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The Development of Immuno-oncology Therapy and the Biomarker Research |
Zhen-hu LI,Yun-fei WU,Ying PAN,Zhao-xiang REN,Xiang-chao GU,Liang TANG,Xin-zhong WANG,Juan ZHANG() |
Cstone Pharmaceuticals (Su Zhou) Co., Ltd. Suzhou 215123, China |
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Abstract Due to the development of immunology and oncology, and their cross infiltration and integration, immuno-oncology (IO) has gradually become a innovative hot area, which shed new light on cancer therapy. IO therapies fight tumors through activating or normalizing the body’s immune system, such as T cells, NK cells, etc., aiming to achieve disease remission or cure.. Along with the in-depth research, a variety of new IO therapy drugs have been approved and showed the unprecedented universality in a spectrum of cancer types. However, improving patient response rate is still a critical issue in the field. This article will analyze the opportunities and challenges in the process of IO therapy development from the perspectives of new IO target discovery, the combination strategy and the application of biomarkers.
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Received: 10 January 2019
Published: 26 March 2019
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[1] |
Kirkwood J M, Tarhini A A, Panelli M C , et al. Next generation of immunotherapy for melanoma. J Clin Oncol, 2008,26(20):3445-3455.
doi: 10.1200/JCO.2007.14.6423
pmid: 18612161
|
|
|
[2] |
Balkwill F, Mantovani A .( Inflammation and cancer: back to virchow? Lancet, 2001,357(9255):539-545.
doi: 10.1016/S0140-6736(00)04046-0
|
|
|
[3] |
Felgner S, Kocijancic D, Frahm M , et al. Bacteria in cancer therapy: renaissance of an old concept. Int J Microbiol, 2016,2016:8451728.
doi: 10.1155/2016/8451728
pmid: 27051423
|
|
|
[4] |
Kim R, Emi M, Tanabe K . Cancer immunoediting from immune surveillance to immune escape. Immunology, 2007,121(1):1-14.
doi: 10.1111/j.1365-2567.2007.02587.x
pmid: 17386080
|
|
|
[5] |
Steinman R M, Cohn Z A . Identification of a novel cell type in peripheral lymphoid organs of mice. I. Morphology, quantitation, tissue distribution. J Exp Med, 1973,137(5):1142-1162.
doi: 10.1084/jem.137.5.1142
|
|
|
[6] |
Zinkernagel R M, Doherty P C . Immunological surveillance against altered self components by sensitised T lymphocytes in lymphocytic choriomeningitis. Nature, 1974,251(5475):547-548.
doi: 10.1038/251547a0
pmid: 4547543
|
|
|
[7] |
Bevan M J . Cross-priming for a secondary cytotoxic response to minor H antigens with H-2 congenic cells which do not cross-react in the cytotoxic assay. J Exp Med, 1976,143(5):1283-1288.
doi: 10.1084/jem.143.5.1283
pmid: 1083422
|
|
|
[8] |
Lotze M T, Chang A E, Seipp C A , et al. High-dose recombinant interleukin 2 in the treatment of patients with disseminated cancer. Responses, treatment-related morbidity, and histologic findings. JAMA, 1986,256(22):3117-3124.
doi: 10.1001/jama.1986.03380220083027
|
|
|
[9] |
Payne R, Glenn L, Hoen H , et al. Durable responses and reversible toxicity of high-dose interleukin-2 treatment of melanoma and renal cancer in a Community Hospital Biotherapy Program. J Immunother Cancer, 2014,2:13.
doi: 10.1186/2051-1426-2-13
pmid: 24855563
|
|
|
[10] |
Boyiadzis M, Foon K A . Approved monoclonal antibodies for cancer therapy. Expert Opin Biol Ther, 2008,8(8):1151-1158.
doi: 10.1517/14712598.8.8.1151
pmid: 18613766
|
|
|
[11] |
Sharma P, Allison J P . The future of immune checkpoint therapy. Science, 2015,348(6230):56-61.
doi: 10.1126/science.aaa8172
|
|
|
[12] |
Hazarika M, Chuk M K, Theoret M R , et al. U.S. FDA approval summary: nivolumab for treatment of unresectable or metastatic melanoma following progression on ipilimumab. Clin Cancer Res, 2017,23(14):3484-3488.
doi: 10.1158/1078-0432.CCR-16-0712
pmid: 28087644
|
|
|
[13] |
Tang J, Shalabi A , Hubbard-Lucey V M. Comprehensive analysis of the clinical immuno-oncology landscape. Ann Oncol, 2018,29(1):84-91.
doi: 10.1093/annonc/mdx755
pmid: 29228097
|
|
|
[14] |
Mahoney K M, Rennert P D, Freeman G J . Combination cancer immunotherapy and new immunomodulatory targets. Nat Rev Drug Discov, 2015,14(8):561-584.
doi: 10.1038/nrd4591
pmid: 26228759
|
|
|
[15] |
Chen D S, Mellman I . Oncology meets immunology: the cancer-immunity cycle. Immunity, 2013,39(1):1-10.
doi: 10.1016/j.immuni.2013.07.012
|
|
|
[16] |
Lipson E J, Forde P M, Hammers H J , et al. Antagonists of PD-1 and PD-L1 in cancer treatment. Semin Oncol, 2015,42(4):587-600.
doi: 10.1053/j.seminoncol.2015.05.013
|
|
|
[17] |
Emens L A, Ascierto P A, Darcy P K , et al. Cancer immunotherapy: Opportunities and challenges in the rapidly evolving clinical landscape. Eur J Cancer, 2017,81:116-129.
doi: 10.1016/j.ejca.2017.01.035
pmid: 28623775
|
|
|
[18] |
Wolchok J D, Chiarion-Sileni V, Gonzalez R , et al. Overall survival with combined nivolumab and ipilimumab in advanced melanoma. N Engl J Med, 2017,377(14):1345-1356.
doi: 10.1056/NEJMoa1709684
pmid: 28889792
|
|
|
[19] |
Chen, D S , Mellman I. Elements of cancer immunity and the cancer-immune set point. Nature, 2017,541(7637):321-330.
doi: 10.1038/nature21349
pmid: 28102259
|
|
|
[20] |
Burugu S, Dancsok A R, Nielsen T O . Emerging targets in cancer immunotherapy. Semin Cancer Biol, 2018,52(Pt 2):39-52.
doi: 10.1016/j.semcancer.2017.10.001
pmid: 28987965
|
|
|
[21] |
Huang R Y, Francois A , McGray A R, et al. Compensatory upregulation of PD-1, LAG-3, and CTLA-4 limits the efficacy of single-agent checkpoint blockade in metastatic ovarian cancer. Oncoimmunology, 2016,6(1):e1249561.
|
|
|
[22] |
Shayan G, Srivastava R, Li J , et al. Adaptive resistance to anti-PD1 therapy by Tim-3 upregulation is mediated by the PI3K-Akt pathway in head and neck cancer. Oncoimmunology, 2016,6(1):e1261779.
doi: 10.1080/2162402X.2016.1261779
pmid: 28197389
|
|
|
[23] |
Deuss F A, Gully B S, Rossjohn J , et al. Recognition of nectin-2 by the natural killer cell receptor T cell immunoglobulin and ITIM domain (TIGIT). J Biol Chem, 2017,292(27):11413-11422.
doi: 10.1074/jbc.M117.786483
pmid: 28515320
|
|
|
[24] |
B?ger C, Behrens H M, Krüger S , et al. The novel negativecheckpointregulator VISTA is expressed in gastric carcinoma and associated with PD-L1/PD-1: A future perspective for a combined gastric cancer therapy? Oncoimmunology, 2017,6(4):e1293215.
doi: 10.1080/2162402X.2017.1293215
pmid: 5414883
|
|
|
[25] |
Beatty G L , O’Dwyer P J, Clark J, et al. First-in-human phase I study of the oral inhibitor of indoleamine 2,3-dioxygenase-1 epacadostat (INCB024360) in patients with advanced solid malignancies. Clin Cancer Res, 2017,23(13):3269-3276.
doi: 10.1158/1078-0432.CCR-16-2272
pmid: 28053021
|
|
|
[26] |
Brignone C, Gutierrez M, Mefti F , et al. First-line chemoimmunotherapy in metastatic breast carcinoma: combination of paclitaxel and IMP321 (LAG-3Ig) enhances immune responses and antitumor activity. J Transl Med, 2010,8:71.
doi: 10.1186/1479-5876-8-71
pmid: 20653948
|
|
|
[27] |
Dougall W C, Kurtulus S, Smyth M J , et al. TIGIT and CD96: new checkpoint receptor targets for cancer immunotherapy. Immunol Rev, 2017,276(1):112-120.
doi: 10.1111/imr.12518
pmid: 28258695
|
|
|
[28] |
Liu J, Wang L, Zhao F , et al. Pre-clinical development of a humanized anti-CD47 antibody with anti-cancer therapeutic potential. PLoS One, 2015,10(9):e0137345.
doi: 10.1371/journal.pone.0137345
pmid: 26390038
|
|
|
[29] |
Gibney G T, Weiner L M, Atkins M B . Predictive biomarkers for checkpoint inhibitor-based immunotherapy. Lancet Oncol, 2016,17(12):e542-e551.
doi: 10.1016/S1470-2045(16)30406-5
pmid: 27924752
|
|
|
[30] |
Savic Prince S, Bubendorf L . Predictive potential and need for standardization of PD-L1 immunohistochemistry. World J Urol, 2018.
doi: 10.1007/s00428-018-2445-7
|
|
|
[31] |
Meng X, Huang Z, Teng F , et al. Predictive biomarkers in PD-1/PD-L1 checkpoint blockade immunotherapy. Cancer Treat Rev, 2015,41(10):868-876.
doi: 10.1016/j.ctrv.2015.11.001
pmid: 26589760
|
|
|
[32] |
Garon E B, Rizvi N A, Hui R , et al. Pembrolizumab for the treatment of non-small-cell lung cancer. N Engl J Med, 2015,372(21):2018-2028.
doi: 10.1056/NEJMoa1501824
pmid: 25891174
|
|
|
[33] |
Hirsch F R , McElhinny A, Stanforth D, et al. PD-L1 immunohistochemistry assays for lung cancer: Results from phase 1 of the blueprint PD-L1 IHC assay comparison project. J Thorac Oncol, 2017,12(2):208-222.
doi: 10.1016/j.jtho.2016.11.2228
pmid: 27913228
|
|
|
[34] |
Marianne J R, Alan S, Anita M , et al. Agreement between programmed cell death ligand-1 diagnostic assays across multiple protein expression cut-offs in non-small cell lung cancer. Clinical Cancer Research An Official Journal of the American Association for Cancer Research, 2017,23(14):3585.
doi: 10.1158/1078-0432.CCR-16-2375
pmid: 28073845
|
|
|
[35] |
Topalian S L, Taube J M, Anders R A , et al. Mechanism-driven biomarkers to guide immune checkpoint blockade in cancer therapy. Nat Rev Cancer, 2016,16(5):275-287.
doi: 10.1038/nrc.2016.36
|
|
|
[36] |
Pitt J M, Vétizou M, Daillère R , et al. Resistance mechanisms to immune-checkpoint blockade in cancer: Tumor-intrinsic and -Extrinsic Factors. Immunity, 2016,44(6):1255-1269.
doi: 10.1016/j.immuni.2016.06.001
|
|
|
[37] |
Sharma P, Hu-Lieskovan S, Wargo J A , et al. Primary, Adaptive, and Acquired Resistance to Cancer Immunotherapy. Cell, 2017,168(4):707-723.
doi: 10.1016/j.cell.2017.01.017
pmid: 28187290
|
|
|
[38] |
Yarchoan M, Hopkins A, Jaffee E M . Tumor mutational burden and response rate to PD-1 inhibition. N Engl J Med, 2017,377(25):2500-2501.
doi: 10.1056/NEJMc1713444
pmid: 29262275
|
|
|
[39] |
Dubsky P C, Fesl C, Singer C F , et al. Abstract GS6-04: The endopredict score predicts residual cancer burden after neoadjuvant chemotherapy and after neoendocrince therapy in HR+/HER2- breast cancer patients from ABCSG 34. Journal of Clinical Oncology, 2018,36(15suppl):589-589.
|
|
|
[40] |
Rizvi N A, Hellmann M D, Snyder A , et al. Mutational landscape determines sensitivity to PD-1 blockade in non-small cell lung cancer. Science, 2015,348(6230):124-128.
doi: 10.1126/science.aaa1348
pmid: 25765070
|
|
|
[41] |
Hellmann M D, Ciuleanu T E, Pluzanski A , et al. Nivolumab plus ipilimumab in lung cancer with a high tumor mutational burden. N Engl J Med, 2018,378(22):2093-2104.
doi: 10.1056/NEJMoa1801946
pmid: 29658845
|
|
|
[42] |
Boyiadzis M M, Kirkwood J M, Marshall J L , et al. Significance and implications of FDA approval of pembrolizumab for biomarker-defined disease. J Immunother Cancer, 2018,6(1):35.
doi: 10.1186/s40425-018-0342-x
pmid: 29754585
|
|
|
[43] |
FDA approves first cancer treatment for any solid tumor with a specific genetic feature. Oncology Times.[2017-05-23].
|
|
|
[44] |
Le D T, Durham J N, Smith K N , et al. Mismatch repair deficiency predicts response of solid tumors to PD-1 blockade. Science, 2017,357(6349):409-413.
doi: 10.1126/science.aan6733
pmid: 5576142
|
|
|
[45] |
Dudley J C, Lin M T, Le D T , et al. Microsatellite instability as a biomarker for PD-1 blockade. Clin Cancer Res, 2016,22(4):813-820.
doi: 10.1158/1078-0432.CCR-15-1678
pmid: 26880610
|
|
|
[46] |
Chalmers Z R, Connelly C F, Fabrizio D , et al. Analysis of 100,000 human cancer genomes reveals the landscape of tumor mutational burden. Genome Med, 2017,9(1):34.
doi: 10.1186/s13073-017-0424-2
pmid: 5395719
|
|
|
[47] |
Higgs B W, Morehouse C A, Streicher K , et al. Interferon gamma messenger RNA signature in tumor biopsies predicts outcomes in patients with non-small-cell lung carcinoma or urothelial cancer treated with durvalumab. Clin Cancer Res, 2018,24(16):3857-3866.
doi: 10.1158/1078-0432.CCR-17-3451
pmid: 29716923
|
|
|
[48] |
Ayers M, Lunceford J, Nebozhyn M , et al. IFN-γ-related mRNA profile predicts clinical response to PD-1 blockade.[J] Clin Invest. 2017,127(8):2930-2940.
doi: 10.1172/JCI91190
|
|
|
[49] |
Cristescu R, Mogg R, Ayers M , et al. Pan-tumor genomic biomarkers for PD-1 checkpoint blockade-based immunotherapy. Science, 2018, 362(6411):eaar3593.
|
|
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