Talimogene laherparepvec in combination with ipilimumab in previously untreated, unresectable stage IIIB-IV melanoma

Journal of Clinical Oncology

Volumn 34, Issue 22, 2016, Pages 2619-2626

  Puzanov, Igor ^a,h   Milhem, Mohammed M ^b   Minor, David ^c   Hamid, Omid ^d   Li, Ai ^e   Chen, Lisa ^e   Chastain, Michael ^e   Gorski, Kevin S ^e   Anderson, Abraham ^e   Chou, Jeffrey ^e   Kaufman, Howard L ^f   Andtbacka, Robert H I ^g  

^a VANDERBILT UNIVERSITY   (United States)

^b UNIVERSITY OF IOWA   (United States)

^c California Pacific Center for Melanoma Research and Treatment   (United States)

^d Angeles Clinic and Research Institute   (United States)

^e AMGEN INC   (United States)

^f RUTGERS CANCER INSTITUTE OF NEW JERSEY   (United States)

^g UNIVERSITY OF UTAH   (United States)

^h VANDERBILT UNIVERSITY MEDICAL CENTER   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

AMYLASE; INDUCIBLE T CELL COSTIMULATOR; IPILIMUMAB; TALIMOGENE LAHERPAREPVEC; TRIACYLGLYCEROL LIPASE; MONOCLONAL ANTIBODY; ONCOLYTIC VIRUS;

ADULT; AGED; BACKACHE; BLURRED VISION; CANCER COMBINATION CHEMOTHERAPY; CANCER IMMUNOTHERAPY; CANCER STAGING; CANCER SURVIVAL; CD3+ T LYMPHOCYTE; CD8+ T LYMPHOCYTE; CHILL; CLINICAL ARTICLE; CONFERENCE PAPER; CONTROLLED STUDY; DEHYDRATION; DIARRHEA; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; ERYTHEMA; FATIGUE; FEMALE; FEVER; FLU LIKE SYNDROME; HEADACHE; HUMAN; HUMAN CELL; HYPOKALEMIA; INJECTION SITE REACTION; INOPERABLE CANCER; MALE; MELANOMA; MULTICENTER STUDY; MYCOSIS; NAUSEA; NIGHT SWEAT; OPEN STUDY; OUTCOME ASSESSMENT; OVERALL SURVIVAL; PAIN; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; PRURITUS; RANDOMIZED CONTROLLED TRIAL; RASH; SURVIVAL RATE; SURVIVAL TIME; T LYMPHOCYTE SUBPOPULATION; TREATMENT DURATION; TREATMENT RESPONSE; VOMITING; VULVOVAGINAL DISEASE; ADVERSE EFFECTS; CLINICAL TRIAL; IMMUNOLOGY; MIDDLE AGED; ONCOLYTIC VIROTHERAPY; PHASE 4 CLINICAL TRIAL; PROCEDURES; SKIN NEOPLASMS; TUMOR VOLUME; VERY ELDERLY;

ADULT; AGED; AGED, 80 AND OVER; ANTIBODIES, MONOCLONAL; FEMALE; HUMANS; MALE; MELANOMA; MIDDLE AGED; ONCOLYTIC VIROTHERAPY; ONCOLYTIC VIRUSES; SKIN NEOPLASMS; T-LYMPHOCYTE SUBSETS; TUMOR BURDEN;

EID: 84979599378     PISSN: 0732183X     EISSN: 15277755     Source Type: Journal    
DOI: 10.1200/JCO.2016.67.1529     Document Type: Conference Paper

References (32)

1. Hanahan D, Weinberg RA: Hallmarks of cancer: The next generation. Cell 144:646-674, 2011
2. Raval RR, Sharabi AB, Walker AJ, et al: Tumor immunology and cancer immunotherapy: Summary of the 2013 SITC primer. J Immunother Cancer 2:14, 2014
3. Hannani D, Vétizou M, Enot D, et al: Anticancer immunotherapy by CTLA-4 blockade: obligatory contribution of IL-2 receptors and negative prognostic impact of soluble CD25. Cell Res 25: 208-224, 2015 [Erratum: Cell Res 25:399-400, 2015]
4. Kohlhapp FJ, Broucek JR, Hughes T, et al: NK cells and CD8+ T cells cooperate to improve therapeutic responses in melanoma treated with interleukin-2 (IL-2) and CTLA-4 blockade. J Immunother Cancer 3:18, 2015
5. van Elsas A, Hurwitz AA, Allison JP: Combination immunotherapy of B16 melanoma using anticytotoxic T lymphocyte-associated antigen 4 (CTLA-4) and granulocyte/macrophage colony-stimulating factor (GM-CSF)-producing vaccines induces rejection of subcutaneous and metastatic tumors accompanied by autoimmune depigmentation. J Exp Med 190:355-366, 1999
6. Pardoll DM: The blockade of immune checkpoints in cancer immunotherapy. Nat Rev Cancer 12: 252-264, 2012
7. Tarhini AA, Edington H, Butterfield LH, et al: Immune monitoring of the circulation and the tumor microenvironment in patients with regionally advanced melanoma receiving neoadjuvant ipilimumab. PLoS One 9:e87705, 2014
8. Fong L, Kwek SS, O'Brien S, et al: Potentiating endogenous antitumor immunity to prostate cancer through combination immunotherapy with CTLA4 blockade and GM-CSF. Cancer Res 69: 609-615, 2009
9. Weber J: Ipilimumab: Controversies in its development, utility and autoimmune adverse events. Cancer Immunol Immunother 58:823-830, 2009
10. Kapadia D, Fong L: CTLA-4 blockade: Autoimmunity as treatment. J Clin Oncol 23:8926-8928, 2005
11. McDermott DF, Atkins MB: PD-1 as a potential target in cancer therapy. Cancer Med 2:662-673, 2013
12. Hodi FS, O'Day SJ, McDermott DF, et al: Improved survival with ipilimumab in patients with metastatic melanoma. N Engl J Med 363:711-723, 2010
13. Larkin J, Chiarion-Sileni V, Gonzalez R, et al: Combined nivolumab and ipilimumab or monotherapy in untreated melanoma. N Engl J Med 373: 23-34, 2015
14. Robert C, Thomas L, Bondarenko I, et al: Ipilimumab plus dacarbazine for previously untreated metastatic melanoma. N Engl J Med 364:2517-2526, 2011
15. Liu BL, Robinson M, Han ZQ, et al: ICP34.5 deleted herpes simplex virus with enhanced oncolytic, immune stimulating, and anti-tumour properties. Gene Ther 10:292-303, 2003
16. Conti L, Gessani S: GM-CSF in the generation of dendritic cells from human blood monocyte precursors: Recent advances. Immunobiology 213: 859-870, 2008
17. Demir G, Klein HO, Tuzuner N: Low dose daily rhGM-CSF application activates monocytes and dendritic cells in vivo. Leuk Res 27:1105-1108, 2003
18. Lonial S: Immunomodulation: The role of hematopoietic cytokines. Support Cancer Ther 1:80-88, 2004
19. Kaufman HL, Ruby CE, Hughes T, et al: Current status of granulocyte-macrophage colonystimulating factor in the immunotherapy of melanoma. J Immunother Cancer 2:11, 2014
20. Kaufman HL, Kim DW, De Raffele G, et al: Local and distant immunity induced by intralesional vaccination with an oncolytic herpes virus encoding GM-CSF in patients with stage IIIc and IV melanoma. Ann Surg Oncol 17:718-730, 2010
21. Hodi FS, Lee S, McDermott DF, et al: Ipilimumab plus sargramostim vs ipilimumab alone for treatment of metastatic melanoma: A randomized clinical trial. JAMA 312:1744-1753, 2014
22. Andtbacka RH, Kaufman HL, Collichio F, et al: Talimogene laherparepvec improves durable response rate in patients with advanced melanoma. J Clin Oncol 33:2780-2788, 2015
23. Wolchok JD, Hoos A, O'Day S, et al: Guidelines for the evaluation of immune therapy activity in solid tumors: Immune-related response criteria. Clin Cancer Res 15:7412-7420, 2009
24. Benjamini Y, Hochberg Y: Controlling the false discovery rate: A practical and powerful approach to multiple testing. JR Stat Soc 57:289-300, 1995
25. Attia P, Phan GQ, Maker AV, et al: Autoimmunity correlates with tumor regression in patients with metastatic melanoma treated with anti-cytotoxic T-lymphocyte antigen-4. J Clin Oncol 23:6043-6053, 2005
26. Carthon BC, Wolchok JD, Yuan J, et al: Preoperative CTLA-4 blockade: Tolerability and immune monitoring in the setting of a presurgical clinical trial. Clin Cancer Res 16:2861-2871, 2010
27. Maker AV, Phan GQ, Attia P, et al: Tumor regression and autoimmunity in patients treated with cytotoxic T lymphocyte-associated antigen 4 blockade and interleukin 2: A phase I/II study. Ann Surg Oncol 12:1005-1016, 2005
28. Phan GQ, Yang JC, Sherry RM, et al: Cancer regression and autoimmunity induced by cytotoxic T lymphocyte-associated antigen 4 blockade in patients with metastatic melanoma. Proc Natl Acad Sci USA 100:8372-8377, 2003
29. Weber JS, Hamid O, Chasalow SD, et al: Ipilimumab increases activated T cells and enhances humoral immunity in patients with advanced melanoma. J Immunother 35:89-97, 2012
30. Snyder A, Wolchok JD, Chan TA: Genetic basis for clinical response to CTLA-4 blockade. N Engl J Med 372:783, 2015
31. Van Allen EM, Miao D, Schilling B, et al: Genomic correlates of response to CTLA-4 blockade in metastatic melanoma. Science 350:207-211, 2015
32. Long GV, Drummer R, Ribas A, et al: Primary analysis of MASTERKEY-265 phase 1b study of talimogene laherparepvec (T-VEC) and pembrolizumab (pembro) for unresectable stage IIIB-IV melanoma. Presented at Society for Melanoma Congress, San Francisco, CA, Nov 16-21, 2015