Pembrolizumab for treatment of patients with advanced or unresectable melanoma

Clinical Cancer Research

Volumn 21, Issue 13, 2015, Pages 2892-2897

  Sullivan, Ryan J ^a   Flaherty, Keith T ^a  

^a MASSACHUSETTS GENERAL HOSPITAL CANCER CENTER   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ALPHA INTERFERON; CYTOTOXIC T LYMPHOCYTE ANTIGEN 4; INTERLEUKIN 12; IPILIMUMAB; MPDL 3280A; NIVOLUMAB; PEMBROLIZUMAB; PROGRAMMED DEATH 1 LIGAND 1; PROGRAMMED DEATH 1 LIGAND 2; PROGRAMMED DEATH 1 RECEPTOR; ANTINEOPLASTIC AGENT; MONOCLONAL ANTIBODY;

ADVANCED CANCER; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ANTIBODY DETECTION; ARTICLE; ASTHENIA; CANCER IMMUNOTHERAPY; CANCER SURVIVAL; CHILL; COHORT ANALYSIS; COLITIS; COUGHING; DECREASED APPETITE; DIARRHEA; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; FATIGUE; FEVER; HEADACHE; HEPATITIS; HUMAN; HYPOTHYROIDISM; IMMUNOGENICITY; IMMUNOREGULATION; LYMPHOCYTE ACTIVATION; MELANOMA; MYALGIA; NAUSEA; NONHUMAN; OVERALL SURVIVAL; PNEUMONIA; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; PROTEIN EXPRESSION; PROTEIN PURIFICATION; PRURITUS; RASH; SIDE EFFECT; SURVIVAL RATE; SURVIVAL TIME; TUMOR ASSOCIATED LEUKOCYTE; VITILIGO; CLINICAL TRIAL (TOPIC); IMMUNOTHERAPY; PATHOLOGY; PATIENT SELECTION; SECONDARY; SKIN NEOPLASMS;

ANTIBODIES, MONOCLONAL, HUMANIZED; ANTINEOPLASTIC AGENTS; CLINICAL TRIALS AS TOPIC; HUMANS; IMMUNOTHERAPY; MELANOMA; PATIENT SELECTION; SKIN NEOPLASMS;

EID: 84941961258     PISSN: 10780432     EISSN: 15573265     Source Type: Journal    
DOI: 10.1158/1078-0432.CCR-14-3061     Document Type: Article

References (32)

1. Coley WB. The treatment of inoperable sarcoma by bacterial toxins (the mixed toxins of the Streptococcus erysipelas and the Bacillus prodigiosus). Proc R Soc Med 1910;3:1-48.
2. Siegel RL, Miller KD, Jemal A. Cancer statistics, 2015. CA Cancer J Clin 2015;65:5-29.
3. Morton DL, Eilber FR, Holmes EC, Hunt JS, Ketcham AS, Silverstein MJ, et al. BCG immunotherapy of malignant melanoma: summary of a sevenyear experience. Ann Surg 1974;180:635-43.
4. Kirkwood JM, Manola J, Ibrahim J, Sondak V, Ernstoff MS, Rao U. A pooled analysis of eastern cooperative oncology group and intergroup trials of adjuvant high-dose interferon for melanoma. Clin Cancer Res 2004;10: 1670-7.
5. Atkins MB, Lotze MT, Dutcher JP, Fisher RI, Weiss G, Margolin K, et al. Highdose recombinant interleukin 2 therapy for patients with metastatic melanoma: Analysis of 270 patients treated between 1985 and 1993. J Clin Oncol 1999;17:2105-16.
6. Hodi FS, O'Day SJ, McDermott DF, Weber RW, Sosman JA, Haanen JB, et al. Improved survivalwith ipilimumab in patients with metastatic melanoma. N Engl J Med 2010;363:711-23.
7. Hauschild A, Grob JJ, Demidov LV, Jouary T, Gutzmer R, Millward M, et al. Dabrafenib in BRAF-mutated metastatic melanoma: A multicentre, open-label, phase 3 randomised controlled trial. Lancet 2012; 380:358-65.
8. Flaherty KT, Robert C, Hersey P, Nathan P, Garbe C, Milhem M, et al. Improved survival with MEK inhibition in BRAF-mutated melanoma. N Engl J Med 2012;367:107-14.
9. Flaherty KT, Infante JR, Daud A, Gonzalez R, Kefford RF, Sosman J, et al. Combined BRAF and MEK inhibition in melanoma with BRAF V600 mutations. N Engl J Med 2012;367:1694-703.
10. Robert C, Ribas A, Wolchok JD, Hodi FS, Hamid O, Kefford R, et al. Antiprogrammed-death-receptor-1 treatment with pembrolizumab in ipilimumab-refractory advanced melanoma: A randomised dose-comparison cohort of a phase 1 trial. Lancet 2014;384:1109-17.
11. Topalian SL, Sznol M, McDermott DF, Kluger HM, Carvajal RD, Sharfman WH, et al. Survival, durable tumor remission, and long-Term safety in patients with advanced melanoma receiving nivolumab. J Clin Oncol 2014;32:1020-30.
12. Tivol EA, Borriello F, Schweitzer AN, Lynch WP, Bluestone JA, Sharpe AH. Loss of CTLA-4 leads tomassive lymphoproliferation and fatal multiorgan tissue destruction, revealing a critical negative regulatory role of CTLA-4. Immunity 1995;3:541-7.
13. Nishimura H, Nose M, Hiai H, Minato N, Honjo T. Development of lupuslike autoimmune diseases by disruption of the PD-1 gene encoding an ITIM motif-carrying immunoreceptor. Immunity 1999;11:141-51.
14. Latchman YE, Liang SC, Wu Y, Chernova T, Sobel RA, Klemm M, et al. PDL1-deficientmice show that PD-L1 on T cells, antigen-presenting cells, and host tissues negatively regulates T cells. Proc Natl Acad Sci U S A 2004; 101:10691-6.
15. Leach DR, Krummel MF, Allison JP. Enhancement of antitumor immunity by CTLA-4 blockade. Science 1996;271:1734-6.
16. Hirano F, Kaneko K, Tamura H, Dong H, Wang S, Ichikawa M, et al. Blockade of B7-H1 and PD-1 by monoclonal antibodies potentiates cancer therapeutic immunity. Cancer Res 2005;65:1089-96.
17. Curran MA, Montalvo W, Yagita H, Allison JP. PD-1 and CTLA-4 combination blockade expands infiltrating T cells and reduces regulatory T and myeloid cells within B16 melanomatumors. Proc Natl Acad SciUS A2010; 107:4275-80.
18. Brahmer JR, Drake CG, Wollner I, Powderly JD, Picus J, Sharfman WH, et al. Phase I study of single-Agent anti-programmed death-1 (MDX-1106) in refractory solid tumors: safety, clinical activity, pharmacodynamics, and immunologic correlates. J Clin Oncol 2010;28:3167-75.
19. Topalian SL, Hodi FS, Brahmer JR, Gettinger SN, Smith DC, McDermott DF, et al. Safety, activity, and immune correlates of anti-PD-1 antibody in cancer. N Engl J Med 2012;366:2443-54.
20. Weber JS, Minor DR, D'Angelo SP, Hodi FS, Gutzmer R, Neyns B, et al. A phase 3 randomized, open-label study of nivolumab (anti-PD-1; BMS-936558; ONO-4538) versus investigator's choice chemotherapy (ICC) in patients with advanced melanoma after prior anti-CTLA-4 therapy [abstract]. In: Proceedings of the ESMO 2014 Congress; 2014 Sep 26-30, 2014; Madrid, Spain. Lugano (Switzerland): Eurpoean Society for Medical Oncology; 2014. Abstract nr LBA3 PR.
21. Hamid O, Robert C, Daud A, Hodi FS, Hwu WJ, Kefford R, et al. Safety and tumor responses with lambrolizumab (anti-PD-1) in melanoma. N Engl J Med 2013;369:134-44.
22. Weber JS, Kahler KC, Hauschild A. Management of immune-related adverse events and kinetics of response with ipilimumab. J Clin Oncol 2012;30:2691-7.
23. Atkins MB, Kunkel L, Sznol M, Rosenberg SA. High-dose recombinant interleukin-2 therapy in patients with metastatic melanoma: long-Term survival update. Cancer J Sci Am 2000;6 Suppl 1:S11-4.
24. Schadendorf D, Hodi FS, Robert C, Weber JS, Margolin K, Hamid O, et al. Pooled analysis of long-Term survival data from phase II and phase III trials of ipilimumab in unresectable or metastaticmelanoma. J Clin Oncol 2015 Feb 9. [Epub ahead of print].
25. Chapman PB, Hauschild A, Robert C, Haanen JB, Ascierto P, Larkin J, et al. Improved survival with vemurafenib in melanoma with BRAF V600E mutation. N Engl J Med 2011;364:2507-16.
26. Hamid O, Sosman J, Lawrence DP, Sullivan RJ, Ibrahim N, Kluger HM, et al. Clinical activity, safety, and biomarkers ofMPDL3280A, an engineered PDL1 antibody in patients with locally advanced or metastatic melanoma (mM). J Clin Oncol 31, 2013 (suppl; abstr 9010).
27. Flaherty KT, Puzanov I, Kim KB, Ribas A, McArthur GA, Sosman JA, et al. Inhibition of mutated, activated BRAF in metastatic melanoma. NEngl J of Med 2010;363:809-19.
28. Joseph RW, Sullivan RJ, Harrell R, Stemke-Hale K, Panka D, Manoukian G, et al. Correlation of NRAS mutations with clinical response to high-dose IL-2 in patients with advanced melanoma. J Immunother 2012;35:66-72.
29. Robert C, Thomas L, Bondarenko I, O'Day S, M DJ, Garbe C, et al. Ipilimumab plus dacarbazine for previously untreated metastatic melanoma. N Engl J Med 2011;364:2517-26.
30. Robert C, Long GV, Brady B, Dutriaux C, Maio M, Mortier L, et al. Nivolumab in previously untreated melanoma without BRAF mutation. N Engl J Med 2015;372:320-30.
31. Kefford R, Ribas A, Hamid O, Robert C, Daud A, Wolchok JD, et al. Clinical efficacy and correlation with tumor PD-L1 expression in patients with melanoma treated with the anti-PD-1 monoclonal antibody pembrolizumab (MK-3475). J Clin Oncol 32:5s, 2014 (suppl; abstr 3005).
32. Herbst RS, Soria JC, Kowanetz M, Fine GD, Hamid O, Gordon MS, et al. Predictive correlates of response to the anti-PD-L1 antibody MPDL3280A in cancer patients. Nature 2014;515:563-7.