The immuno-oncology framework enabling a new era of cancer therapy a new era of cancer therapy

OncoImmunology

Volumn 1, Issue 3, 2012, Pages 334-339

  Hoos, Axel ^a   Britten, Cedrik M ^b,c  

^a Cancer Immunotherapy Consortium (CIC)   (United States)

^b Association for Cancer Immunotherapy   (Germany)

^c Ribological GmbH   (Germany)

Author keywords

[No Author keywords available]

Indexed keywords

CANCER VACCINE; CYTOTOXIC T LYMPHOCYTE ANTIGEN 4 ANTIBODY; IPILIMUMAB; TICILIMUMAB;

ADVANCED CANCER; ANALYTIC METHOD; ANTINEOPLASTIC ACTIVITY; ARTICLE; CANCER IMMUNOLOGY; CANCER IMMUNOTHERAPY; CANCER RESEARCH; CANCER SURVIVAL; CELLULAR IMMUNITY; CLINICAL DEVELOPMENT PLAN; CONCEPTUAL FRAMEWORK; DRUG INDUSTRY; HUMAN; IMMUNOASSAY; IMMUNOLOGICAL MONITORING; INTERDISCIPLINARY COMMUNICATION; MELANOMA; OVERALL SURVIVAL; PRACTICE GUIDELINE; PRIORITY JOURNAL; PROFESSIONAL KNOWLEDGE; PROGRAM DEVELOPMENT; REPRODUCIBILITY; TREATMENT PLANNING; TREATMENT RESPONSE;

EID: 84878015575     PISSN: 21624011     EISSN: 2162402X     Source Type: Journal    
DOI: 10.4161/onci.19268     Document Type: Article

References (42)

1. Lesterhuis WJ, Haanen JB, Punt CJ. Cancer immunotherapy-revisited. Nat Rev Drug Discov 2011; 10:591-600; http://dx.doi.org/10.1038/nrd3500
2. Parish CR. Cancer immunotherapy: the past, the present and the future. Immunol Cell Biol 2003; 81:106-13; http://dx.doi.org/10.1046/j.0818-9641.2003.01151.x
3. Goldman B, DeFrancesco L. The cancer vaccine roller coaster. Nat Biotechnol 2009; 27:129-39; http://dx.doi.org/10.1038/nbt0209-129
4. Hoos A, Britten CM, Huber C, O'Donnell-Tormey J. A methodological framework to enhance the clinical success of cancer immunotherapy. Nat Biotechnol 2011; 29:867-70; http://dx.doi.org/10.1038/nbt.2000
5. Hoos A, Parmiani G, Hege K, Sznol M, Loibner H, Eggermont A, et al. A clinical development paradigm for cancer vaccines and related biologics. J Immunother 1997; 30:1-15.
6. Finke LH, Wentworth K, Blumenstein B, Rudolph NS, Levitsky H, Hoos A. Lessons from randomized phase III studies with active cancer immunotherapies-outcomes from the 2006 meeting of the Cancer Vaccine Consortium (CVC). Vaccine 2007; 25(Suppl 2): B97-109; http://dx.doi.org/10.1016/j.vaccine.2007.06.067
7. Britten CM, Janetzki S, van der Burg SH, Gouttefangeas C, Hoos A. Toward the harmonization of immune monitoring in clinical trials: quo vadis? Cancer Immunol Immunother 2008; 57:285-8; http://dx.doi.org/10.1007/s00262-007-0379-z
8. van der Burg SH, Kalos M, Gouttefangeas C, Janetzki S, Ottensmeier C, Welters MJ, et al. Harmonization of immune biomarker assays for clinical studies. Sci Transl Med 2011; 3:108ps44.
9. Hoos A, Eggermont AM, Janetzki S, Hodi FS, Ibrahim R, Anderson A, et al. Improved endpoints for cancer immunotherapy trials. J Natl Cancer Inst 2010; 102: 1388-97; http://dx.doi.org/10.1093/jnci/djq310
10. Wolchok JD, Hoos A, O'Day S, Weber JS, Hamid O, Lebbé C, et al. Guidelines for the evaluation of immune therapy activity in solid tumors: immune-related response criteria. Clin Cancer Res 2009; 15:7412-20; http://dx.doi.org/10.1158/1078-0432.CCR-09-1624
11. Janetzki S, Britten CM, Kalos M, Levitsky HI, Maecker HT, Melief CJ, et al. "MIATA"-minimal information about T cell assays. Immunity 2009; 31:527-8; http://dx.doi.org/10.1016/j.immuni.2009.09.007
12. Britten CM, Janetzki S, van der Burg SH, Huber C, Kalos M, Levitsky HI, et al. Minimal information about T cell assays: the process of reaching the community of T cell immunologists in cancer and beyond. Cancer Immunol Immunother 2011; 60:15-22; http://dx.doi.org/10.1007/s00262-010-0940-z
13. Guidance for industry: Clinical Considerations for Therapeutic Cancer Vaccines. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, September 2009. http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRe gulatoryInformation/Guidances/Vaccines/UCM182826.pdf.
14. Concept paper on the need to revise the guideline on the evaluation of anticancer medicinal products in man. European Medicines Agency. July 2010. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guidelin e/2010/09/WC500096730.pdf.
15. Kantoff PW, Higano CS, Shore ND, Berger ER, Small EJ, Penson DF, et al. IMPACT Study Investigators. Sipuleucel-T immunotherapy for castration-resistant prostate cancer. N Engl J Med 2010; 363:411-22; http://dx.doi.org/10.1056/NEJMoa1001294
16. Hodi FS, O'Day SJ, McDermott DF, Weber RW, Sosman JA, Haanen JB, et al. Improved survival with ipilimumab in patients with metastatic melanoma. N Engl J Med 2010; 363:711-23; http://dx.doi.org/10.1056/NEJMoa1003466
17. Hoos A, Ibrahim R, Korman A, Abdallah K, Berman D, Shahabi V, et al. Development of ipilimumab: contribution to a new paradigm for cancer immunotherapy. Semin Oncol 2010; 37:533-46; http://dx.doi.org/10.1053/j.seminoncol.2010.09.015
18. Hanahan D, Weinberg RA. The hallmarks of cancer. Cell 2000; 100:57-70; http://dx.doi.org/10.1016/S0092-8674(00)81683-9
19. Hanahan D, Weinberg RA. Hallmarks of cancer: the next generation. Cell 2011; 144:646-74; http://dx.doi.org/10.1016/j.cell.2011.02.013
20. Dunn GP, Bruce AT, Ikeda H, Old LJ, Schreiber RD. Cancer immunoediting: from immunosurveillance to tumor escape. Nat Immunol 2002; 3:991-8; http://dx.doi.org/10.1038/ni1102-991
21. Fine GD. Consequences of Delayed Treatment Effects on Analysis of Time-to-Event Endpoints. Drug Inf J 2007; 41:535-9.
22. WHO handbook for reporting results of cancer treatment. Geneva (Switzerland): World Health Organization Offset Publication No. 48, 1979.
23. Eisenhauer EA, Therasse P, Bogaerts J, Schwartz LH, Sargent D, Ford R, et al. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer 2009; 45:228-47; http://dx.doi.org/10.1016/j.ejca.2008.10.026
24. Ribas A, Chmielowski B, Glaspy JA. Do we need a different set of response assessment criteria for tumor immunotherapy? Clin Cancer Res 2009; 15:7116-8; http://dx.doi.org/10.1158/1078-0432.CCR-09-2376
25. Kruit WH, van Ojik HH, Brichard VG, Escudier B, Dorval T, Dréno B, et al. Phase 1/2 study of subcutaneous and intradermal immunization with a recombinant MAGE-3 protein in patients with detectable metastatic melanoma. Int J Cancer 2005; 117:596-604; http://dx.doi.org/10.1002/ijc.21264
26. van Baren N, Bonnet MC, Dréno B, Khammari A, Dorval T, Piperno-Neumann S, et al. Tumoral and immunologic response after vaccination of melanoma patients with an ALVAC virus encoding MAGE antigens recognized by T cells. J Clin Oncol 2005; 23:9008-21; http://dx.doi.org/10.1200/JCO.2005.08.375
27. Wagner JA. Overview of biomarkers and surrogate endpoints in drug development. Dis Markers 2002; 18:41-6
28. Janetzki S, Panageas KS, Ben-Porat L, Boyer J, Britten CM, Clay TM, et al. Elispot Proficiency Panel of the CVC Immune Assay Working Group. Results and harmonization guidelines from two large-scale international Elispot proficiency panels conducted by the Cancer Vaccine Consortium (CVC/SVI). Cancer Immunol Immunother 2008; 57:303-15; http://dx.doi.org/10.1007/s00262-007-0380-6
29. Britten CM, Gouttefangeas C, Welters MJ, Pawelec G, Koch S, Ottensmeier C, et al. The CIMT-monitoring panel: a two-step approach to harmonize the enumeration of antigen-specific CD8+ T lymphocytes by structural and functional assays. Cancer Immunol Immunother 2008; 57:289-302; http://dx.doi.org/10.1007/s00262-007-0378-0
30. Britten CM, Janetzki S, Ben-Porat L, Clay TM, Kalos M, Maecker H, et al. HLA-peptide Multimer Proficiency Panel of the CVC-CRI Immune Assay Working Group. Harmonization guidelines for HLApeptide multimer assays derived from results of a large scale international proficiency panel of the Cancer Vaccine Consortium. Cancer Immunol Immunother 2009; 58:1701-13; http://dx.doi.org/10.1007/s00262-009-0681-z
31. Attig S, Price L, Janetzki S, Kalos M, Pride M, McNeil L, et al. CRI-CIC Assay Working Group. A critical assessment for the value of markers to gate-out undesired events in HLA-peptide multimer staining protocols. J Transl Med 2011; 9:108; http://dx.doi.org/10.1186/1479-5876-9-108
32. Mander A, Gouttefangeas C, Ottensmeier C, Welters MJ, Low L, van der Burg SH, et al. Serum is not required for ex vivo IFN-gamma ELISPOT: a collaborative study of different protocols from the European CIMT Immunoguiding Program. Cancer Immunol Immunother 2010; 59:619-27; http://dx.doi.org/10.1007/s00262-009-0814-4
33. Moodie Z, Price L, Gouttefangeas C, Mander A, Janetzki S, Löwer M, et al. Response definition criteria for ELISPOT assays revisited. Cancer Immunol Immunother 2010; 59:1489-501; http://dx.doi.org/10.1007/s00262-010-0875-4
34. Janetzki S, Britten CM. The impact of harmonization on ELISPOT assay performance. Methods Mol Biol 2012; 792:25-36; http://dx.doi.org/ 10.1007/978-1-61779-325-7_2
35. Ich harmonised tripartite guideline: guideline for good clinical practice. E6(R1). 1996. http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Eff icacy/E6_R1/Step4/E6_R1__Guideline.pdf.
36. van der Burg SH. Therapeutic vaccines in cancer: moving from immunomonitoring to immunoguiding. Expert Rev Vaccines 2008; 7:1-5; http://dx.doi.org/10.1586/14760584.7.1.1
37. Taylor CF, Field D, Sansone SA, Aerts J, Apweiler R, Ashburner M, et al. Promoting coherent minimum reporting guidelines for biological and biomedical investigations: the MIBBI project. Nat Biotechnol 2008; 26:889-96; http://dx.doi.org/10.1038/nbt.1411
38. Ribas A, Hauschild A, Kefford R, Punt CJA, Haanen JB. Phase III open-label, randomized, cmparative study of tremelimumab (CP-675,206) and chemotherapy (temozolomide [TMZ] or dacarbazine [DTIC]) in patients with advanced melanoma. American Society of Clinical Oncology, Annual Meeting 2008, abstract LBA 9011.
39. Marshall M, Ribas A, Huang B. Evaluation of baseline serum C-reactive protein and benefit from tremelimumab compared to chemotherapy in first-line melanoma. American Society of Clinical Oncology, Annual Meeting, abstract 2609.
40. BMS press release: Bristol-Myers Squibb to Acquire Medarex. July 22, 2009. http://www.bms.com/news/press_releases/pages/default.aspx.
41. Finn OJ. Cancer immunology. N Engl J Med 2008; 358:2704-15; http://dx.doi.org/10.1056/NEJMra072739
42. Ribas A, Butterfield LH, Glaspy JA, Economou JS. Current developments in cancer vaccines and cellular immunotherapy. J Clin Oncol 2003; 21:2415-32; http://dx.doi.org/10.1200/JCO.2003.06.041