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Cited by 1,001Cancer Immunotherapy and BiomarkersLymphoma Diagnosis and TreatmentT-cell and B-cell Immunology

Nivolumab in Patients With Relapsed or Refractory Hematologic Malignancy: Preliminary Results of a Phase Ib Study

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Lesokhin, Alexander M., Ansell, Stephen M., Armand, Philippe, Scott, Emma C., Halwani, Ahmad, Gutierrez, Martin, Millenson, Michael M., Cohen, Adam D. +15 more·2016·Journal of Clinical Oncology
DOI 10.1200/jco.2015.65.9789PMC PMC5019749
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Abstract

Purpose: Cancer cells can exploit the programmed death-1 (PD-1) immune checkpoint pathway to avoid immune surveillance by modulating T-lymphocyte activity. In part, this may occur through overexpression of PD-1 and PD-1 pathway ligands (PD-L1 and PD-L2) in the tumor microenvironment. PD-1 blockade has produced significant antitumor activity in solid tumors, and similar evidence has emerged in hematologic malignancies. Methods: In this phase I, open-label, dose-escalation, cohort-expansion study, patients with relapsed or refractory B-cell lymphoma, T-cell lymphoma, and multiple myeloma received the anti–PD-1 monoclonal antibody nivolumab at doses of 1 or 3 mg/kg every 2 weeks. This study aimed to evaluate the safety and efficacy of nivolumab and to assess PD-L1/PD-L2 locus integrity and protein expression. Results: Eighty-one patients were treated (follicular lymphoma, n = 10; diffuse large B-cell lymphoma, n = 11; other B-cell lymphomas, n = 10; mycosis fungoides, n = 13; peripheral T-cell lymphoma, n = 5; other T-cell lymphomas, n = 5; multiple myeloma, n = 27). Patients had received a median of three (range, one to 12) prior systemic treatments. Drug-related adverse events occurred in 51 (63%) patients, and most were grade 1 or 2. Objective response rates were 40%, 36%, 15%, and 40% among patients with follicular lymphoma, diffuse large B-cell lymphoma, mycosis fungoides, and peripheral T-cell lymphoma, respectively. Median time of follow-up observation was 66.6 weeks (range, 1.6 to 132.0+ weeks). Durations of response in individual patients ranged from 6.0 to 81.6+ weeks. Conclusion: Nivolumab was well tolerated and exhibited antitumor activity in extensively pretreated patients with relapsed or refractory B- and T-cell lymphomas. Additional studies of nivolumab in these diseases are ongoing.

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Crossref · 10.1200/jco.2015.65.9789

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  • In a study by Lesokhin and colleagues, Nivolumab did not show any tumor response in relapsed/refractory MM.

    “In this study, they investigated the effect of Nivolumab but did not show any tumor response in relapsed/refractory MM [207].”

    From Mesenchymal stromal cells in bone marrow niche of patients with multiple myeloma: a double-edged sword (2025) · cites this paper as [207]

  • Nivolumab and pembrolizumab as single agents showed limited efficacy in relapsed/refractory multiple myeloma patients.

    “A phase 1b clinical data demonstrated limited efficacy of nivolumab and pembrolizumab as single agents in RRMM patients [177].”

    From Multiple myeloma: signaling pathways and targeted therapy (2024) · cites this paper as [177]

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Authors
Lesokhin, A. M., Ansell, S. M., Armand, P., Scott, E. C., Halwani, A., Gutierrez, M., Millenson, M. M., Cohen, A. D., Schuster, S. J., Lebovic, D., Dhodapkar, M., Avigan, D., Chapuy, B., Ligon, A. H., Freeman, G. J., Rodig, S. J., Cattry, D., Zhu, L., Grosso, J. F., Bradley Garelik, M. B., Shipp, M. A., Borrello, I., & Timmerman, J.
Affiliations
  • Brigham and Women's Hospital (US)
  • Alexander M. Lesokhin and Deepika Cattry, Memorial Sloan Kettering Cancer Center; Alexander M. Lesokhin, Weill Cornell Medical College, New York, NY; Stephen M. Ansell, Mayo Clinic, Rochester, MN; Philippe Armand, Bjoern Chapuy, Gordon J. Freeman, Scott J. Rodig, and Margaret A. Shipp, Dana-Farber Cancer Institute; David Avigan, Beth Israel Deaconess Medical Center; Azra H. Ligon and Scott J. Rodig, Brigham and Women’s Hospital, Boston, MA; Emma C. Scott, Oregon Health & Science University Knight Cancer...
ORCID
Venue
Journal of Clinical Oncology
Publisher
American Society of Clinical Oncology (ASCO)
Published
2016-08-10
Volume
34
Issue
23
Pages
2698-2704
ISSN
  • 0732-183X (ISSN-L)
  • 1527-7755
DOI
10.1200/jco.2015.65.9789
PMC
PMC5019749
OpenAlex
W2412725897
Cited by
1,001
References
3
Citations by year
2026: 23 · 2025: 42 · 2024: 58 · 2023: 83 · 2022: 91 · 2021: 134 · 2020: 141 · 2019: 132 · 2018: 138 · 2017: 118 · 2016: 37 · 2015: 2
FWCI
76.41
Type
journal article
Language
en
Open access
Locations
  • Journal of Clinical Oncology (publishedVersion)
  • PubMed Central (publishedVersion)
  • PubMed (publishedVersion)
Funders
  • Amgen
  • Bristol-Myers Squibb
  • Eli Lilly and Company
  • AstraZeneca
  • Bayer
  • GlaxoSmithKline
  • Sanofi
  • Gilead Sciences
  • Celgene
  • Karyopharm Therapeutics
  • Exelixis
  • Celldex Therapeutics
  • TG Therapeutics
  • Acceleron
  • Incyte
  • Kyowa Hakko Kirin
  • National Institutes of Health (UL1TR001863)
  • Genentech
  • EMD Serono
  • Onyx Pharmaceuticals
  • Takeda Oncology
  • Pharmacyclics
  • Foundation Medicine
  • National Cancer Institute (U54CA163125, R01CA161026, P30CA006927, P30CA008748)
  • National Institute of Allergy and Infectious Diseases (P01AI056299)
  • National Center for Advancing Translational Sciences
  • Janssen Pharmaceuticals
  • Daiichi Sankyo Europe
Topics
  • Health Sciences › Medicine › Oncology › Cancer Immunotherapy and Biomarkers
  • Health Sciences › Medicine › Pathology and Forensic Medicine › Lymphoma Diagnosis and Treatment
  • Life Sciences › Immunology and Microbiology › Immunology › T-cell and B-cell Immunology
Keywords
nivolumab, anti-PD-1 therapy, immune checkpoint inhibitors, relapsed or refractory hematologic malignancies, B-cell lymphoma, T-cell lymphoma, multiple myeloma, follicular lymphoma, diffuse large B-cell lymphoma, mycosis fungoides, PD-L1, PD-L2, tumor microenvironment, drug safety, anticancer activity
MeSH terms
Nivolumab, Adult, Aged, Aged, 80 and over, Antibodies, Monoclonal, Antineoplastic Agents, Chromosome Aberrations, Chromosomes, Human, Pair 9, Female, Humans, Lymphocyte Activation, Male, Middle Aged, Multiple Myeloma, Mycosis Fungoides, Pneumonia, T-Lymphocytes, Biomarkers, Tumor, Lymphoma, B-Cell, Lymphoma, T-Cell, Treatment Outcome, Retreatment, Cell Proliferation, Young Adult, B7-H1 Antigen, Programmed Cell Death 1 Ligand 2 Protein

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