Personalized immunotherapy (AGS-003) when combined with sunitinib for the treatment of metastatic renal cell carcinoma

Bibliography

• Siegel RL, Miller KD, Jemal A. Cancer statistics, 2015. CA 2015;65(1):5-29
   Google Scholar
• GLOBOCAN. Kidney–estimated cancer incidence, all ages: both sexes. Int Agency Res Cancer 2012
   Google Scholar
• National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology: Kidney Cancer. National Comprehensive Cancer Network, Inc. 2015
   Google Scholar
• Jonasch E, Gao J, Rathmell WK. Renal cell carcinoma. Bmj 2014;349:g4797
   PubMed Web of Science ®Google Scholar
• Belldegrun A, Muul LM, Rosenberg SA. Interleukin 2 expanded tumor-infiltrating lymphocytes in human renal cell cancer: isolation, characterization, and antitumor activity. Cancer Res 1988;48(1):206-14
   PubMed Web of Science ®Google Scholar
• Thurnher M, Radmayr C, Ramoner R, et al. Human renal-cell carcinoma tissue contains dendritic cells. Int J Cancer 1996;68(1):1-7
   PubMed Web of Science ®Google Scholar
• Rosenberg SA, Lotze MT, Muul LM, et al. A progress report on the treatment of 157 patients with advanced cancer using lymphokine-activated killer cells and interleukin-2 or high-dose interleukin-2 alone. N Eng J Med 1987;316(15):889-97
   PubMed Web of Science ®Google Scholar
• Motzer RJ, Bacik J, Murphy BA, et al. Interferon-alfa as a comparative treatment for clinical trials of new therapies against advanced renal cell carcinoma. J Clin Oncol 2002;20(1):289-96
   PubMed Web of Science ®Google Scholar
• George S, Pili R, Carducci MA, Kim JJ. Role of immunotherapy for renal cell cancer in 2011. J Natl Comprehens Cancer Net 2011;9(9):1011-18
   PubMed Web of Science ®Google Scholar
• Fyfe G, Fisher RI, Rosenberg SA, et al. Results of treatment of 255 patients with metastatic renal cell carcinoma who received high-dose recombinant interleukin-2 therapy. J Clin Oncology 1995;13(3):688-96
   PubMed Web of Science ®Google Scholar
• Atkins MB. Treatment selection for patients with metastatic renal cell carcinoma: identification of features favoring upfront IL-2-based immunotherapy. Med Oncol 2009;26(Suppl 1):18-22
   PubMed Web of Science ®Google Scholar
• Motzer RJ, Hutson TE, Tomczak P, et al. Sunitinib versus interferon alfa in metastatic renal-cell carcinoma. N Eng J Med 2007;356(2):115-24
   PubMed Web of Science ®Google Scholar
• McDermott DF. Immunotherapy of metastatic renal cell carcinoma. Cancer 2009;115(10 Suppl):2298-305
   PubMed Web of Science ®Google Scholar
• Hutson TE. Targeted therapies for the treatment of metastatic renal cell carcinoma: clinical evidence. Oncologist 2011;16(Suppl 2):14-22
   PubMed Web of Science ®Google Scholar
• Sun M, Lughezzani G, Perrotte P, Karakiewicz PI. Treatment of metastatic renal cell carcinoma. Nat Rev Urol 2010;7(6):327-38
   PubMed Web of Science ®Google Scholar
• Topalian SL, Drake CG, Pardoll DM. Targeting the PD-1/B7-H1(PD-L1) pathway to activate anti-tumor immunity. Curr Opin Immunol 2012;24(2):207-12
   PubMed Web of Science ®Google Scholar
• Motzer RJ, Rini BI, McDermott DF, et al. Nivolumab for Metastatic Renal Cell Carcinoma: Results of a Randomized Phase II Trial. J Clin Oncol 2015;33(13):1430-7
   PubMed Web of Science ®Google Scholar
• NCT01265901. A Randomized, Controlled Phase III Study Investigating IMA901 Multipeptide Cancer Vaccine in Patients Receiving Sunitinib as First-line Therapy for Advanced/Metastatic Renal Cell Carcinoma. Available from: http://www.clinicaltrials.gov/ct2/show/NCT01265901 [Cited 1 May 2015]
   Google Scholar
• NCT01668784. A Randomized, Open-Label, Phase 3 Study of Nivolumab (BMS-936558) vs. Everolimus in Subjects With Advanced or Metastatic Clear-Cell Renal Cell Carcinoma Who Have Received Prior Anti-Angiogenic Therapy. Available from: https://www.clinicaltrials.gov/ct2/show/NCT01668784 [Cited 1 May 2015]
   Google Scholar
• Cohen S, Kaufman HL. TG-4010 Transgene. Curr Opin Investig Drugs 2004;5(12):1319-28
   PubMedGoogle Scholar
• Rochlitz C, Figlin R, Squiban P, et al. Phase I immunotherapy with a modified vaccinia virus (MVA) expressing human MUC1 as antigen-specific immunotherapy in patients with MUC1-positive advanced cancer. J Gene Med 2003;5(8):690-9
   PubMed Web of Science ®Google Scholar
• Oudard S, Rixe O, Beuselinck B, et al. A phase II study of the cancer vaccine TG4010 alone and in combination with cytokines in patients with metastatic renal clear-cell carcinoma: clinical and immunological findings. Cancer Immunol Immunother 2011;60(2):261-71
   PubMed Web of Science ®Google Scholar
• NCT01383148. A Phase IIB/III Randomized, Double-blind, Placebo Controlled Study Comparing First Line Therapy With or Without TG4010 Immunotherapy Product in Patients With Stage IV Non-Small Cell Lung Cancer (NSCLC). Available from: http://www.clinicaltrials.gov/ct2/show/NCT01383148 [Cited 1 May 2015]
   Google Scholar
• Southall PJ, Boxer GM, Bagshawe KD, et al. Immunohistological distribution of 5T4 antigen in normal and malignant tissues. Br J Cancer 1990;61(1):89-95
   PubMed Web of Science ®Google Scholar
• Amato RJ, Hawkins RE, Kaufman HL, et al. Vaccination of metastatic renal cancer patients with MVA-5T4: a randomized, double-blind, placebo-controlled phase III study. Clin Cancer Res 2010;16(22):5539-47
   PubMed Web of Science ®Google Scholar
• Pilla L, Rivoltini L, Patuzzo R, et al. Multipeptide vaccination in cancer patients. Expert Opin Biol Ther 2009;9(8):1043-55
   PubMed Web of Science ®Google Scholar
• Walter S, Weinschenk T, Stenzl A, et al. Multipeptide immune response to cancer vaccine IMA901 after single-dose cyclophosphamide associates with longer patient survival. Nat Med 2012;18(8):1254-61
   PubMed Web of Science ®Google Scholar
• Walter S, Weinschenk T, Reinhardt C, Singh-Jasuja H. Single-dose cyclophosphamide synergizes with immune responses to the renal cell cancer vaccine IMA901. Oncoimmunology 2013;2(1):e22246
   PubMed Web of Science ®Google Scholar
• Eggermont AM. Can immuno-oncology offer a truly pan-tumour approach to therapy? Annals Oncol 2012;23(Suppl 8):viii53-7
   PubMedGoogle Scholar
• Kalinski P, Muthuswamy R, Urban J. Dendritic cells in cancer immunotherapy: vaccines and combination immunotherapies. Expert Rev Vaccines 2013;12(3):285-95
   PubMed Web of Science ®Google Scholar
• Kantoff PW, Higano CS, Shore ND, et al. Sipuleucel-T immunotherapy for castration-resistant prostate cancer. N Eng J Med 2010;363(5):411-22
   PubMed Web of Science ®Google Scholar
• Dendreon Corporation. PROVENGE (sipuleucel-T) Prescribing Information. 2010. Available from: http://www.fda.gov/downloads/BiologicsBloodVaccines/CellularGeneTherapyProducts/ApprovedProducts/UCM210031.pdf [Cited 1 May 2015]
   Google Scholar
• Banchereau J, Paczesny S, Blanco P, et al. Dendritic cells: controllers of the immune system and a new promise for immunotherapy. Ann N Y Acad Sci 2003;987:180-7
   PubMed Web of Science ®Google Scholar
• Tacken PJ, de Vries IJ, Torensma R, Figdor CG. Dendritic-cell immunotherapy: from ex vivo loading to in vivo targeting. Nat Rev Immunol 2007;7(10):790-802
   PubMed Web of Science ®Google Scholar
• Yanofsky VR, Mitsui H, Felsen D, Carucci JA. Understanding dendritic cells and their role in cutaneous carcinoma and cancer immunotherapy. Clin Dev Immunol 2013;2013:624123
   PubMedGoogle Scholar
• Coates PT, Colvin BL, Hackstein H, Thomson AW. Manipulation of dendritic cells as an approach to improved outcomes in transplantation. Expert Rev Mol Med 2002;4(3):1-21
   PubMedGoogle Scholar
• DeBenedette MA, Calderhead DM, Tcherepanova IY, et al. Potency of mature CD40L RNA electroporated dendritic cells correlates with IL-12 secretion by tracking multifunctional CD8(+)/CD28(+) cytotoxic T-cell responses in vitro. J Immunotherapy 2011;34(1):45-57
   PubMed Web of Science ®Google Scholar
• Calderhead DM, DeBenedette MA, Ketteringham H, et al. Cytokine maturation followed by CD40L mRNA electroporation results in a clinically relevant dendritic cell product capable of inducing a potent proinflammatory CTL response. J Immunother 2008;31(8):731-41
   PubMed Web of Science ®Google Scholar
• DeBenedette MA, Calderhead DM, Ketteringham H, et al. Priming of a novel subset of CD28+ rapidly expanding high-avidity effector memory CTL by post maturation electroporation-CD40L dendritic cells is IL-12 dependent. J Immunol 2008;181(8):5296-305
   PubMed Web of Science ®Google Scholar
• Amin A, Dudek AZ, Logan TF, et al. Survival with AGS-003, an autologous dendritic cell-based immunotherapy, in combination with sunitinib in unfavorable risk patients with advanced renal cell carcinoma (RCC): Phase 2 study results. J Immunother Cancer 2015;3:14
   PubMed Web of Science ®Google Scholar
• Figlin RA, Nicolette CA, Amin A, et al. Monitoring T-cell responses in a phase II study of AGS-003, an autologous dendritic cell-based therapy in patients with newly diagnosed advanced stage renal cell carcinoma in combination with sunitinib. J Clin Oncol 2011;29(Suppl):abstract 2532
   Google Scholar
• Finke JH, Rini B, Ireland J, et al. Sunitinib reverses type-1 immune suppression and decreases T-regulatory cells in renal cell carcinoma patients. Clin Cancer Res 2008;14(20):6674-82
   PubMed Web of Science ®Google Scholar
• Hipp MM, Hilf N, Walter S, et al. Sorafenib, but not sunitinib, affects function of dendritic cells and induction of primary immune responses. Blood 2008;111(12):5610-20
   PubMed Web of Science ®Google Scholar
• Logan T, Amin A, Cohen V, et al. A phase 1/2 study of AGS-003, a personalized immunotherapeutic evaluated in newly diagnosed metastatic renal cell carcinoma subjects [abstract #379]. ASCO 2010 Genitourinary Cancers Symposium; March 5-7, 2010; San Francisco, CA
   Google Scholar
• Heng DY, Xie W, Regan MM, et al. Prognostic factors for overall survival in patients with metastatic renal cell carcinoma treated with vascular endothelial growth factor-targeted agents: results from a large, multicenter study. J Clin Oncol 2009;27(34):5794-9
   PubMed Web of Science ®Google Scholar
• NCT01582672. An International Phase 3 Randomized Trial of Autologous Dendritic Cell Immunotherapy (AGS-003) Plus Standard Treatment of Advanced Renal Cell Carcinoma (ADAPT). Available from: http://www.clinicaltrials.gov/ct2/show/NCT01582672 [Cited 1 May 2015]
   Google Scholar
• Figlin RA, Wood C. Patient Identification and Eligibility Insights in the Synchronous Metastatic RCC Population: an update from the ongoing ADAPT phase 3 study experience. J Clin Oncol 2015;33(Suppl):abstract TPS4582
   Google Scholar
• Cella D, Davis MP, Negrier S, et al. Characterizing fatigue associated with sunitinib and its impact on health-related quality of life in patients with metastatic renal cell carcinoma. Cancer 2014;120(12):1871-80
   PubMed Web of Science ®Google Scholar
• Kollmannsberger C, Bjarnason G, Burnett P, et al. Sunitinib in metastatic renal cell carcinoma: recommendations for management of noncardiovascular toxicities. Oncologist 2011;16(5):543-53
   PubMed Web of Science ®Google Scholar
• Motzer RJ, Hutson TE, Tomczak P, et al. Overall survival and updated results for sunitinib compared with interferon alfa in patients with metastatic renal cell carcinoma. J Clin Oncol 2009;27(22):3584-90
   PubMed Web of Science ®Google Scholar
• Escudier B, Pluzanska A, Koralewski P, et al. Bevacizumab plus interferon alfa-2a for treatment of metastatic renal cell carcinoma: a randomised, double-blind phase III trial. Lancet 2007;370(9605):2103-11
   PubMed Web of Science ®Google Scholar
• Rini BI, Escudier B, Tomczak P, et al. Comparative effectiveness of axitinib versus sorafenib in advanced renal cell carcinoma (AXIS): a randomised phase 3 trial. Lancet 2011;378(9807):1931-9
   PubMed Web of Science ®Google Scholar
• Sternberg CN, Davis ID, Mardiak J, et al. Pazopanib in locally advanced or metastatic renal cell carcinoma: results of a randomized phase III trial. J Clin Oncol 2010;28(6):1061-8
   PubMed Web of Science ®Google Scholar
• Motzer RJ, Escudier B, Oudard S, et al. Efficacy of everolimus in advanced renal cell carcinoma: a double-blind, randomised, placebo-controlled phase III trial. Lancet 2008;372(9637):449-56
   PubMed Web of Science ®Google Scholar
• Escudier B, Eisen T, Stadler WM, et al. Sorafenib in advanced clear-cell renal-cell carcinoma. N Eng J Med 2007;356(2):125-34
   PubMed Web of Science ®Google Scholar
• Hudes G, Carducci M, Tomczak P, et al. Temsirolimus, interferon alfa, or both for advanced renal-cell carcinoma. N Eng J Med 2007;356(22):2271-81
   PubMed Web of Science ®Google Scholar
• Rini BI, Bellmunt J, Clancy J, et al. Randomized phase III trial of temsirolimus and bevacizumab versus interferon alfa and bevacizumab in metastatic renal cell carcinoma: INTORACT trial. J Clin Oncol 2014;32(8):752-9
   PubMed Web of Science ®Google Scholar
• Patel PH, Senico PL, Curiel RE, Motzer RJ. Phase I study combining treatment with temsirolimus and sunitinib malate in patients with advanced renal cell carcinoma. Clin Genitourin Cancer 2009;7(1):24-7
   PubMed Web of Science ®Google Scholar
• Molina AM, Feldman DR, Voss MH, et al. Phase 1 trial of everolimus plus sunitinib in patients with metastatic renal cell carcinoma. Cancer 2012;118(7):1868-76
   PubMed Web of Science ®Google Scholar
• Feldman DR, Baum MS, Ginsberg MS, et al. Phase I trial of bevacizumab plus escalated doses of sunitinib in patients with metastatic renal cell carcinoma. J Clin Oncol 2009;27(9):1432-9
   PubMed Web of Science ®Google Scholar
• Ko JJ, Choueiri TK, Rini BI, et al. First-, second-, third-line therapy for mRCC: benchmarks for trial design from the IMDC. Br J Cancer 2014;110(8):1917-22
   PubMed Web of Science ®Google Scholar
• Xin H, Zhang C, Herrmann A, et al. Sunitinib inhibition of Stat3 induces renal cell carcinoma tumor cell apoptosis and reduces immunosuppressive cells. Cancer Res 2009;69(6):2506-13
   PubMed Web of Science ®Google Scholar
• Farsaci B, Higgins JP, Hodge JW. Consequence of dose scheduling of sunitinib on host immune response elements and vaccine combination therapy. Int J Cancer 2012;130(8):1948-59
   PubMed Web of Science ®Google Scholar
• Bose A, Taylor JL, Alber S, et al. Sunitinib facilitates the activation and recruitment of therapeutic anti-tumor immunity in concert with specific vaccination. Int J Cancer 2011;129(9):2158-70
   PubMed Web of Science ®Google Scholar
• Kirner A, Mayer-Mokler A, Reinhardt C. IMA901: a multi-peptide cancer vaccine for treatment of renal cell cancer. Hum Vaccin Immunother 2014;10(11):3179-89
   PubMed Web of Science ®Google Scholar
• Rausch S, Kruck S, Stenzl A, Bedke J. IMA901 for metastatic renal cell carcinoma in the context of new approaches to immunotherapy. Future Oncol 2014;10(6):937-48
   PubMed Web of Science ®Google Scholar
• NCT02452281. Phase I-II pilot study to evaluate the immune-mediated effects of an autologous tumor-derived heat shock protein-peptide complex 96 (HSPPC-96) combined with ipilimumab in patients with therapeutically unresectable Stage III or Stage IV malignant melanoma. Available from: https://www.clinicaltrials.gov/ct2/show/NCT02452281 [Cited 1 May 2015]
   Google Scholar
• NCT02070406. NY-ESO-1 TCR Engineered Adoptive Cell Transfer Therapy With CTLA4 Blockade. Available from: https://www.clinicaltrials.gov/ct2/show/NCT02070406 [Cited 1 May 2015]
   Google Scholar