cancer Res. 2019;25(15):4691–4700.
   PubMed Web of Science ®Google Scholar
• Seah DSE, Luis IV, Macrae E, et al. Use and duration of chemotherapy in patients with metastatic breast cancer according to tumor subtype and line of therapy. J Natl Compr Cancer Net. 2014;12(1):71–80.
   PubMed Web of Science ®Google Scholar
• Gatzemeier U, Groth G, Butts C, et al. Randomized phase II trial of gemcitabine–cisplatin with or without trastuzumab in HER2-positive non-small-cell lung cancer. Ann Oncol. 2004;15(1):19–27.
   PubMed Web of Science ®Google Scholar
• Lara PN, Laptalo L, Longmate J, et al. Trastuzumab plus docetaxel in HER2/neu–positive non–small-cell lung cancer: a California cancer consortium screening and Phase II trial. Clin Lung Cancer. 2004;5(4):231–236.
   PubMedGoogle Scholar
• Krug LM, Miller VA, Patel J, et al. Randomized phase II study of weekly docetaxel plus trastuzumab versus weekly paclitaxel plus trastuzumab in patients with previously untreated advanced nonsmall cell lung carcinoma. Cancer. 2005;104(10):2149–2155.
   PubMed Web of Science ®Google Scholar
• de Langen AJ, Jebbink M, Hashemi SMS, et al. Trastuzumab and paclitaxel in patients with EGFR mutated NSCLC that express HER2 after progression on EGFR TKI treatment. Br J Cancer. 2018;119(5):558–564.
   PubMed Web of Science ®Google Scholar
• Barthélémy P, Leblanc J, Goldbarg V, Wendling F, Kurtz J-E. Pertuzumab: development beyond breast cancer. Anticancer Res. 2014;34:1483–1491.
   PubMed Web of Science ®Google Scholar
• Agus DB, Gordon MS, Taylor C, et al. Phase I clinical study of pertuzumab, a novel HER dimerization inhibitor, in patients with advanced cancer. J Clin Oncol. 2005;23(11):2534–2543.
   PubMed Web of Science ®Google Scholar
• Herbst RS, Davies AM, Natale RB, et al. Efficacy and safety of single-agent pertuzumab, a human epidermal receptor dimerization inhibitor, in patients with non–small cell lung cancer. Clin Cancer Res. 2007;13(20):6175–6181.
   Web of Science ®Google Scholar
• Johnson BE, Jänne PA. Rationale for a Phase II trial of pertuzumab, a HER-2 dimerization inhibitor, in patients with non–small cell lung cancer: fig. 1. Clin Cancer Res. 2006;12(14):4436s–4440s.
   Web of Science ®Google Scholar
• Felip E, Ranson M, Cedrés S, et al. A Phase IB, dose-finding study of erlotinib in combination with a fixed dose of pertuzumab in patients with advanced non–small-cell lung cancer. Clin Lung Cancer. 2012;13(6):432–441.
   Web of Science ®Google Scholar
• Hughes B, Mileshkin L, Townley P, et al. Pertuzumab and erlotinib in patients with relapsed non‐small cell lung cancer: a Phase II study using 18F‐fluorodeoxyglucose positron emission tomography/computed tomography imaging. Oncologist. 2014;19(2):175–176.
   Web of Science ®Google Scholar
• Stinchcombe T, Stahel RA, Bubendorf L, et al. Efficacy, safety, and biomarker results of trastuzumab emtansine (T-DM1) in patients (pts) with previously treated HER2-overexpressing locally advanced or metastatic non-small cell lung cancer (mNSCLC). J Clin Oncol. 2017;35(15_suppl):8509.
   Web of Science ®Google Scholar
• Peters S, Stahel R, Bubendorf L, et al. Trastuzumab Emtansine (T-DM1) in patients with previously treated HER2-overexpressing metastatic non–small cell lung cancer: efficacy, safety, and biomarkers. Clin Cancer Res. 2019;25(1):64–72.
   PubMed Web of Science ®Google Scholar
• Hotta K, Aoe K, Kozuki T, et al. A Phase II study of trastuzumab emtansine in HER2-positive non–small cell lung cancer. J Thor Oncol. 2018;13(2):273–279.
   PubMed Web of Science ®Google Scholar
• Li BT, Shen R, Buonocore D, et al. Ado-trastuzumab emtansine for patients with HER2 -mutant lung cancers: results from a Phase II basket trial. J Clin Oncol. 2018;36(24):2532–2537.
   PubMed Web of Science ®Google Scholar
• Li BT, Michelini F, Misale S, et al. HER2-mediated internalization of cytotoxic agents in ERBB2 amplified or mutant lung cancers. Cancer Discov. 2020;10(5):674–687. doi:10.1158/2159-8290.CD-20-0215
   PubMed Web of Science ®Google Scholar
• Keam SJ. Trastuzumab deruxtecan: first approval. Drugs. 2020;80(5):501–508.
   PubMed Web of Science ®Google Scholar
• Modi S, Saura C, Yamashita T, et al. Trastuzumab deruxtecan in previously treated HER2-positive breast cancer. N Eng J Med. 2020;382(7):610–621.
   PubMed Web of Science ®Google Scholar
• Shitara K, Bang Y-J, Iwasa S, et al. Trastuzumab deruxtecan in previously treated HER2-positive gastric cancer. N Eng J Med. 2020;382(25):2419–2430.
   PubMed Web of Science ®Google Scholar
• Siena S, Di Bartolomeo M, Raghav K, et al. Trastuzumab deruxtecan (DS-8201) in patients with HER2-expressing metastatic colorectal cancer (DESTINY-CRC01): a multicentre, open-label, Phase 2 trial. Lancet Oncol. 2021;22(6):779–789.
   PubMed Web of Science ®Google Scholar
• Indini A, Rijavec E, Grossi F. Trastuzumab deruxtecan: changing the destiny of HER2 expressing solid tumors. Int J Mol Sci. 2021;22(9):4774.
   PubMed Web of Science ®Google Scholar
• Andrikopoulou A, Zografos E, Liontos M, Koutsoukos K, Dimopoulos M-A, Zagouri F. Trastuzumab deruxtecan (DS-8201a): the latest research and advances in breast cancer. Clin Breast Cancer. 2020.
   Web of Science ®Google Scholar
• Linehan AS, Fitzpatrick OM, Morris PG. Profile of Trastuzumab deruxtecan in the management of patients with HER2-positive unresectable or metastatic breast cancer: an evidence-based review. Breast Cancer. 2021;13:151–159.
   Web of Science ®Google Scholar
• Doi T, Shitara K, Naito Y, et al. Safety, pharmacokinetics, and antitumour activity of trastuzumab deruxtecan (DS-8201), a HER2-targeting antibody–drug conjugate, in patients with advanced breast and gastric or gastro-oesophageal tumours: a phase 1 dose-escalation study. Lancet Oncol. 2017;18(11):1512–1522.
   PubMed Web of Science ®Google Scholar
• Tamura K, Tsurutani J, Takahashi S, et al. Trastuzumab deruxtecan (DS-8201a) in patients with advanced HER2-positive breast cancer previously treated with trastuzumab emtansine: a dose-expansion, phase 1 study. Lancet Oncol. 2019;20(6):816–826.
   PubMed Web of Science ®Google Scholar
• Ogitani Y, Hagihara K, Oitate M, Naito H, Agatsuma T. Bystander killing effect of DS‐8201a, a novel anti‐human epidermal growth factor receptor 2 antibody–drug conjugate, in tumors with human epidermal growth factor receptor 2 heterogeneity. Cancer Sci. 2016;107(7):1039–1046.
   PubMed Web of Science ®Google Scholar
• Ogitani Y, Aida T, Hagihara K, et al. DS-8201a, A novel HER2-targeting ADC with a novel DNA topoisomerase i inhibitor, demonstrates a promising antitumor efficacy with differentiation from T-DM1. Clin Cancer Res. 2016;22(20):5097–5108.
   PubMed Web of Science ®Google Scholar
• Okamoto H, Oitate M, Hagihara K, et al. Pharmacokinetics of trastuzumab deruxtecan (T-DXd), a novel anti-HER2 antibody-drug conjugate, in HER2-positive tumour-bearing mice. Xenobiotica. 2020;50(10):1242–1250.
   PubMed Web of Science ®Google Scholar
• Nagai Y, Oitate M, Shiozawa H, Ando O. Comprehensive preclinical pharmacokinetic evaluations of trastuzumab deruxtecan (DS-8201a), a HER2-targeting antibody-drug conjugate, in cynomolgus monkeys. Xenobiotica. 2019;49(9):1086–1096.
   PubMed Web of Science ®Google Scholar
• Daiichi Sankyo Inc. Enhertu (Fam-Trastuzumab Deruxtecan-Nxki): US Prescribing Information; 2019.
   Google Scholar
• Takegawa N, Tsurutani J, Kawakami H, et al. [fam‐] trastuzumab deruxtecan, antitumor activity is dependent on HER2 expression level rather than on HER2 amplification. Int J Cancer. 2019;145(12):3414–3424.
   PubMed Web of Science ®Google Scholar
• Bartsch R. Trastuzumab-deruxtecan: an investigational agent for the treatment of HER2-positive breast cancer. Expert Opin Investig Drugs. 2020;29(9):901–910.
   PubMed Web of Science ®Google Scholar
• Takegawa N, Nonagase Y, Yonesaka K, et al. DS-8201a, a new HER2-targeting antibody-drug conjugate incorporating a novel DNA topoisomerase I inhibitor, overcomes HER2-positive gastric cancer T-DM1 resistance. Int J Cancer. 2017;141(8):1682–1689.
   PubMed Web of Science ®Google Scholar
• Tsurutani J, Iwata H, Krop I, et al. Targeting HER2 with trastuzumab deruxtecan: a dose-expansion, Phase I Study in multiple advanced solid tumors. Cancer Discov. 2020;10:5.
   Web of Science ®Google Scholar
• Smit EF, Nakagawa K, Nagasaka M, et al. Trastuzumab deruxtecan (T-DXd; DS-8201) in patients with HER2-mutated metastatic non-small cell lung cancer (NSCLC): interim results of DESTINY-Lung01. J Clin Oncol. 2020;38(15_suppl):9504.
   Google Scholar
• Horvath L, Pircher A. ASCO 2020 non-small lung cancer (NSCLC) personal highlights. Magazine Eur Med Oncol. 2021;14(1):66–69.
   Google Scholar
• Nakagawa K, Nagasaka M, Felip E, et al. OA04.05 trastuzumab deruxtecan in HER2-overexpressing metastatic non-small cell lung cancer: interim results of DESTINY-Lung01. J Thor Oncol. 2021;16:3.
   Web of Science ®Google Scholar
• Modi S, Park H, Murthy RK, et al. Antitumor activity and safety of trastuzumab deruxtecan in patients with HER2-low–expressing advanced breast cancer: results from a Phase IB Study. J Clin Oncol. 2020;38(17):1887–1896.
   PubMed Web of Science ®Google Scholar
• Borghaei H, Besse B, Bardia A, et al. Trastuzumab deruxtecan (T-DXd; DS-8201) in combination with pembrolizumab in patients with advanced/metastatic breast or non-small cell lung cancer (NSCLC): a phase Ib, multicenter, study. J Clin Oncol. 2020;38(15_suppl):TPS1100–TPS1100.
   Web of Science ®Google Scholar
• Planchard D, Yang JC-H, Brahmer JR, et al. 185TiP A phase Ib dose-escalation study evaluating trastuzumab deruxtecan (T-DXd) and durvalumab in combination with chemotherapy as first-line treatment in patients with advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) and HER2 overexpression (DESTINY-Lung03. J Thor Oncol. 2021;16:4.
   Web of Science ®Google Scholar
• Garon EB, Ciuleanu TE, Arrieta O, et al. Ramucirumab plus docetaxel versus placebo plus docetaxel for second-line treatment of stage IV non-small-cell lung cancer after disease progression on platinum-based therapy (REVEL): a multicentre, double-blind, randomised Phase 3 trial. Lancet. 2014;384(9944):665–673.
   PubMed Web of Science ®Google Scholar
• Yagisawa M, Nakamura Y, Yoshino T, et al. A basket trial of trastuzumab deruxtecan, a HER2-targeted antibody-drug conjugate, for HER2-amplified solid tumors identified by circulating tumor DNA analysis (HERALD trial). J Clin Oncol. 2020;38(15_suppl):TPS3650–TPS3650.
   Web of Science ®Google Scholar
• Elamin Y, Robichaux J, Lam V, et al. OA 12.01 the preclinical and clinical activity of poziotinib, a potent, selective inhibitor of EGFR Exon 20 mutant NSCLC. J Thor Oncol. 2017;12(11):S1776–undefined.
   Web of Science ®Google Scholar
• Heymach J, Negrao M, Robichaux J, et al. OA02.06 a phase II trial of poziotinib in EGFR and HER2 exon 20 mutant Non-Small Cell Lung Cancer (NSCLC). J Thor Oncol. 2018;13(10):S323–S324.
   PubMed Web of Science ®Google Scholar
• Le X, Goldman J, Clarke J, et al. Abstract CT081: poziotinib activity and durability of responses in previously treated EGFR exon 20 NSCLC patients - a Phase 2 study. Cancer Res. 2020;80(16 Supplement):CT081 LP–CT081.
   Web of Science ®Google Scholar
• Robichaux JP, Elamin YY, Vijayan RSK, et al. Pan-cancer landscape and analysis of ERBB2 mutations identifies poziotinib as a clinically active inhibitor and enhancer of T-DM1 activity. Cancer Cell. 2019;36:4.
   Web of Science ®Google Scholar
• Liu SV, Villaruz LC, Lee VHF, et al. LBA61 First analysis of RAIN-701: study of tarloxotinib in patients with non-small cell lung cancer (NSCLC) EGFR Exon 20 insertion, HER2-activating mutations & other solid tumours with NRG1/ERBB gene fusions. Ann Oncol. 2020;31:S1189–undefined.
   Web of Science ®Google Scholar