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Safety, Activity, and Immune Correlates of Anti–PD-1 Antibody in Cancer

New England Journal of Medicine · 2012 · Vol. 366(26) · pp. 2443–2454

Suzanne L. Topalian✉(Sidney Kimmel Comprehensive Cancer Center)F. Stephen Hodi(Dana-Farber Cancer Institute)Julie R. Brahmer(Sidney Kimmel Comprehensive Cancer Center)Scott Gettinger(Yale Cancer Center)David C. Smith(University of Michigan–Ann Arbor)David F. McDermott(Hadassah Medical Center)John D. Powderly(Carolina BioOncology Institute)Richard D. Carvajal(Memorial Sloan Kettering Cancer Center)Jeffrey A. Sosman(Vanderbilt University Medical Center)Michael B. Atkins(Hadassah Medical Center)Philip D. Leming(Oncology Hematology Care)David R. Spigel(Sarah Cannon)Scott Antonia(Moffitt Cancer Center)Leora Horn(Vanderbilt University Medical Center)Charles G. Drake(Johns Hopkins University)Drew M. Pardoll(Sidney Kimmel Comprehensive Cancer Center)Lieping Chen(Yale Cancer Center)William H. Sharfman(Johns Hopkins University)Robert A. Anders(Johns Hopkins University)Janis M. Taube(Johns Hopkins University)Tracee L. McMiller(Johns Hopkins University)Haiying Xu(Sidney Kimmel Comprehensive Cancer Center)Alan J. Korman(Bristol-Myers Squibb (United States))Maria Jure–Kunkel(Bristol-Myers Squibb (United States))Shruti Agrawal(Bristol-Myers Squibb (United States))D. G. McDonald(Bristol-Myers Squibb (United States))Georgia Kollia(Bristol-Myers Squibb (United States))Ashok Gupta(Bristol-Myers Squibb (United States))Jon M. Wigginton(Bristol-Myers Squibb (United States))Mario Sznol(Yale Cancer Center)

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Abstract

Anti-PD-1 antibody produced objective responses in approximately one in four to one in five patients with non-small-cell lung cancer, melanoma, or renal-cell cancer; the adverse-event profile does not appear to preclude its use. Preliminary data suggest a relationship between PD-L1 expression on tumor cells and objective response. (Funded by Bristol-Myers Squibb and others; ClinicalTrials.gov number, NCT00730639.).

Cancer Immunotherapy and Biomarkers CAR-T cell therapy research Immune Cell Function and InteractionMedicineAdverse effectMelanomaCancerInternal medicineLung cancerImmune systemProstate cancerGastroenterologyAntibody

MeSH terms

NivolumabAdultAntibodies, MonoclonalAntineoplastic AgentsCarcinoma, Non-Small-Cell LungCarcinoma, Renal CellDose-Response Relationship, DrugFemaleHumansLigandsMaleMelanomaNeoplasmsProstatic NeoplasmsColorectal Neoplasms