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Original Research

A Phase 1b Study Evaluating the Safety, Tolerability, and Immunogenicity of CMB305, a Lentiviral-Based Prime-Boost Vaccine Regimen, in Patients with Locally Advanced, Relapsed, or Metastatic Cancer Expressing NY-ESO-1

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Article: 1847846 | Received 28 Jul 2020, Accepted 03 Nov 2020, Published online: 19 Nov 2020

References

  • Guo C, Manjili MH, Subjeck JR, Sarkar D, Fisher PB, Wang XY. Therapeutic cancer vaccines: past, present, and future. Adv Cancer Res. 2013;119:421–12. doi:10.1016/B978-0-12-407190-2.00007-1.
  • Schlom J, Hodge JW, Palena C, Tsang K-Y, Jochems C, Greiner JW, Farsaci B, Madan RA, Heery CR, Gulley JL. Therapeutic cancer vaccines. Adv Cancer Res. 2014;121:67–124. doi:10.1016/B978-0-12-800249-0.00002-0.
  • Butterfield LH. Cancer vaccines. BMJ. 2015;350:h988. doi:10.1136/bmj.h988.
  • Gatti-Mays ME, Redman JM, Collins JM, Bilusic M. Cancer vaccines: enhanced immunogenic modulation through therapeutic combinations. Hum Vaccin Immunother. 2017;13(11):2561–2574. doi:10.1080/21645515.2017.1364322.
  • Solinas C, Aiello M, Migliori E, Willard-Gallo K, Emens LA. Breast cancer vaccines: heeding the lessons of the past to guide a path forward. Cancer Treat Rev. 2020;84:101947. doi:10.1016/j.ctrv.2019.101947.
  • van der Burg SH. Correlates of immune and clinical activity of novel cancer vaccines. Semin Immunol. 2018;39:119–136. doi:10.1016/j.smim.2018.04.001.
  • Endo M, de Graaff MA, Ingram DR, Lim S, Lev DC, Briaire-de Bruijn IH, Somaiah N, Bovée JVMG, Lazar AJ, Nielsen TO. NY-ESO-1 (CTAG1B) expression in mesenchymal tumors. Mod Pathol. 2015;28(4):587–595. doi:10.1038/modpathol.2014.155.
  • Jungbluth AA, Antonescu CR, Busam KJ, Iversen K, Kolb D, Coplan K, Chen YT, Stockert E, Ladanyi M, Old LJ. Monophasic and biphasic synovial sarcomas abundantly express cancer/testis antigen NY-ESO-1 but not MAGE-A1 or CT7. Int J Cancer. 2001;94(2):252–256. doi:10.1002/ijc.1451.
  • Odunsi K, Jungbluth AA, Stockert E, Qian F, Gnjatic S, Tammela J, Intengan M, Beck A, Keitz B, Santiago D,et al. NY-ESO-1 and LAGE-1 cancer-testis antigens are potential targets for immunotherapy in epithelial ovarian cancer. Cancer Res. 2003;63(18):6076–6083.
  • Raza A, Merhi M, Inchakalody VP, Krishnankutty R, Relecom A, Uddin S, Dermime S. Unleashing the immune response to NY-ESO-1 cancer testis antigen as a potential target for cancer immunotherapy. J Transl Med. 2020;18(1):140. doi:10.1186/s12967-020-02306-y.
  • Robbins PF, Morgan RA, Feldman SA, Yang JC, Sherry RM, Dudley ME, Wunderlich JR, Nahvi AV, Helman LJ, Mackall CL, et al. Tumor regression in patients with metastatic synovial cell sarcoma and melanoma using genetically engineered lymphocytes reactive with NY-ESO-1. J Clin Oncol. 2011;29(7):917–924. doi:10.1200/JCO.2010.32.2537.
  • Maraskovsky E, Sjölander S, Drane DP, Schnurr M, Le TTT, Mateo L, Luft T, Masterman K-A, Tai T-Y, Chen Q,et al. NY-ESO-1 protein formulated in ISCOMATRIX adjuvant is a potent anticancer vaccine inducing both humoral and CD8+ t-cell-mediated immunity and protection against NY-ESO-1+ tumors. Clin Cancer Res. 2004;10(8):2879–2890. doi:10.1158/1078-0432.ccr-03-0245.
  • Thomas R, Al-Khadairi G, Roelands J, Hendrickx W, Dermime S, Bedognetti D, Decock J. NY-ESO-1 based immunotherapy of cancer: current perspectives. Front Immunol. 2018;9:947. doi:10.3389/fimmu.2018.00947.
  • Pollack SM, Jungbluth AA, Hoch BL, Farrar EA, Bleakley M, Schneider DJ, Loggers ET, Rodler E, Eary JF, Conrad III EU, et al. NY-ESO-1 is a ubiquitous immunotherapeutic target antigen for patients with myxoid/round cell liposarcoma. Cancer. 2012;118(18):4564–4570. doi:10.1002/cncr.27446.
  • Albershardt TC, Parsons AJ, Reeves RS, Flynn PA, Campbell DJ, Ter Meulen J, Berglund P. Therapeutic efficacy of PD1/PDL1 blockade in B16 melanoma is greatly enhanced by immunization with dendritic cell-targeting lentiviral vector and protein vaccine. Vaccine. 2020;38(17):3369–3377. doi:10.1016/j.vaccine.2020.02.034.
  • Alpizar YA, Karwacz K, Arce F, Rivera AY, Fernández LE, Collins MK, Ramírez BS. Lentiviral vector followed by protein immunisation breaks tolerance against the self-antigen Her1 and results in lung cancer immunotherapy. J Gene Med. 2012;14(3):151–157. doi:10.1002/jgm.2606.
  • Otten GR, Schaefer M, Doe B, Liu H, Srivastava I, zur Megede J, Kazzaz J, Lian Y, Singh M, Ugozzoli M, et al. Enhanced potency of plasmid DNA microparticle human immunodeficiency virus vaccines in rhesus macaques by using a priming-boosting regimen with recombinant proteins. J Virol. 2005;79(13):8189–8200. doi:10.1128/JVI.79.13.8189-8200.2005.
  • Richmond JF, Lu S, Santoro JC, Weng J, Hu S-L, Montefiori DC, Robinson HL. Studies of the neutralizing activity and avidity of anti-human immunodeficiency virus type 1 Env antibody elicited by DNA priming and protein boosting. J Virol. 1998;72(11):9092–9100. doi:10.1128/JVI.72.11.9092-9100.1998.
  • Wang S, Parker C, Taaffe J, Solórzano A, García-Sastre A, Lu S. Heterologous HA DNA vaccine prime–inactivated influenza vaccine boost is more effective than using DNA or inactivated vaccine alone in eliciting antibody responses against H1 or H3 serotype influenza viruses. Vaccine. 2008;26(29–30):3626–3633. doi:10.1016/j.vaccine.2008.04.073.
  • Albershardt TC, Campbell DJ, Parsons AJ, Slough MM, Ter Meulen J, Berglund P. LV305, a dendritic cell-targeting integration-deficient ZVex TM -based lentiviral vector encoding NY-ESO-1, induces potent anti-tumor immune response. Mol Ther Oncolytics. 2016;3:16010. doi:10.1038/mto.2016.10.
  • Odegard JM, Kelley-Clarke B, Tareen SU, Campbell DJ, Flynn PA, Nicolai CJ, Slough MM, Vin CD, McGowan PJ, Nelson LT, et al. Virological and preclinical characterization of a dendritic cell targeting, integration-deficient lentiviral vector for cancer immunotherapy. J Immunother. 2015;38(2):41–53. doi:10.1097/CJI.0000000000000067.
  • Tareen SU, Kelley-Clarke B, Nicolai CJ, Cassiano LA, Nelson LT, Slough MM, Vin CD, Odegard JM, Sloan DD, Van Hoeven N, et al. Design of a novel integration-deficient lentivector technology that incorporates genetic and posttranslational elements to target human dendritic cells. Mol Ther. 2014;22(3):575–587. doi:10.1038/mt.2013.278.
  • Somaiah N, Block MS, Kim JW, Shapiro GI, Do KT, Hwu P, Eder JP, Jones RL, Lu H, Ter Meulen JH, et al. First-in-class, first-in-human study evaluating LV305, a dendritic-cell tropic lentiviral vector, in sarcoma and other solid tumors expressing NY-ESO-1. Clin Cancer Res. 2019;25(19):5808–5817. doi:10.1158/1078-0432.CCR-19-1025.
  • Pollack SM, Lu H, Gnjatic S, Somaiah N, O’Malley RB, Jones RL, Hsu FJ, Ter Meulen J. First-in-human treatment with a dendritic cell-targeting lentiviral vector-expressing NY-ESO-1, LV305, induces deep, durable response in refractory metastatic synovial sarcoma patient. J Immunother. 2017;40(8):302–306. doi:10.1097/CJI.0000000000000183.
  • Mahipal A, Ejadi S, Gnjatic S, Kim-Schulze S, Lu H, Ter Meulen JH, Kenney R, Odunsi K. First-in-human phase 1 dose-escalating trial of G305 in patients with advanced solid tumors expressing NY-ESO-1. Cancer Immunol Immunother. 2019;68(7):1211–1222. doi:10.1007/s00262-019-02331-x.
  • Le DT, Jaffee EM. Regulatory T-cell modulation using cyclophosphamide in vaccine approaches: a current perspective. Cancer Res. 2012;72(14):3439–3444. doi:10.1158/0008-5472.CAN-11-3912.
  • Hermans IF, Chong TW, Palmowski MJ, Harris AL, Cerundolo V. Synergistic effect of metronomic dosing of cyclophosphamide combined with specific antitumor immunotherapy in a murine melanoma model. Cancer Res. 2003;63(23):8408–8413.
  • Albershardt TC, Leleux J, Parsons AJ, Krull JE, Berglund P, Ter Meulen J. Intratumoral immune activation with TLR4 agonist synergizes with effector T-cells to eradicate established murine tumors. NPJ Vaccines. 2020;5:50. doi:10.1038/s41541-020-0201-x.
  • National Cancer Institute. Common terminology criteria for adverse events (CTCAE), version 4.03. Bethesda (MD): U.S. Department of Health and Human Services - National Institutes of Health; 2010.
  • Nishino M, Giobbie-Hurder A, Gargano M, Suda M, Ramaiya NH, Hodi FS. Developing a common language for tumor response to immunotherapy: immune-related response criteria using unidimensional measurements. Clin Cancer Res. 2013;19(14):3936–3943. doi:10.1158/1078-0432.CCR-13-0895.
  • Wolchok JD, Hoos A, O’Day S, Weber JS, Hamid O, Lebb éC, Maio M, Binder M, Bohnsack O, Nichol G, et al. Guidelines for the evaluation of immune therapy activity in solid tumors: immune-related response criteria. Clin Cancer Res. 2009;15(23):7412–7420. doi:10.1158/1078-0432.CCR-09-1624.
  • Norton TD, Miller EA. Recent advances in lentiviral vaccines for HIV-1 infection. Front Immunol. 2016;7:243. doi:10.3389/fimmu.2016.00243.
  • Hu B, Tai A, Wang P. Immunization delivered by lentiviral vectors for cancer and infectious diseases. Immunol Rev. 2011;239(1):45–61. doi:10.1111/j.1600-065X.2010.00967.x.
  • Yuan J, Adamow M, Ginsberg BA, Rasalan TS, Ritter E, Gallardo HF, Xu Y, Pogoriler E, Terzulli SL, Kuk D, et al. Integrated NY-ESO-1 antibody and CD8+ T-cell responses correlate with clinical benefit in advanced melanoma patients treated with ipilimumab. Proc Natl Acad Sci U S A. 2011;108(40):16723–16728. doi:10.1073/pnas.1110814108.
  • Melief CJM, van Hall T, Arens R, Ossendorp F, van der Burg SH. Therapeutic cancer vaccines. J Clin Invest. 2015;125(9):3401–3412. doi:10.1172/JCI80009.
  • Dhodapkar MV, Sznol M, Zhao B, Wang D, Carvajal RD, Keohan ML, Chuang E, Sanborn RE, Lutzky J, Powderly J, et al. Induction of antigen-specific immunity with a vaccine targeting NY-ESO-1 to the dendritic cell receptor DEC-205. Sci Transl Med. 2014;6(232):232ra51. doi:10.1126/scitranslmed.3008068.
  • Kawaguchi S, Tsukahara T, Ida K, Kimura S, Murase M, Kano M, Emori M, Nagoya S, Kaya M, Torigoe T, et al. SYT-SSX breakpoint peptide vaccines in patients with synovial sarcoma: a study from the Japanese musculoskeletal oncology group. Cancer Sci. 2012;103(9):1625–1630. doi:10.1111/j.1349-7006.2012.02370.x.
  • Carvajal RD, Agulnik M, Ryan CW, Milhem MM, George S, Jones RL, Chmielowski B, Van Tine BA, Tawbi HAH, Elias AD, et al. Trivalent ganglioside vaccine and immunologic adjuvant versus adjuvant alone in metastatic sarcoma patients rendered disease-free by surgery: A randomized phase 2 trial [abstract]. J Clin Oncol. 2014;32(15_Suppl):10520. doi:10.1200/jco.2014.32.15_suppl.10520.
  • Rosenberg SA, Yang JC, Restifo NP. Cancer immunotherapy: moving beyond current vaccines. Nat Med. 2004;10(9):909–915. doi:10.1038/nm1100.
  • Savina M, Le Cesne A, Blay J-Y, Ray-Coquard I, Mir O, Toulmonde M, Cousin S, Terrier P, Ranchere-Vince D, Meeus P, et al. Patterns of care and outcomes of patients with METAstatic soft tissue SARComa in a real-life setting: the METASARC observational study. BMC Med. 2017;15(1):78. doi:10.1186/s12916-017-0831-7.
  • van der Graaf WTA, Blay J-Y, Chawla SP, Kim D-W, Bui-Nguyen B, Casali PG, Schöffski P, Aglietta M, Staddon AP, Beppu Y, et al. Pazopanib for metastatic soft-tissue sarcoma (PALETTE): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet. 2012;379(9829):1879–1886. doi:10.1016/S0140-6736(12)60651-5.
  • Schöffski P, Chawla S, Maki RG, Italiano A, Gelderblom H, Choy E, Grignani G, Camargo V, Bauer S, Rha SY, et al. Eribulin versus dacarbazine in previously treated patients with advanced liposarcoma or leiomyosarcoma: a randomised, open-label, multicentre, phase 3 trial. Lancet. 2016;387(10028):1629–1637. doi:10.1016/S0140-6736(15)01283-0.
  • Demetri GD, von Mehren M, Jones RL, Hensley ML, Schuetze SM, Staddon A, Milhem M, Elias A, Ganjoo K, Tawbi H, et al. Efficacy and safety of trabectedin or dacarbazine for metastatic liposarcoma or leiomyosarcoma after failure of conventional chemotherapy: results of a phase III randomized multicenter clinical trial. J Clin Oncol. 2016;34(8):786–793. doi:10.1200/JCO.2015.62.4734.
  • Pollack SM. The potential of the CMB305 vaccine regimen to target NY-ESO-1 and improve outcomes for synovial sarcoma and myxoid/round cell liposarcoma patients. Expert Rev Vaccines. 2018;17(2):107–114. doi:10.1080/14760584.2018.1419068.
  • Pender A, Jones RL, Pollack S. Optimising cancer vaccine design in sarcoma. Cancers (Basel). 2018;11(1):1. doi:10.3390/cancers11010001.
  • Zhang S, Kohli K, Black RG, Yao L, Spadinger SM, He Q, Pillarisetty VG, Cranmer LD, Van Tine BA, Yee C, et al. Systemic interferon-gamma increases MHC Class I expression and T-cell infiltration in cold tumors: results of a phase 0 clinical trial. Cancer Immunol Res. 2019;7(8):1237–1243. doi:10.1158/2326-6066.CIR-18-0940.
  • D’Angelo SP, Tap WD, Schwartz GK, Carvajal RD. Sarcoma immunotherapy: past approaches and future directions. Sarcoma. 2014;2014:391967. doi:10.1155/2014/391967.
  • Tap WD, Wagner AJ, Schöffski P, Martin-Broto J, Krarup-Hansen A, Ganjoo KN, Yen C-C, Abdul Razak AR, Spira A, Kawai A, et al. Effect of doxorubicin plus olaratumab vs doxorubicin plus placebo on survival in patients with advanced soft tissue sarcomas: the ANNOUNCE randomized clinical trial. JAMA. 2020;323(13):1266–1276. doi:10.1001/jama.2020.1707.
  • Riedel RF, Jones RL, Italiano A, Bohac C, Thompson JC, Mueller K, Khan Z, Pollack SM, Van Tine BA. Systemic anti-cancer therapy in synovial sarcoma: a systematic review. Cancers (Basel). 2018;10(11):417. doi:10.3390/cancers10110417.
  • Pollack SM, Ingham M, Spraker MB, Schwartz GK. Emerging targeted and immune-based therapies in sarcoma. J Clin Oncol. 2018;36(2):125–135. doi:10.1200/JCO.2017.75.1610.