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Review

Emerging monoclonal antibody therapy for head and neck squamous cell carcinoma

&
Received 21 Dec 2023, Accepted 03 Apr 2024, Published online: 15 Apr 2024

References

  • Sung H, Ferlay J, Siegel RL, et al. Global cancer statistics 2020: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2021 May;71(3):209–249.
  • Lechner M, Liu J, Masterson L, et al. HPV-associated oropharyngeal cancer: epidemiology, molecular biology and clinical management. Nat Rev Clin Oncol. 2022 May;19(5):306–327.
  • de Martel C, Plummer M, Vignat J, et al. Worldwide burden of cancer attributable to HPV by site, country and HPV type. Int J Cancer. 2017 Aug 15;141(4):664–670. doi: 10.1002/ijc.30716
  • Kreimer AR, Clifford GM, Boyle P, et al. Human papillomavirus types in head and neck squamous cell carcinomas worldwide: a systematic review. Cancer Epidemiol Biomarkers Prev. 2005 Feb;14(2):467–475.
  • Lei J, Ploner A, Elfström KM, et al. HPV vaccination and the risk of invasive cervical cancer. N Engl J Med. 2020 Oct 1;383(14):1340–1348. doi: 10.1056/NEJMoa1917338
  • Schernberg A, Sagaon-Teyssier L, Schwarzinger M. Clinical and economic burden of head and neck cancer: a nationwide retrospective cohort study from France. Clinicoecon Outcomes Res. 2019;11:441–451. doi: 10.2147/CEOR.S198312
  • Johnson DE, Burtness B, Leemans CR, et al. Head and neck squamous cell carcinoma. Nat Rev Dis Primers. 2020 Nov 26;6(1):92. doi: 10.1038/s41572-020-00224-3
  • Kriegs M, Clauditz TS, Hoffer K, et al. Analyzing expression and phosphorylation of the EGF receptor in HNSCC. Sci Rep. 2019 Sep 19;9(1):13564. doi: 10.1038/s41598-019-49885-5
  • Scheffner M, Werness BA, Huibregtse JM, et al. The E6 oncoprotein encoded by human papillomavirus types 16 and 18 promotes the degradation of p53. Cell. 1990 Dec 21;63(6):1129–1136. doi: 10.1016/0092-8674(90)90409-8
  • Dyson N, Howley PM, Münger K, et al. The human papilloma virus-16 E7 oncoprotein is able to bind to the retinoblastoma gene product. Science. 1989 Feb 17;243(4893):934–937. doi: 10.1126/science.2537532
  • Stavrou S, Ross SR. APOBEC3 Proteins in Viral Immunity. J Immunol. 2015 Nov 15;195(10):4565–4570. doi: 10.4049/jimmunol.1501504
  • Henderson S, Chakravarthy A, Su X, et al. APOBEC-mediated cytosine deamination links PIK3CA helical domain mutations to human papillomavirus-driven tumor development. Cell Rep. 2014 Jun 26;7(6):1833–1841. doi: 10.1016/j.celrep.2014.05.012
  • Gillison ML, Akagi K, Xiao W, et al. Human papillomavirus and the landscape of secondary genetic alterations in oral cancers. Genome Res. 2019 Jan;29(1):1–17.
  • Hanahan D, Weinberg RA. Hallmarks of cancer: the next generation. Cell. 2011 Mar 4;144(5):646–674. doi: 10.1016/j.cell.2011.02.013
  • Welters MJP, Ma W, Santegoets S, et al. Intratumoral HPV16-specific T cells constitute a type I-oriented tumor microenvironment to improve survival in hpv16-driven oropharyngeal cancer. Clin Cancer Res. 2018 Feb 1;24(3):634–647. doi: 10.1158/1078-0432.CCR-17-2140
  • Muranski P, Boni A, Antony PA, et al. Tumor-specific Th17-polarized cells eradicate large established melanoma. Blood. 2008 Jul 15;112(2):362–373. doi: 10.1182/blood-2007-11-120998
  • Muranski P, Restifo NP. Adoptive immunotherapy of cancer using CD4(+) T cells. Curr Opin Immunol. 2009 Apr;21(2):200–208. doi: 10.1016/j.coi.2009.02.004
  • Wusiman D, Guo L, Huang Z, et al. The clinicopathological significance of PD-L1 expression assessed by the combined positive score (CPS) in head and neck squamous cell carcinoma. Pathol Res Pract. 2022 Aug;236:153934. doi: 10.1016/j.prp.2022.153934
  • Hong AM, Ferguson P, Dodds T, et al. Significant association of PD-L1 expression with human papillomavirus positivity and its prognostic impact in oropharyngeal cancer. Oral Oncol. 2019 May;92:33–39. doi: 10.1016/j.oraloncology.2019.03.012
  • Carretero M, Cantoni C, Bellón T, et al. The CD94 and NKG2-A C-type lectins covalently assemble to form a natural killer cell inhibitory receptor for HLA class I molecules. Eur J Immunol. 1997 Feb;27(2):563–567.
  • Vokes EE, Athanasiadis I. Chemotherapy of squamous cell carcinoma of head and neck: the future is now. Ann Oncol. 1996 Jan;7(1):15–29. doi: 10.1093/oxfordjournals.annonc.a010467
  • Zhu X, Zhang F, Zhang W, et al. Prognostic role of epidermal growth factor receptor in head and neck cancer: a meta-analysis. J Surg Oncol. 2013 Nov;108(6):387–397.
  • Vermorken JB, Trigo J, Hitt R, et al. Open-label, uncontrolled, multicenter phase II study to evaluate the efficacy and toxicity of cetuximab as a single agent in patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck who failed to respond to platinum-based therapy. J Clin Oncol. 2007 Jun 1;25(16):2171–2177. doi: 10.1200/JCO.2006.06.7447
  • Vermorken JB, Mesia R, Rivera F, et al. Platinum-based chemotherapy plus cetuximab in head and neck cancer. N Engl J Med. 2008 Sep 11;359(11):1116–1127. doi: 10.1056/NEJMoa0802656
  • Vermorken JB, Remenar E, Hitt R, et al. Platinum-based chemotherapy (CT) plus cetuximab in recurrent or metastatic squamous cell carcinoma of the head and neck cancer (R/M-SCCHN): 5-year follow-up data for the extreme trial. J Clin Oncol. 2014;32(15_suppl):6021–6021. doi: 10.1200/jco.2014.32.15_suppl.6021
  • Licitra L, Mesia R, Rivera F, et al. Evaluation of EGFR gene copy number as a predictive biomarker for the efficacy of cetuximab in combination with chemotherapy in the first-line treatment of recurrent and/or metastatic squamous cell carcinoma of the head and neck: EXTREME study. Ann Oncol. 2011 May;22(5):1078–1087.
  • Bonner JA, Mesia R, Giralt J, et al. p16, HPV, and cetuximab: what is the evidence? Oncology. 2017 Jul;22(7):811–822.
  • Vermorken JB, Stöhlmacher-Williams J, Davidenko I, et al. Cisplatin and fluorouracil with or without panitumumab in patients with recurrent or metastatic squamous-cell carcinoma of the head and neck (SPECTRUM): an open-label phase 3 randomised trial. Lancet Oncol. 2013 Jul;14(8):697–710.
  • Argiris A, Ghebremichael M, Gilbert J, et al. Phase III randomized, placebo-controlled trial of docetaxel with or without gefitinib in recurrent or metastatic head and neck cancer: an eastern cooperative oncology group trial. J Clin Oncol. 2013 Apr 10;31(11):1405–1414. doi: 10.1200/JCO.2012.45.4272
  • de Souza JA, Davis DW, Zhang Y, et al. A phase II study of lapatinib in recurrent/metastatic squamous cell carcinoma of the head and neck. Clin Cancer Res. 2012 Apr 15;18(8):2336–2343. doi: 10.1158/1078-0432.CCR-11-2825
  • Soulieres D, Senzer NN, Vokes EE, et al. Multicenter phase II study of Erlotinib, an oral epidermal growth factor receptor tyrosine kinase inhibitor, in patients with recurrent or metastatic squamous cell cancer of the head and neck. J Clin Oncol. 2004;22(1):77–85. doi: 10.1200/JCO.2004.06.075
  • Machiels JP, Haddad RI, Fayette J, et al. Afatinib versus methotrexate as second-line treatment in patients with recurrent or metastatic squamous-cell carcinoma of the head and neck progressing on or after platinum-based therapy (LUX-Head & Neck 1): an open-label, randomised phase 3 trial. Lancet Oncol. 2015 May;16(5):583–594.
  • Abdul Razak AR, Soulières D, Laurie SA, et al. A phase II trial of dacomitinib, an oral pan-human EGF receptor (HER) inhibitor, as first-line treatment in recurrent and/or metastatic squamous-cell carcinoma of the head and neck. Ann Oncol. 2013 Mar;24(3):761–769.
  • Wang Z, Valera JC, Zhao X, et al. mTOR co-targeting strategies for head and neck cancer therapy. Cancer Metastasis Rev. 2017 Sep;36(3):491–502.
  • Comprehensive genomic characterization of head and neck squamous cell carcinomas. Nature. 2015 Jan 29;517(7536):576–582. doi: 10.1038/nature14129
  • Cohen EEW, Soulières D, Le Tourneau C, et al. Pembrolizumab versus methotrexate, docetaxel, or cetuximab for recurrent or metastatic head-and-neck squamous cell carcinoma (KEYNOTE-040): a randomised, open-label, phase 3 study. Lancet. 2019 Jan 12;393(10167):156–167. doi: 10.1016/S0140-6736(18)31999-8
  • Ferris RL, Blumenschein G Jr., Fayette J, et al. Nivolumab for recurrent squamous-cell carcinoma of the head and neck. N Engl J Med. 2016 Nov 10;375(19):1856–1867. doi: 10.1056/NEJMoa1602252
  • Burtness B, Harrington KJ, Greil R, et al. Pembrolizumab alone or with chemotherapy versus cetuximab with chemotherapy for recurrent or metastatic squamous cell carcinoma of the head and neck (KEYNOTE-048): a randomised, open-label, phase 3 study. Lancet. 2019 Nov 23;394(10212):1915–1928. doi: 10.1016/S0140-6736(19)32591-7
  • Harrington KJ, Burtness B, Greil R, et al. Pembrolizumab with or without chemotherapy in recurrent or metastatic head and neck squamous cell carcinoma: updated results of the phase III KEYNOTE-048 study. J Clin Oncol. 2023 Feb 1;41(4):790–802. doi: 10.1200/JCO.21.02508
  • Tahara M, Greil R, Rischin D, et al. 659MO Pembrolizumab with or without chemotherapy for first-line treatment of recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC): 5-year results from KEYNOTE-048. Ann Oncol. 2022;33:S844. doi: 10.1016/j.annonc.2022.07.783
  • Carter BW, Bhosale PR, Yang WT. Immunotherapy and the role of imaging. Cancer. 2018 Jul 15;124(14):2906–2922. doi: 10.1002/cncr.31349
  • Wolchok JD, Chiarion-Sileni V, Gonzalez R, et al. Overall survival with combined nivolumab and ipilimumab in advanced melanoma. N Engl J Med. 2017 Oct 5;377(14):1345–1356. doi: 10.1056/NEJMoa1709684
  • Haddad RI, Harrington K, Tahara M, et al. Nivolumab plus ipilimumab versus EXTREME regimen as first-line treatment for recurrent/metastatic squamous cell carcinoma of the head and neck: the final results of checkmate 651. J Clin Oncol. 2023 Apr 20;41(12):2166–2180. doi: 10.1200/JCO.22.00332
  • Psyrri A, Fayette J, Harrington K, et al. Durvalumab with or without tremelimumab versus the EXTREME regimen as first-line treatment for recurrent or metastatic squamous cell carcinoma of the head and neck: KESTREL, a randomized, open-label, phase III study. Ann Oncol. 2023 Mar;34(3):262–274. doi: 10.1016/j.annonc.2022.12.008
  • Head and neck squamous cell carcinomma (hnscc) market size & share, by drug class (immunotherapy, chemotherapy, Targeted Therapy) - Global Sypply & Demand Analysiis, Growth Forecasts, Statistics Report 2023-2035. 2023 [cited 2023 Dec 13]. Available from: https://www.researchnester.com/reports/head-and-neck-squamous-cell-carcinoma-treatment-and-drugs-market/2839
  • Burtness B, Rischin D, Greil R, et al. Pembrolizumab alone or with chemotherapy for recurrent/metastatic head and neck squamous cell carcinoma in keynote-048: Subgroup Analysis by Programmed Death Ligand-1 Combined Positive Score. J Clin Oncol. 2022 Jul 20;40(21):2321–2332. doi: 10.1200/JCO.21.02198
  • Trivedi S, Srivastava RM, Concha-Benavente F, et al. Anti-EGFR targeted monoclonal antibody isotype influences antitumor cellular immunity in head and neck cancer patients. Clin Cancer Res. 2016 Nov 1;22(21):5229–5237. doi: 10.1158/1078-0432.CCR-15-2971
  • Lee SC, Srivastava RM, López-Albaitero A, et al. Natural killer (NK): dendritic cell (DC) cross talk induced by therapeutic monoclonal antibody triggers tumor antigen-specific T cell immunity. Immunol Res. 2011 Aug;50(2–3):248–254.
  • Srivastava RM, Lee SC, Andrade Filho PA, et al. Cetuximab-activated natural killer and dendritic cells collaborate to trigger tumor antigen-specific T-cell immunity in head and neck cancer patients. Clin Cancer Res. 2013 Apr 1;19(7):1858–1872. doi: 10.1158/1078-0432.CCR-12-2426
  • Peruzzi B, Bottaro DP. Targeting the c-Met signaling pathway in cancer. Clin Cancer Res. 2006 Jun 15;12(12):3657–3660. doi: 10.1158/1078-0432.CCR-06-0818
  • Knowles LM, Stabile LP, Egloff AM, et al. HGF and c-Met participate in paracrine tumorigenic pathways in head and neck squamous cell cancer. Clin Cancer Res. 2009 Jun 1;15(11):3740–3750. doi: 10.1158/1078-0432.CCR-08-3252
  • Bauman JE, Ohr J, Gooding WE, et al. Phase I study of ficlatuzumab and cetuximab in cetuximab-resistant, recurrent/metastatic head and neck cancer. Cancers (Basel). 2020 Jun 11;12(6):1537. doi: 10.3390/cancers12061537
  • Wu Z, Song W, Cheng Z, et al. Expression of LGR5 in oral squamous cell carcinoma and its correlation to vasculogenic mimicry. Int J Clin Exp Pathol. 2017;10(11):11267–11275.
  • Saba NF, Vijayvargiya P, Vermorken JB, et al. Targeting angiogenesis in squamous cell carcinoma of the head and neck: opportunities in the immunotherapy era. Cancers (Basel). 2022 Feb 25;14(5):1202. doi: 10.3390/cancers14051202
  • Ziogas AC, Gavalas NG, Tsiatas M, et al. VEGF directly suppresses activation of T cells from ovarian cancer patients and healthy individuals via VEGF receptor Type 2. Int J Cancer. 2012 Feb 15;130(4):857–864. doi: 10.1002/ijc.26094
  • Hansen W, Hutzler M, Abel S, et al. Neuropilin 1 deficiency on CD4+Foxp3+ regulatory T cells impairs mouse melanoma growth. J Exp Med. 2012 Oct 22;209(11):2001–2016. doi: 10.1084/jem.20111497
  • Lee JY, Park S, Min WS, et al. Restoration of natural killer cell cytotoxicity by VEGFR-3 inhibition in myelogenous leukemia. Cancer Lett. 2014 Nov 28;354(2):281–289. doi: 10.1016/j.canlet.2014.08.027
  • Voron T, Colussi O, Marcheteau E, et al. VEGF-A modulates expression of inhibitory checkpoints on CD8+ T cells in tumors. J Exp Med. 2015 Feb 9;212(2):139–148. doi: 10.1084/jem.20140559
  • Licitra L, Tahara M, Harrington K, et al. Pembrolizumab with or without lenvatinib as first-line therapy for recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC): phase 3 LEAP-010 study. Int J Radiat Oncol Biol Phys. 2024;118(5):e2–e3. doi: 10.1016/j.ijrobp.2024.01.016
  • Monney L, Sabatos CA, Gaglia JL, et al. Th1-specific cell surface protein Tim-3 regulates macrophage activation and severity of an autoimmune disease. Nature. 2002 Jan 31;415(6871):536–541. doi: 10.1038/415536a
  • Davar D, Zarour HM. Immunological targets for immunotherapy: inhibitory T cell receptors. Methods Mol Biol. 2020;2055:23–60.
  • Koyama S, Akbay EA, Li YY, et al. Adaptive resistance to therapeutic PD-1 blockade is associated with upregulation of alternative immune checkpoints. Nat Commun. 2016 Feb 17;7(1):10501. doi: 10.1038/ncomms10501
  • Chauvin JM, Zarour HM. TIGIT in cancer immunotherapy. J Immunother Cancer. 2020 Sep;8(2):e000957. doi: 10.1136/jitc-2020-000957
  • Johnston RJ, Comps-Agrar L, Hackney J, et al. The immunoreceptor TIGIT regulates antitumor and antiviral CD8(+) T cell effector function. Cancer Cell. 2014 Dec 8;26(6):923–937. doi: 10.1016/j.ccell.2014.10.018
  • Zhang Q, Bi J, Zheng X, et al. Blockade of the checkpoint receptor TIGIT prevents NK cell exhaustion and elicits potent anti-tumor immunity. Nat Immunol. 2018 Jul;19(7):723–732.
  • Tawbi HA, Schadendorf D, Lipson EJ, et al. Relatlimab and Nivolumab versus Nivolumab in Untreated Advanced Melanoma. N Engl J Med. 2022 Jan 6;386(1):24–34. doi: 10.1056/NEJMoa2109970
  • Choi Y, Shi Y, Haymaker CL, et al. T-cell agonists in cancer immunotherapy. J Immunother Cancer. 2020 Oct;8(2):e000966.
  • Simpson TR, Quezada SA, Allison JP. Regulation of CD4 T cell activation and effector function by inducible costimulator (ICOS). Curr Opin Immunol. 2010 Jun;22(3):326–332. doi: 10.1016/j.coi.2010.01.001
  • Sacco AG, Chen R, Worden FP, et al. Pembrolizumab plus cetuximab in patients with recurrent or metastatic head and neck squamous cell carcinoma: an open-label, multi-arm, non-randomised, multicentre, phase 2 trial. Lancet Oncol. 2021 Jun;22(6):883–892.
  • Forster M, Metcalf R, Sacco J, et al. 922P EACH: A phase II study evaluating the safety and anti-tumour activity of avelumab and cetuximab in recurrent/metastatic squamous cell carcinomas. Ann Oncol. 2020 Sep;31:S665. doi: 10.1016/j.annonc.2020.08.1037 Epub 2020 Sep 22.
  • Gulati S, Crist M, Riaz MK, et al. Durvalumab plus cetuximab in patients with recurrent or metastatic head and neck squamous cell carcinoma: an open-label, nonrandomized, phase II clinical trial. Clin Cancer Res. 2023 May 15;29(10):1906–1915. doi: 10.1158/1078-0432.CCR-22-3886
  • Fayette J, Licitra LFL, Harrington KJ, et al. 854O INTERLINK-1: Phase III study of cetuximab (CTX) ± monalizumab (M) in participants (pts) with recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC) with disease progression on/after platinum chemotherapy (CT) and previously treated with an immune checkpoint inhibitor (ICI). Ann Oncol. 2023;34:S554–S555.
  • Bauman JE, Saba NF, Roe D, et al. Randomized phase II trial of ficlatuzumab with or without cetuximab in pan-refractory, recurrent/metastatic head and neck cancer. J Clin Oncol. 2023;41(22):3851–3862. doi: 10.1200/JCO.22.01994
  • Cohen EE, Fayette J, Daste A, et al. Abstract CT012: Clinical activity of MCLA-158 (petosemtamab), an IgG1 bispecific antibody targeting EGFR and LGR5, in advanced head and neck squamous cell cancer (HNSCC). Cancer Res. 2023;83(8_Supplement):CT012–CT012. doi: 10.1158/1538-7445.AM2023-CT012
  • Adkins D, Ley J, Palka K, et al. 358 Ramucirumab in combination with pembrolizumab as first-line treatment for recurrent or metastatic head and neck squamous-cell carcinoma: a phase 1–2 trial. J Immunother Cancer. 2021;9(Suppl 2):A385–A385. doi: 10.1136/jitc-2021-SITC2021.358
  • Cho BC, Abreu DR, Hussein M, et al. Tiragolumab plus atezolizumab versus placebo plus atezolizumab as a first-line treatment for PD-L1-selected non-small-cell lung cancer (CITYSCAPE): primary and follow-up analyses of a randomised, double-blind, phase 2 study. Lancet Oncol. 2022 Jun;23(6):781–792.
  • Roche provides update on phase III Skyscraper-01 study in PD-L1-high metastatic non-small cell lung cancer. [Internet]. News release; 2023 Aug 23 [cited 2023 Nov 8]. Available from: roche.com/media/releases/med-cor-2023-08-23
  • Hamid O, Gutierrez M, Mehmi I, et al. A phase 1/2 study of retifanlimab (INCMGA00012, Anti–PD-1), INCAGN02385 (Anti–LAG-3), and INCAGN02390 (Anti–TIM-3) combination therapy in patients (Pts) with advanced solid tumors. J Clin Oncol. 2023;41(16_suppl):2599–2599. doi: 10.1200/JCO.2023.41.16_suppl.2599
  • Hansen A, Bauer TM, Moreno V, et al. 1138PD - First in human study with GSK3359609 [GSK609], inducible T cell co-stimulator (ICOS) receptor agonist in patients [Pts] with advanced, solid tumors: Preliminary results from INDUCE-1. Ann Oncol. 2018;29:viii 404. doi: 10.1093/annonc/mdy288.011
  • Massarelli E, Balmanoukian AS, Vieito M, et al. INDUCE-1: Report on safety run-in cohorts combining Inducible T-cell co-stimulatory receptor (ICOS) agonist GSK3359609 (GSK609) with platinum+5-FU chemotherapy (5-FU/plat), with or without pembrolizumab (PE), for the treatment of advanced solid tumors. J Clin Oncol. 2020;38(15_suppl):6544–6544. doi: 10.1200/JCO.2020.38.15_suppl.6544
  • Rischin D, Groenland SL, Lim AML, et al. 1119PD - Inducible T cell costimulatory (ICOS) receptor agonist, GSK3359609 (GSK609) alone and in combination with pembrolizumab (pembro): Preliminary results from INDUCE-1 expansion cohorts (EC) in head and neck squamous cell carcinoma (HNSCC). Annals Of Oncology. 2019;30:v454–v455. doi: 10.1093/annonc/mdz252.011
  • GSK provides update on feladilimab, an investigational inducible T cell co-stimulatory (ICOS) agonist. [Internet]. NewsRelease; Apr 14, 2021 [cited Nov 8, 2023]. Available from: https://www.gsk.com/en-gb/media/press-releases/gsk-provides-update-on-feladilimab-an-investigational-inducible-t-cell-co-stimulatory-icos-agonist/2021
  • Avice MN, Sarfati M, Triebel F, et al. Lymphocyte activation gene-3, a MHC class II ligand expressed on activated T cells, stimulates TNF-alpha and IL-12 production by monocytes and dendritic cells. J Immunol. 1999 Mar 1;162(5):2748–2753. doi: 10.4049/jimmunol.162.5.2748
  • Legat A, Maby-El Hajjami H, Baumgaertner P, et al. Vaccination with LAG-3Ig (IMP321) and Peptides Induces Specific CD4 and CD8 T-Cell responses in metastatic melanoma patients–report of a phase I/IIa Clinical Trial. Clin Cancer Res. 2016 Mar 15;22(6):1330–1340. doi: 10.1158/1078-0432.CCR-15-1212
  • Felip E, Majem M, Doger B, et al. A phase II study (TACTI-002) in first-line metastatic non–small cell lung carcinoma investigating eftilagimod alpha (soluble LAG-3 protein) and pembrolizumab: Updated results from a PD-L1 unselected population. J Clin Oncol. 2022;40(16_suppl):9003–9003. doi: 10.1200/JCO.2022.40.16_suppl.9003
  • Immutep’s efti in combination with pembrolizumab achieves excellent initial overall survival benefit in 1st line non-small cell lung cancer [Internet]. Press releases.; 2023 May 1. [cited 2023 Nov 8]. Available from: https://www.immutep.com/detail/immutep-s-efti-in-combination-with-pembrolizumab-achieves-excellent-initial-overall-survival-benefit-in-1st-line-non-small-cell-lung-cancer.html
  • BDd S, Felip E, Forster M, et al. Final results from TACTI-002 Part C: A phase II study of eftilagimod alpha (soluble LAG-3 protein) and pembrolizumab in patients with metastatic 2nd line head and neck squamous cell carcinoma unselected for PD-L1. J Clin Oncol. 2023;41(16_suppl):6029–6029. doi: 10.1200/JCO.2023.41.16_suppl.6029
  • Stepan LP, Trueblood ES, Hale K, et al. Expression of Trop2 cell surface glycoprotein in normal and tumor tissues: potential implications as a cancer therapeutic target. J Histochem Cytochem. 2011 Jul;59(7):701–710.
  • Lombardi P, Filetti M, Falcone R, et al. Overview of Trop-2 in cancer: from pre-clinical studies to future directions in clinical settings. Cancers (Basel). 2023 Mar 13;15(6):1744. doi: 10.3390/cancers15061744
  • Guerra E, Trerotola M, Tripaldi R, et al. Trop-2 Induces tumor growth through AKT and determines sensitivity to AKT Inhibitors. Clin Cancer Res. 2016 Aug 15;22(16):4197–4205. doi: 10.1158/1078-0432.CCR-15-1701
  • Zeng P, Chen MB, Zhou LN, et al. Impact of TROP2 expression on prognosis in solid tumors: a systematic review and meta-analysis. Sci Rep. 2016 Sep 20;6(1):33658. doi: 10.1038/srep33658
  • Fong D, Spizzo G, Gostner JM, et al. TROP2: a novel prognostic marker in squamous cell carcinoma of the oral cavity. Mod Pathol. 2008 Feb;21(2):186–191.
  • Wu H, Xu H, Zhang S, et al. Potential therapeutic target and independent prognostic marker of TROP2 in laryngeal squamous cell carcinoma. Head Neck. 2013 Oct;35(10):1373–1378.
  • Bardia A, Hurvitz SA, Tolaney SM, et al. Sacituzumab govitecan in metastatic triple-negative breast cancer. N Engl J Med. 2021 Apr 22;384(16):1529–1541. doi: 10.1056/NEJMoa2028485
  • Michel L, Jimeno A, Sukari A, et al. 859MO Sacituzumab govitecan (SG) in patients (pts) with relapsed/refractory (R/R) advanced head and neck squamous cell carcinoma (HNSCC): Results from the phase II TROPiCS-03 basket trial. Ann Oncol. 2023;34:S558. doi: 10.1016/j.annonc.2023.09.2005
  • Qiu M-Z, Zhang Y, Guo Y, et al. Evaluation of safety of treatment with anti–epidermal growth factor receptor antibody drug conjugate MRG003 in patients with advanced solid tumors: a phase 1 nonrandomized clinical trial. JAMA Oncol. 2022;8(7):1042–1046. doi: 10.1001/jamaoncol.2022.0503
  • de Bono JS, Harris JR, Burm SM, et al. Systematic study of tissue factor expression in solid tumors. Cancer Rep (Hoboken). 2023 Feb;6(2):e1699.
  • Gray E, Hensley K, Allred S, et al. 617 Tisotumab vedotin shows immunomodulatory activity through induction of immunogenic cell death. J Immunother Cancer. 2020;8(Suppl 3):A371–A372.
  • Hernandez I, Bott SW, Patel AS, et al. Pricing of monoclonal antibody therapies: higher if used for cancer? Am J Manag Care. 2018 Feb;24(2):109–112.
  • Borse RH, Ramakrishnan K, Gandhi J, et al. Cost-effectiveness of pembrolizumab for the first-line treatment of recurrent or metastatic head and neck squamous cell carcinoma in the United States. J Med Econ. 2022 Jan;25(1):954–965.
  • Derbyshire M. Patent expiry dates for biologicals: 2016 update. GaBI J. 2017;6(1):27–30. doi: 10.5639/gabij.2017.0601.006
  • Douez E, D’Atri V, Guillarme D, et al. Why is there no biosimilar of Erbitux®? J Pharm Biomed Anal. 2023 Sep 20;234:115544. doi: 10.1016/j.jpba.2023.115544
  • Hannouf MB, Sehgal C, Cao JQ, et al. Cost-effectiveness of adding cetuximab to platinum-based chemotherapy for first-line treatment of recurrent or metastatic head and neck cancer. PLOS One. 2012;7(6):e38557. doi: 10.1371/journal.pone.0038557
  • Johnson DB, Nebhan CA, Moslehi JJ, et al. Immune-checkpoint inhibitors: long-term implications of toxicity. Nat Rev Clin Oncol. 2022 Apr;19(4):254–267. doi: 10.1038/s41571-022-00600-w
  • Gotsman I, Grabie N, Dacosta R, et al. Proatherogenic immune responses are regulated by the PD-1/PD-L pathway in mice. J Clin Invest. 2007 Oct;117(10):2974–2982.
  • Ozkaynak E, Gao W, Shemmeri N, et al. Importance of ICOS-B7RP-1 costimulation in acute and chronic allograft rejection. Nat Immunol. 2001 Jul;2(7):591–596.
  • Drobni ZD, Alvi RM, Taron J, et al. Association between immune checkpoint inhibitors with cardiovascular events and atherosclerotic plaque. Circulation. 2020 Dec 15;142(24):2299–2311. doi: 10.1161/CIRCULATIONAHA.120.049981
  • Powles T, Valderrama BP, Gupta S, et al. Enfortumab vedotin and pembrolizumab in untreated advanced urothelial cancer. N Engl J Med. 2024 Mar 7;390(10):875–888. doi: 10.1056/NEJMoa2312117
  • Price KAR, Kaczmar JM, Worden FP, et al. Safety and efficacy of immune checkpoint inhibitor (ICI) naïve cohort from study of PDS0101 and pembrolizumab in HPV16-positive head and neck squamous cell carcinoma (HNSCC). J Clin Oncol. 2023;41(16_suppl):6012–6012. doi: 10.1200/JCO.2023.41.16_suppl.6012
  • Sousa LG, Rajapakshe K, Rodriguez Canales J, et al. ISA101 and nivolumab for HPV-16 + cancer: updated clinical efficacy and immune correlates of response. J Immunother Cancer. 2022 Feb;10(2):e004232.
  • Zhang S, Zheng M, Nie D, et al. Efficacy of cetuximab plus PD-1 inhibitor differs by HPV status in head and neck squamous cell carcinoma: a systematic review and meta-analysis. J Immunother Cancer. 2022 Oct;10(10):e005158.

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