Nivolumab in patients with relapsed or refractory hematologic malignancy: Preliminary results of a phase ib study

Journal of Clinical Oncology

Volumn 34, Issue 23, 2016, Pages 2698-2704

  Lesokhin, Alexander M ^a   Ansell, Stephen M ^b   Armand, Philippe ^c   Scott, Emma C ^f   Halwani, Ahmad ^g   Gutierrez, Martin ^h   Millenson, Michael M ^j   Cohen, Adam D ^k   Schuster, Stephen J ^k   Lebovic, Daniel ^l   Dhodapkar, Madhav ^m   Avigan, David ^d   Chapuy, Bjoern ^c   Ligon, Azra H ^e   Freeman, Gordon J ^c   Rodig, Scott J ^c,e   Cattry, Deepika ^a   Zhu, Lili ⁱ   Grosso, Joseph F ⁱ   Brigid Bradley Garelik, M ⁱ   Shipp, Margaret A ^c   Borrello, Ivan ^a   Timmerman, John ⁿ   more..

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

^b MAYO CLINIC   (United States)

^c DANA FARBER CANCER INSTITUTE   (United States)

^d BETH ISRAEL DEACONESS MEDICAL CENTER   (United States)

^e BRIGHAM AND WOMEN S HOSPITAL   (United States)

^f OREGON HEALTH AND SCIENCE UNIVERSITY   (United States)

^g UNIVERSITY OF UTAH   (United States)

^h HACKENSACK UNIVERSITY MEDICAL CENTER   (United States)

ⁱ BRISTOL MYERS SQUIBB   (United States)

^j FOX CHASE CANCER CENTER   (United States)

^k UNIVERSITY OF PENNSYLVANIA   (United States)

^l UNIVERSITY OF MICHIGAN   (United States)

^m YALE CANCER CENTER   (United States)

ⁿ UNIVERSITY OF CALIFORNIA   (United States)

more..

Author keywords

[No Author keywords available]

Indexed keywords

CREATINE KINASE; CREATININE; NIVOLUMAB; PROGRAMMED DEATH 1 LIGAND 1; PROGRAMMED DEATH 1 LIGAND 2; TRIACYLGLYCEROL LIPASE; ANTINEOPLASTIC AGENT; CD274 PROTEIN, HUMAN; MONOCLONAL ANTIBODY; PDCD1LG2 PROTEIN, HUMAN; TUMOR MARKER;

ADULT; ADULT RESPIRATORY DISTRESS SYNDROME; AGED; ANEMIA; ANTINEOPLASTIC ACTIVITY; ARTICLE; B CELL LYMPHOMA; CHRONIC MYELOID LEUKEMIA; COHORT ANALYSIS; CREATINE KINASE BLOOD LEVEL; CREATININE BLOOD LEVEL; DECREASED APPETITE; DIARRHEA; DIPLOPIA; DRUG DOSE ESCALATION; DRUG SAFETY; DRUG TOLERABILITY; ENTERITIS; EOSINOPHILIA; FATIGUE; FEMALE; FEVER; FOLLICULAR LYMPHOMA; FOLLOW UP; GENE LOCUS; GENE OVEREXPRESSION; HEMATOLOGIC MALIGNANCY; HUMAN; HYPERSENSITIVITY; HYPOCALCEMIA; LARGE CELL LYMPHOMA; LEUKOPENIA; LUNG EMBOLISM; LYMPHOCYTE COUNT; LYMPHOCYTOPENIA; MAJOR CLINICAL STUDY; MALE; MUCOSA INFLAMMATION; MULTIPLE MYELOMA; MYCOSIS FUNGOIDES; NEUTROPENIA; OPEN STUDY; PERIPHERAL T CELL LYMPHOMA; PHASE 1 CLINICAL TRIAL; PNEUMONIA; PRIORITY JOURNAL; PROTEIN EXPRESSION; PRURITUS; RASH; SEPSIS; STOMATITIS; SYSTEMIC THERAPY; T CELL LYMPHOMA; TREATMENT RESPONSE; TRIACYLGLYCEROL LIPASE BLOOD LEVEL; TUMOR MICROENVIRONMENT; CELL PROLIFERATION; CHEMICALLY INDUCED; CHROMOSOME 9; CHROMOSOME ABERRATION; CLINICAL TRIAL; DRUG EFFECTS; GENETICS; LYMPHOCYTE ACTIVATION; LYMPHOMA, B-CELL; LYMPHOMA, T-CELL; METABOLISM; MIDDLE AGED; PATHOLOGY; PHYSIOLOGY; RETREATMENT; T LYMPHOCYTE; TREATMENT OUTCOME; VERY ELDERLY; YOUNG ADULT;

ADULT; AGED; AGED, 80 AND OVER; ANTIBODIES, MONOCLONAL; ANTIGENS, CD274; ANTINEOPLASTIC AGENTS; BIOMARKERS, TUMOR; CELL PROLIFERATION; CHROMOSOME ABERRATIONS; CHROMOSOMES, HUMAN, PAIR 9; FEMALE; HUMANS; LYMPHOCYTE ACTIVATION; LYMPHOMA, B-CELL; LYMPHOMA, T-CELL; MALE; MIDDLE AGED; MULTIPLE MYELOMA; MYCOSIS FUNGOIDES; PNEUMONIA; PROGRAMMED CELL DEATH 1 LIGAND 2 PROTEIN; RETREATMENT; T-LYMPHOCYTES; TREATMENT OUTCOME; YOUNG ADULT;

EID: 84979240618     PISSN: 0732183X     EISSN: 15277755     Source Type: Journal    
DOI: 10.1200/JCO.2015.65.9789     Document Type: Article

References (25)

1. Chen BJ, Chapuy B, Ouyang J, et al: PD-L1 expression is characteristic of a subset of aggressive B-cell lymphomas and virus-Associated malignancies. Clin Cancer Res 19:3462-3473, 2013
2. Andorsky DJ, Yamada RE, Said J, et al: Programmed death ligand 1 is expressed by non-Hodgkin lymphomas and inhibits the activity of tumor-Associated T cells. Clin Cancer Res 17:4232-4244, 2011
3. Wilcox RA, Feldman AL, Wada DA, et al: B7-H1 (PD-L1, CD274) suppresses host immunity in T-cell lymphoproliferative disorders. Blood 114:2149-2158, 2009
4. Yang ZZ, Grote DM, Ziesmer SC, et al: PD-1 expression defines two distinct T-cell sub-populations in follicular lymphoma that differentially impact patient survival. Blood Cancer J 5:e281, 2015
5. Green MR, Monti S, Rodig SJ, et al: Integrative analysis reveals selective 9p24.1 amplification, increased PD-1 ligand expression, and further induction via JAK2 in nodular sclerosing Hodgkin lymphoma and primary mediastinal large B-cell lymphoma. Blood 116:3268-3277, 2010
6. Twa DD, Chan FC, Ben-Neriah S, et al: Genomic rearrangements involving programmed death ligands are recurrent in primary mediastinal large B-cell lymphoma. Blood 123:2062-2065, 2014
7. Shi M, Roemer MG, Chapuy B, et al: Expression of programmed cell death 1 ligand 2 (PD-L2) is a distinguishing feature of primarymediastinal (thymic) large B-cell lymphoma and associated with PDCD1LG2 copy gain. Am J Surg Pathol 38:1715-1723, 2014
8. Ansell SM, Lesokhin AM, Borrello I, et al: PD-1 blockade with nivolumab in relapsed or refractory Hodgkin's lymphoma. N Engl J Med 372:311-319, 2015
9. Liu J, Hamrouni A, Wolowiec D, et al: Plasma cells from multiple myeloma patients express B7-H1 (PD-L1) and increase expression after stimulation with IFN-gamma and TLR ligands via a MyD88-, TRAF6-, and MEK-dependent pathway. Blood 110: 296-304, 2007
10. Pardoll DM: The blockade of immune checkpoints in cancer immunotherapy. Nat Rev Cancer 12: 252-264, 2012
11. Reiss KA, Forde PM, Brahmer JR: Harnessing the power of the immune system via blockade of PD-1 and PD-L1: A promising new anticancer strategy. Immunotherapy 6:459-475, 2014
12. Topalian SL, Hodi FS, Brahmer JR, et al: Safety, activity, and immune correlates of anti-PD-1 antibody in cancer. N Engl J Med 366:2443-2454, 2012
13. 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 366:2455-2465, 2012
14. Wolchok JD, Kluger H, Callahan MK, et al: Nivolumab plus ipilimumab in advanced melanoma. N Engl J Med 369:122-133, 2013
15. Robert C, Ribas A, Wolchok JD, 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 384:1109-1117, 2014
16. International Conference on Harmonisation Expert Working Group: Guidance for Industry: E6 Good Clinical Practice: Consolidated Guidance.Rockville, MD, Center for Drug Evaluation and Research, 1996
17. World Medical Association Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects. 59th WMA General Assembly, Seoul, Korea, October 2008
18. National Cancer Institute: Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0; US Department of Health and Human Services. Bethesda, MD, National Institutes of Health, 2009
19. Mahoney KM, Sun H, Liao X, et al: PD-L1 antibodies to its cytoplasmic domain most clearly delineate cell membranes in immunohistochemical staining of tumor cells. Cancer Immunol Res 3: 1308-1315, 2015
20. Cheson BD, Pfistner B, Juweid ME, et al: Revised response criteria for malignant lymphoma. J Clin Oncol 25:579-586, 2007
21. Rajkumar SV, Harousseau JL, Durie B, et al: Consensus recommendations for the uniform reporting of clinical trials: Report of the International Myeloma Workshop Consensus Panel 1. Blood 117:4691-4695, 2011
22. Olsen EA, Whittaker S, Kim YH, et al: Clinical end points and response criteria in mycosis fungoides and Sé zary syndrome: A consensus statement of the International Society for Cutaneous Lymphomas, the United States Cutaneous Lymphoma Consortium, and the Cutaneous Lymphoma Task Force of the European Organisation for Research and Treatment of Cancer. J Clin Oncol 29: 2598-2607, 2011
23. Postow MA, Callahan MK, Barker CA, et al: Immunologic correlates of the abscopal effect in a patient with melanoma. N Engl J Med 366: 925-931, 2012
24. Kawano Y, Moschetta M, Manier S, et al: Targeting the bone marrow microenvironment in multiple myeloma. Immunol Rev 263:160-172, 2015
25. Ansell SM, Hurvitz SA, Koenig PA, et al: Phase I study of ipilimumab, an anti-CTLA-4 monoclonal antibody, in patients with relapsed and refractory B-cell non-Hodgkin lymphoma. Clin Cancer Res 15: 6446-6453, 2009