Nivolumab plus Ipilimumab in advanced melanoma

New England Journal of Medicine

Volumn 369, Issue 2, 2013, Pages 122-133

  Wolchok, Jedd D ^a   Kluger, Harriet ^b   Callahan, Margaret K ^a   Postow, Michael A ^a   Rizvi, Naiyer A ^a   Lesokhin, Alexander M ^a   Segal, Neil H ^a   Ariyan, Charlotte E ^a   Gordon, Ruth Ann ^a   Reed, Kathleen ^b   Burke, Matthew M ^b   Caldwell, Anne ^b   Kronenberg, Stephanie A ^a   Agunwamba, Blessing U ^a   Zhang, Xiaoling ^c   Lowy, Israel ^e   Inzunza, Hector David ^e   Feely, William ^e   Horak, Christine E ^e   Hong, Quan ^e   Korman, Alan J ^d   Wigginton, Jon M ^e   Gupta, Ashok ^e   Sznol, Mario ^b   more..

^a MEMORIAL SLOAN KETTERING CANCER CENTER   (United States)

^b YALE UNIVERSITY SCHOOL OF MEDICINE   (United States)

^c AGILENT TECHNOLOGIES   (United States)

^d Biologics Discovery California   (United States)

^e BRISTOL MYERS SQUIBB   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

GLUCOCORTICOID; IMMUNOSUPPRESSIVE AGENT; INFLIXIMAB; IPILIMUMAB; LACTATE DEHYDROGENASE; MYCOPHENOLIC ACID 2 MORPHOLINOETHYL ESTER; NIVOLUMAB; PROGRAMMED DEATH 1 RECEPTOR;

ACUTE KIDNEY FAILURE; ADRENAL INSUFFICIENCY; ADULT; ADVANCED CANCER; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; BLISTER; CANCER GROWTH; CANCER REGRESSION; COLITIS; CONTROLLED STUDY; CREATININE BLOOD LEVEL; DIARRHEA; DRUG DOSE ESCALATION; DRUG EFFICACY; DRUG ERUPTION; DRUG FATALITY; DRUG MEGADOSE; DRUG SAFETY; DRUG WITHDRAWAL; ENDOCRINE DISEASE; FATIGUE; FEMALE; HORMONE SUBSTITUTION; HUMAN; HYPERTHYROIDISM; HYPOPHYSITIS; HYPOTHYROIDISM; INFUSION RELATED REACTION; INTERSTITIAL NEPHRITIS; KIDNEY DISEASE; KIDNEY FAILURE; LACTATE DEHYDROGENASE BLOOD LEVEL; LYMPHOCYTE COUNT; MAJOR CLINICAL STUDY; MALE; MELANOMA; MONOTHERAPY; PHASE 1 CLINICAL TRIAL; PNEUMONIA; PRIORITY JOURNAL; PROTEIN EXPRESSION; PRURITUS; SIDE EFFECT; THYROID FUNCTION TEST; THYROIDITIS; TREATMENT RESPONSE; TRIACYLGLYCEROL LIPASE BLOOD LEVEL; URTICARIA; UVEITIS;

EID: 84879777241     PISSN: 00284793     EISSN: 15334406     Source Type: Journal    
DOI: 10.1056/NEJMoa1302369     Document Type: Article

References (27)

1. Schreiber RD, Old LJ, Smyth MJ. Cancer immunoediting: integrating immunity's roles in cancer suppression and promotion. Science 2011;331:1565-70.
2. Hanahan D, Weinberg RA. Hallmarks of cancer: the next generation. Cell 2011;144:646-74.
3. Hodi FS, O'Day SJ, McDermott DF, et al. Improved survival with ipilimumab in patients with metastatic melanoma. N Engl J Med 2010;363:711-23.
4. Robert C, Thomas L, Bondarenko I, et al. Ipilimumab plus dacarbazine for previously untreated metastatic melanoma. N Engl J Med 2011;364:2517-26.
5. Topalian SL, Hodi FS, Brahmer JR, et al. Safety, activity, and immune correlates of anti-PD-1 antibody in cancer. N Engl J Med 2012;366:2443-54.
6. 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 melanoma tumors. Proc Natl Acad Sci U S A 2010;107:4275-80.
7. Selby M, Engelhardt J, Lu L-S, et al. Antitumor activity of concurrent blockade of immune checkpoint molecules CTLA-4 and PD-1 in preclinical models. J Clin Oncol 2013;31:Suppl. abstract.
8. Oken MM, Creech RH, Tormey DC, et al. Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J Clin Oncol 1982;5:649-55. (Pubitemid 13149996)
9. 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 2009;15:7412-20.
10. Cancer Therapy Evaluation Program (CTEP) Common Terminology Criteria for Adverse Event v3.0 (CTCAE). Washington, DC: Division of Cancer Treatment and Diagnosis, National Cancer Institute, National Institutes of Health, Department of Health and Human Services, August 9, 2006 (http://ctep.cancer.gov/ protocolDevelopment/electronic-applications/docs/ctcaev3.pdf).
11. Taube JM, Anders RA, Young GD, et al. Colocalization of inflammatory response with B7-h1 expression in human melanocytic lesions supports an adaptive resistance mechanism of immune escape. Sci Transl Med 2012;4:127ra37.
12. Yervoy. Princeton, NJ: Bristol-Myers Squibb, 2012 (package insert).
13. Berman DM, Wolchok J, Weber J, et al. Association of peripheral blood absolute lymphocyte count (ALC) and clinical activity in patients (pts) with advanced melanoma treated with ipilimumab. J Clin Oncol 2009;27:Suppl:15s. abstract.
14. Ku GY, Yuan J, Page DB, et al. Single-institution experience with ipilimumab in advanced melanoma patients in the compassionate use setting: lymphocyte count after 2 doses correlates with survival. Cancer 2010;116:1767-75.
15. Postow MA, Yuan J, Panageas K, et al. Evaluation of the absolute lymphocyte count as a biomarker for melanoma patients treated with the commercially available dose of ipilimumab (3mg/kg). J Clin Oncol 2012;30:Suppl. abstract.
16. Delyon J, Mateus C, Lefeuvre D, et al. Experience in daily practice with ipilimumab for the treatment of patients with metastatic melanoma: an early increase in lymphocyte and eosinophil counts is associated with improved survival. Ann Oncol 2013 February 24 (Epub ahead of print).
17. O'Day SJ, Hamid O, Urba WJ. Targeting cytotoxic T-lymphocyte antigen-4 (CTLA-4): a novel strategy for the treatment of melanoma and other malignancies. Cancer 2007;110:2614-27. (Pubitemid 350250330)
18. Fong L, Small EJ. Anti-cytotoxic T-lymphocyte antigen-4 antibody: the first in an emerging class of immunomodulatory antibodies for cancer treatment. J Clin Oncol 2008;26:5275-83.
19. Robert C, Ghiringhelli F. What is the role of cytotoxic T lymphocyte-associated antigen 4 blockade in patients with metastatic melanoma? Oncologist 2009;14:848-61.
20. Brahmer JR, Drake CG, Wollner I, 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.
21. Lipson EJ, Sharfman WH, Drake CG, et al. Durable cancer regression off-treatment and effective reinduction therapy with an anti-PD-1 antibody. Clin Cancer Res 2013;19:462-8.
22. Brahmer JR, Tykodi SS, Chow LQ, et al. Safety and activity of anti-PD-L1 antibody in patients with advanced cancer. N Engl J Med 2012;366:2455-65.
23. Parry RV, Chemnitz JM, Frauwirth KA, et al. CTLA-4 and PD-1 receptors inhibit T-cell activation by distinct mechanisms. Mol Cell Biol 2005;25:9543-53. (Pubitemid 41507854)
24. Chapman PB, Hauschild A, Robert C, et al. Improved survival with vemurafenib in melanoma with BRAF V600E mutation. N Engl J Med 2011;364:2507-16.
25. Sznol M, Kluger HM, Hodi S, et al. Survival and long-term follow-up of safety and response in patients (pts) with advanced melanoma (MEL) in a phase 1 trial of nivolumab (anti-PD-1; BMS-936558; ONO-4538). J Clin Oncol 2013;31:Suppl. abstract.
26. Wolchok JD, Weber JS, Maio M, et al. Four-year survival rates for patients with metastatic melanoma who received ipilimumab in phase II clinical trials. Ann Oncol 2013 May 10 (Epub ahead of print).
27. Gordon MS, Hamid O, Powderly J, et al. A phase I study of MPDL3280A, an engineered PD-L1 antibody in patients with locally advanced or metastatic tumors. Presented at the Annual Meeting of the American Association of Cancer Research, Washington, DC, April 6-10, 2013. abstract.