Safety and activity of anti-PD-L1 antibody in patients with advanced cancer

New England Journal of Medicine

Volumn 366, Issue 26, 2012, Pages 2455-2465

  Brahmer, Julie R ^a   Tykodi, Scott S ^a,b   Chow, Laura Q M ^b   Hwu, Wen Jen ^c   Topalian, Suzanne L ^a   Hwu, Patrick ^c   Drake, Charles G ^a   Camacho, Luis H ^d   Kauh, John ^e   Odunsi, Kunle ^f   Pitot, Henry C ^g   Hamid, Omid ^h   Bhatia, Shailender ^b   Martins, Renato ^b   Eaton, Keith ^b   Chen, Shuming ^a   Salay, Theresa M ^a   Alaparthy, Suresh ^j   Grosso, Joseph F ^j   Korman, Alan J ⁱ   Parker, Susan M ^j   Agrawal, Shruti ^j   Goldberg, Stacie M ^j   Pardoll, Drew M ^a   Gupta, Ashok ^j   Wigginton, Jon M ^j   more..

^a JOHNS HOPKINS UNIVERSITY SCHOOL OF MEDICINE   (United States)

^b UNIVERSITY OF WASHINGTON   (United States)

^c UNIVERSITY OF TEXAS MD ANDERSON CANCER CENTER   (United States)

^d St Luke's Episcopal Hospital   (United States)

^e EMORY UNIVERSITY   (United States)

^f ROSWELL PARK CANCER INSTITUTE   (United States)

^g Mayo Clinic   (United States)

^h Angeles Clinic   (United States)

ⁱ Research and Development Oncology   (United States)

^j BRISTOL MYERS SQUIBB   (United States)

more..

Author keywords

[No Author keywords available]

Indexed keywords

ANTINEOPLASTIC AGENT; BMS 936559; UNCLASSIFIED DRUG;

ADRENAL INSUFFICIENCY; ADVANCED CANCER; AREA UNDER THE CURVE; ARTHRALGIA; ARTICLE; AUTOIMMUNE THYROIDITIS; BREAST CANCER; COLORECTAL CANCER; DIABETES MELLITUS; DIARRHEA; DISEASE SEVERITY; DOSE RESPONSE; DRUG ACTIVITY; DRUG DOSE ESCALATION; DRUG EFFICACY; DRUG ERUPTION; DRUG HALF LIFE; DRUG HYPERSENSITIVITY; DRUG SAFETY; DRUG WITHDRAWAL; DRY EYE; ENDOPHTHALMITIS; ERYTHEMA; FATIGUE; HEADACHE; HEPATITIS; HUMAN; HUMAN CELL; HYPOTHYROIDISM; INFUSION RELATED REACTION; KIDNEY CARCINOMA; LUNG NON SMALL CELL CANCER; MAJOR CLINICAL STUDY; MAXIMUM PLASMA CONCENTRATION; MELANOMA; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; MYASTHENIA GRAVIS; NAUSEA; OVARY CANCER; PANCREAS CANCER; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; PRURITUS; SARCOIDOSIS; SIDE EFFECT; STOMACH CANCER; TREATMENT DURATION; TREATMENT OUTCOME; VITILIGO;

EID: 84862903106     PISSN: 00284793     EISSN: 15334406     Source Type: Journal    
DOI: 10.1056/NEJMoa1200694     Document Type: Article

References (39)

1. Weiner LM, Surana R, Wang S. Monoclonal antibodies: versatile platforms for cancer immunotherapy. Nat Rev Immunol 2010;10:317-27.
2. Topalian SL, Weiner GJ, Pardoll DM. Cancer immunotherapy comes of age. J Clin Oncol 2011;29:4828-36.
3. Mellman I, Coukos G, Dranoff G. Cancer immunotherapy comes of age. Nature 2011;480:480-9.
4. Pardoll DM. Blockade of immune checkpoints in cancer immunotherapy. Nat Rev Cancer 2012;12:252-64.
5. Linsley PS, Brady W, Urnes M, Grosmaire LS, Damle NK, Ledbetter JA. CTLA-4 is a second receptor for the B cell activation antigen B7. J Exp Med 1991;174:561-9.
6. 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 U S A 2003;100:8372-7. (Pubitemid 36842552)
7. Tivol EA, Borriello F, Schweitzer AN, Lynch WP, Bluestone JA, Sharpe AH. Loss of CTLA-4 leads to massive lymphoproliferation and fatal multiorgan tissue destruction, revealing a critical negative regulatory role of CTLA-4. Immunity 1995;3: 541-7.
8. Leach DR, Krummel MF, Allison JP. Enhancement of antitumor immunity by CTLA-4 blockade. Science 1996;271:1734-6. (Pubitemid 26102823)
9. 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. [Erratum, N Engl J Med 2010;363:1290.]
10. Nishimura H, Nose M, Hiai H, Minato N, Honjo T. Development of lupus-like autoimmune diseases by disruption of the PD-1 gene encoding an ITIM motif-carrying immunoreceptor. Immunity 1999;11: 141-51. (Pubitemid 29428807)
11. Okazaki T, Honjo T. PD-1 and PD-1 ligands: from discovery to clinical application. Int Immunol 2007;19:813-24. (Pubitemid 47241890)
12. Dong H, Zhu G, Tamada K, Chen L. B7-H1, a third member of the B7 family, co-stimulates T-cell proliferation and interleukin-10 secretion. Nat Med 1999;5: 1365-9.
13. Freeman GJ, Long AJ, Iwai Y, et al. Engagement of the PD-1 immunoinhibitory receptor by a novel B7 family member leads to negative regulation of lymphocyte activation. J Exp Med 2000;192:1027-34.
14. Tseng SY, Otsuji M, Gorski K, et al. B7-DC, a new dendritic cell molecule with potent costimulatory properties for T cells. J Exp Med 2001;193:839-46.
15. Latchman Y, Wood CR, Chernova T, et al. PD-L2 is a second ligand for PD-1 and inhibits T cell activation. Nat Immunol 2001;2:261-8. (Pubitemid 33706004)
16. Dong H, Strome SE, Salomao DR, et al. Tumor-associated B7-H1 promotes T-cell apoptosis: a potential mechanism of immune evasion. Nat Med 2002;8:793-800. [Erratum, Nat Med 2002;8:1039.]
17. Iwai Y, Ishida M, Tanaka Y, Okazaki T, Honjo T, Minato N. Involvement of PD-L1 on tumor cells in the escape from host immune system and tumor immunotherapy by PD-L1 blockade. Proc Natl Acad Sci U S A 2002;99:12293-7.
18. Zou W, Chen L. Inhibitory B7-family molecules in the tumour microenvironment. Nat Rev Immunol 2008;8:467-77. (Pubitemid 351733418)
19. Curiel TJ, Wei S, Dong H, et al. Blockade of B7-H1 improves myeloid dendritic cell-mediated antitumor immunity. Nat Med 2003;9:562-7. (Pubitemid 36597102)
20. Fife BT, Pauken KE, Eagar TN, et al. Interactions between PD-1 and PD-L1 promote tolerance by blocking the TCRinduced stop signal. Nat Immunol 2009;10:1185-92.
21. Hino R, Kabashima K, Kato Y, et al. Tumor cell expression of programmed cell death-1 ligand 1 is a prognostic factor for malignant melanoma. Cancer 2010; 116:1757-66.
22. Taube JM, Anders RA, Young JD, 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.
23. 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)
24. Therasse P, Arbuck SG, Eisenhauer EA, et al. New guidelines to evaluate the response to treatment in solid tumors: European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada. J Natl Cancer Inst 2000;92:205-16.
25. Cancer Therapy Evaluation Program (CTEP) Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0. Bethesda, MD: National Cancer Institute, April 2003 (http://ctep.cancer.gov/protocol Development/electronic-applications/ docs/ctcaev3.pdf).
26. 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.
27. 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.
28. Dong H, Zhu G, Tamada K, Flies DB, van Deursen JM, Chen L. B7-H1 determines accumulation and deletion of intrahepatic CD8(+) T lymphocytes. Immunity 2004;20:327-36. (Pubitemid 38388234)
29. Ribas A, Camacho LH, Lopez-Berestein G, et al. Antitumor activity in melanoma and anti-self responses in a phase I trial with the anti-cytotoxic T lymphocyte-associated antigen 4 monoclonal antibody CP-675,206. J Clin Oncol 2005; 23:8968-77. (Pubitemid 46217464)
30. Beck KE, Blansfield JA, Tran KQ, et al. Enterocolitis in patients with cancer after antibody blockade of cytotoxic T-lymphocyte-associated antigen 4. J Clin Oncol 2006;24:2283-9. (Pubitemid 46630658)
31. Holt GE, Podack ER, Raez LE. Immunotherapy as a strategy for the treatment of non-small-cell lung cancer. Therapy 2011;8:43-54.
32. Gajewski TF, Louahed J, Brichard VG. Gene signature in melanoma associated with clinical activity: a potential clue to unlock cancer immunotherapy. Cancer J 2010;16:399-403.
33. Sharma P, Wagner K, Wolchok JD, Allison JP. Novel cancer immunotherapy agents with survival benefit: recent successes and next steps. Nat Rev Cancer 2011;11:805-12.
34. 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.
35. Park JJ, Omiya R, Matsumura Y, et al. B7-H1/CD80 interaction is required for the induction and maintenance of peripheral T-cell tolerance. Blood 2010;116:1291-8.
36. Paterson AM, Brown KE, Keir ME, et al. The programmed death-1 ligand 1:B7-1 pathway restrains diabetogenic effector T cells in vivo. J Immunol 2011;187:1097-105.
37. Yang J, Riella LV, Chock S, et al. The novel costimulatory programmed death ligand 1/B7.1 pathway is functional in inhibiting alloimmune responses in vivo. J Immunol 2011;187:1113-9.
38. Butte MJ, Keir ME, Phamduy TB, Sharpe AH, Freeman GJ. Programmed death-1 ligand 1 interacts specifically with the B7-1 costimulatory molecule to inhibit T cell responses. Immunity 2007;27:111-22. (Pubitemid 47089023)
39. Butte MJ, Peña-Cruz V, Kim MJ, Freeman GJ, Sharpe AH. Interaction of human PD-L1 and B7-1. Mol Immunol 2008;45: 3567-72.