A cancer research UK first time in human phase i trial of IMA950 (novel multipeptide therapeutic vaccine) in patients with newly diagnosed glioblastoma

Clinical Cancer Research

Volumn 22, Issue 19, 2016, Pages 4776-4785

  Rampling, Roy ^a   Peoples, Sharon ^b   Mulholland, Paul J ^c   James, Allan ^a   Al Salihi, Omar ^d   Twelves, Christopher J ^e   McBain, Catherine ^f   Jefferies, Sarah ^g   Jackson, Alan ^h   Stewart, Willie ⁱ   Lindner, Juha ^j   Kutscher, Sarah ^j   Hilf, Norbert ^j   McGuigan, Lesley ^k   Peters, Jane ^k   Hill, Karen ^k   Schoor, Oliver ^j   Singh Jasuja, Harpreet ^j   Halford, Sarah E ^k   Ritchie, James W A ^k  

^a UNIVERSITY OF GLASGOW   (United Kingdom)

^b WESTERN GENERAL HOSPITAL   (United Kingdom)

^c UNIVERSITY COLLEGE LONDON HOSPITALS   (United Kingdom)

^d UNIVERSITY HOSPITAL SOUTHAMPTON NHS FOUNDATION TRUST   (United Kingdom)

^e ST JAMES S UNIVERSITY HOSPITAL   (United Kingdom)

^f CHRISTIE HOSPITAL   (United Kingdom)

^g ADDENBROOKE S HOSPITAL   (United Kingdom)

^h UNIVERSITY OF MANCHESTER   (United Kingdom)

ⁱ QUEEN ELIZABETH UNIVERSITY HOSPITAL   (United Kingdom)

^j IMMATICS BIOTECHNOLOGIES GMBH   (Germany)

^k IMPERIAL CANCER RESEARCH FUND   (United Kingdom)

more..

Author keywords

[No Author keywords available]

Indexed keywords

CANCER VACCINE; GRANULOCYTE MACROPHAGE COLONY STIMULATING FACTOR; HLA ANTIGEN CLASS 2; IMA 950; STEROID; TEMOZOLOMIDE; UNCLASSIFIED DRUG; ANTINEOPLASTIC AGENT; IMA950; PEPTIDE; TUMOR ANTIGEN;

ADULT; AGED; ANAPHYLAXIS; ANEMIA; CANCER ADJUVANT THERAPY; CANCER IMMUNIZATION; CANCER PROGNOSIS; CANCER SURGERY; CELLULAR IMMUNITY; CHEMORADIOTHERAPY; COHORT ANALYSIS; CONFERENCE PAPER; DRUG EFFECT; DRUG HYPERSENSITIVITY; DRUG SAFETY; DRUG TOLERANCE; FATIGUE; FEMALE; GLIOBLASTOMA; HUMAN; IMMUNOGENICITY; INJECTION SITE REACTION; MAJOR CLINICAL STUDY; MALE; MULTIPLE CYCLE TREATMENT; NEUTROPENIA; PHASE 1 CLINICAL TRIAL (TOPIC); PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; PRURITUS; RASH; REGULATORY T LYMPHOCYTE; TREATMENT DURATION; TREATMENT RESPONSE; BRAIN TUMOR; CLINICAL TRIAL; DISEASE FREE SURVIVAL; DRUG EFFECTS; IMMUNOLOGY; KAPLAN MEIER METHOD; LYMPHOCYTE ACTIVATION; MIDDLE AGED; MORTALITY; PHASE 1 CLINICAL TRIAL; PROCEDURES; T LYMPHOCYTE; UNITED KINGDOM; YOUNG ADULT;

ADULT; AGED; ANTIGENS, NEOPLASM; ANTINEOPLASTIC AGENTS; BRAIN NEOPLASMS; CANCER VACCINES; CHEMORADIOTHERAPY; DISEASE-FREE SURVIVAL; FEMALE; GLIOBLASTOMA; HUMANS; KAPLAN-MEIER ESTIMATE; LYMPHOCYTE ACTIVATION; MALE; MIDDLE AGED; PEPTIDES; T-LYMPHOCYTES; UNITED KINGDOM; YOUNG ADULT;

EID: 84991260353     PISSN: 10780432     EISSN: 15573265     Source Type: Journal    
DOI: 10.1158/1078-0432.CCR-16-0506     Document Type: Conference Paper

References (49)

1. Schwartzbaum JA, Fisher JL, Aldape KD, Wrensch M. Epidemiology and molecular pathology of glioma. Nat Clin Pract Neurol 2006;2:494-503.
2. Stupp R, Mason WP, van den Bent MJ, Weller M, Fisher B, Taphoorn MJ, et al. Radiotherapy plus concomitant and adjuvant temozolomide for glioblastoma. N Engl J Med 2005;352:987-96.
3. Dolecek TA, Propp JM, Stroup NE, Kruchko C. CBTRUS statistical report: primary brain and central nervous system tumors diagnosed in the United States in 2005-2009. Neuro-oncology 2012;14Suppl 5:v1-49.
4. Dobes M, Khurana VG, Shadbolt B, Jain S, Smith SF, Smee R, et al. Increasing incidence of glioblastoma multiforme and meningioma, and decreasing incidence of Schwannoma (2000-2008): findings of a multicenter Australian study. Surg Neurol Int 2011;2:176.
5. Johnson DR. Rising incidence of glioblastoma and meningioma in the United States: projections through 2050. J Clin Oncol 30, 2012(suppl; abstr 2065).
6. Dutoit V, Herold-Mende C, Hilf N, Schoor O, Beckhove P, Bucher J, et al. Exploiting the glioblastoma peptidome to discover novel tumour-associated antigens for immunotherapy. Brain 2012;135:1042-54.
7. WidenmeyerM,GriesemannH, Stevanovic S, Feyerabend S,Klein R, Attig S, et al. Promiscuous survivin peptide induces robust CD4+ T-cell responses in themajority of vaccinated cancer patients. Int J Cancer 2012;131:140-9.
8. Li Y, Li A, Glas M, Lal B, Ying M, Sang Y, et al. c-Met signaling induces a reprogramming network and supports the glioblastoma stem-like phenotype. Proc Natl Acad Sci U S A 2011;108:9951-6.
9. Melief CJ, van der Burg SH. Immunotherapy of established (pre)malignant disease by synthetic long peptide vaccines.Nat Rev Cancer 2008;8:351-60.
10. Parmiani G, Castelli C, Pilla L, Santinami M, Colombo MP, Rivoltini L. Opposite immune functions of GM-CSF administered as vaccine adjuvant in cancer patients. Ann Oncol 2007;18:226-32.
11. Macdonald DR, Cascino TL, Schold SCJr, Cairncross JG. Response criteria for phase II studies of supratentorial malignant glioma. J Clin Oncol 1990;8:1277-80.
12. Chudley L, McCann KJ, Coleman A, Cazaly AM, Bidmon N, Britten CM, et al. Harmonisation of short-term in vitro culture for the expansion of antigen-specific CD8(+) T cells with detection by ELISPOT and HLAmultimer staining. Cancer Immunol Immunother 2014;63:1199-211.
13. Walter S, Weinschenk T, Stenzl A, Zdrojowy R, PluzanskaA, Szczylik C, et al. Multipeptide immune response to cancer vaccine IMA901 after single-dose cyclophosphamide associates with longer patient survival. Nat Med 2012;18:1254-61.
14. Britten CM, Janetzki S, Ben-Porat L, Clay TM, Kalos M, Maecker H, et al. Harmonization guidelines for HLA-peptide multimer assays derived from results of a large scale international proficiency panel of the Cancer Vaccine Consortium. Cancer Immunol Immunother 2009;58:1701-13.
15. Seddiki N, Santner-Nanan B, Martinson J, Zaunders J, Sasson S, Landay A, et al. Expression of interleukin (IL)-2 and IL-7 receptors discriminates between human regulatory and activated T cells. J Exp Med 2006;203: 1693-700.
16. Okada H, Weller M, Huang R, Finocchiaro G, Gilbert MR, Wick W, et al. Immunotherapy response assessment in neuro-oncology: a report of the RANO working group. Lancet Oncol 2015;16:e534-42.
17. Winney B, Boumertit A, Day T,DavisonD, Echeta C, Evseeva I, et al. People of the British Isles: preliminary analysis of genotypes and surnames in a UKcontrol population. Eur J Hum Genet 2012;20:203-10.
18. Kempuraj D, Devi RS, Madhappan B, Conti P, Nazer MY, Christodoulou S, et al. T lymphocyte subsets and immunoglobulins in intracranial tumor patients before and after treatment, and based on histological type of tumors. Int J Immunopathol Pharmacol 2004;17:57-64.
19. Kocher M, Kunze S, Eich HT, Semrau R, Muller RP. Efficacy and toxicity of postoperative temozolomide radiochemotherapy in malignant glioma. Strahlenther Onkol 2005;181:157-63.
20. Campbell DJ, Koch MA. Phenotypical and functional specialization of FOXP3+ regulatory T cells. Nat Rev Immunol 2011;11:119-30.
21. Butt AQ, Mills KH. Immunosuppressive networks and checkpoints controlling antitumor immunity and their blockade in the development of cancer immunotherapeutics and vaccines. Oncogene 2014;33:4623-31.
22. Chiba Y, Hashimoto N, Tsuboi A, Oka Y, Murao A, Kinoshita M, et al. Effects of concomitant temozolomide and radiation therapies on WT1-specific T-cells in malignant glioma. Jpn J Clin Oncol 2010;40: 395-403.
23. Sampson JH, Aldape KD, Archer GE, Coan A, Desjardins A, Friedman AH, et al. Greater chemotherapy-induced lymphopenia enhances tumor-specific immune responses that eliminate EGFRvIII-expressing tumor cells in patients with glioblastoma. Neuro-oncology 2011; 13:324-33.
24. Fadul CE, Fisher JL, Gui J, Hampton TH, Cote AL, Ernstoff MS. Immune modulation effects of concomitant temozolomide and radiation therapy on peripheral blood mononuclear cells in patients with glioblastoma multiforme. Neuro-oncology 2011;13:393-400.
25. Ghiringhelli F, Menard C, Puig PE, Ladoire S, Roux S, Martin F, et al. Metronomic cyclophosphamide regimen selectively depletes CD4+CD25+ regulatory T cells and restores T and NK effector functions in end stage cancer patients. Cancer Immunol Immunother 2007;56:641-8.
26. Lutsiak ME, Semnani RT, De Pascalis R, Kashmiri SV, Schlom J, Sabzevari H. Inhibition of CD4(+)25+ T regulatory cell function implicated in enhanced immune response by low-dose cyclophosphamide. Blood 2005;105:2862-8.
27. Inamoto T, Azuma H. Immunotherapy of genitourinary malignancies. J Oncol 2012;2012:397267.
28. Nduom EK, Weller M, Heimberger AB. Immunosuppressive mechanisms in glioblastoma. Neuro-oncology 2015;17Suppl 7:vii9-vii14.
29. Authier A, Farrand KJ, Broadley KW, Ancelet LR, Hunn MK, Stone S, et al. Enhanced immunosuppression by therapy-exposed glioblastoma multiforme tumor cells. Int J Cancer 2015;136:2566-78.
30. Wainwright DA, Dey M, Chang A, Lesniak MS. Targeting tregs in malignant brain cancer: overcoming IDO. Front Immunol 2013;4:116.
31. Berghoff AS, Kiesel B, Widhalm G, Rajky O, Ricken G, Wohrer A, et al. Programmed death ligand 1 expression and tumor-infiltrating lymphocytes in glioblastoma. Neuro-oncology 2015;17:1064-75.
32. Wainwright DA, Chang AL, Dey M, Balyasnikova IV, KimCK, Tobias A, et al. Durable therapeutic efficacy utilizing combinatorial blockade against IDO, CTLA-4, and PD-L1 in mice with brain tumors. Clin Cancer Res 2014; 20:5290-301.
33. Dranoff G, Jaffee E, Lazenby A, Golumbek P, Levitsky H, Brose K, et al. Vaccination with irradiated tumor cells engineered to secrete murine granulocyte-macrophage colony-stimulating factor stimulates potent, specific, and long-lasting anti-tumor immunity. Proc Natl Acad Sci U S A 1993;90:3539-43.
34. Ahlers JD, Dunlop N, Alling DW, Nara PL, Berzofsky JA. Cytokine-inadjuvant steering of the immune response phenotype to HIV-1 vaccine constructs: granulocyte-macrophage colony-stimulating factor and TNFalpha synergize with IL-12 to enhance induction of cytotoxic T lymphocytes. J Immunol 1997;158:3947-58.
35. Hege KM, Jooss K, Pardoll D. GM-CSF gene-modifed cancer cell immunotherapies: of mice and men. Int Rev Immunol 2006;25:321-52.
36. Kaufman HL, Ruby CE, Hughes T, Slingluff CLJr. Current status of granulocyte- macrophage colony-stimulating factor in the immunotherapy of melanoma. J Immunother Cancer 2014;2:11.
37. Martins KA, Bavari S, Salazar AM. Vaccine adjuvant uses of poly-IC and derivatives. Expert Rev Vaccines 2015;14:447-59.
38. Fehres CM, Bruijns SC, van Beelen AJ, Kalay H, Ambrosini M, Hooijberg E, et al. Topical rather than intradermal application of the TLR7 ligand imiquimod leads to human dermal dendritic cell maturation and CD8+ T-cell cross-priming. Eur J Immunol 2014;44:2415-24.
39. Gupta S, Termini JM, Kanagavelu S, Stone GW. Design of vaccine adjuvants incorporating TNF superfamily ligands and TNF superfamily molecular mimics. Immunol Res 2013;57:303-10.
40. Madondo MT, Quinn M, Plebanski M. Low dose cyclophosphamide: mechanisms of T cellmodulation. Cancer Treat Rev 2016;42:3-9.
41. Fu J, Malm IJ, Kadayakkara DK, Levitsky H, Pardoll D, Kim YJ. Preclinical evidence that PD1 blockade cooperates with cancer vaccine TEGVAX to elicit regression of established tumors. Cancer Res 2014;74:4042-52.
42. Le DT, Lutz E, Uram JN, Sugar EA, Onners B, Solt S, et al. Evaluation of ipilimumab in combination with allogeneic pancreatic tumor cells transfected with a GM-CSF gene in previously treated pancreatic cancer. J Immunother 2013;36:382-9.
43. Aruga A, TakeshitaN, Kotera Y,Okuyama R, MatsushitaN, Ohta T, et al. Long-term vaccination with multiple peptides derived from cancertestis antigens can maintain a specific T-cell response and achieve disease stability in advanced biliary tract cancer. Clin Cancer Res 2013;19:2224-31.
44. Fukushima T, Takeshima H, Kataoka H. Anti-glioma therapy with temozolomide and status of the DNA-repair gene MGMT. Anticancer Res 2009;29:4845-54.
45. Hoos A. Evolution of end points for cancer immunotherapy trials. Ann Oncol 2012;23Suppl 8:viii47-52.
46. Del Vecchio CA, Wong AJ. Rindopepimut, a 14-mer injectable peptide vaccine against EGFRvIII for the potential treatment of glioblastoma multiforme. Curr Opin Mol Ther 2010;12:741-54.
47. Schuster J, Lai RK, Recht LD, Reardon DA, Paleologos NA, Groves MD, et al. A phase II, multicenter trial of rindopepimut (CDX-110) in newly diagnosed glioblastoma: the ACT III study. Neuro-oncology 2015;17: 854-61.
48. Celldex Therapeutics. Data Safety and Monitoring Board recommends Celldex's phase 3 study of RINTEGA (rindopepimut) in newly diagnosed glioblastoma be discontinued as it is unlikely to meet primary overall survival endpoint in patients with minimal residual disease 2016. [cited 2016 01 April]; Available from: http://ir.celldex.com/releasedetail.cfm? ReleaseID=959021.
49. Grossman SA, Ye X, Piantadosi S,Desideri S, Nabors LB, Rosenfeld M, et al. Survival of patients with newly diagnosed glioblastoma treated with radiation and temozolomide in research studies in the United States. Clin Cancer Res 2010;16:2443-9.