IP Library › Granted Patent US 12,668,635
Granted Patent B1
US 12,668,635 · App. 18/047,617 · Granted Jun 30, 2026

Methods of treating solid tumors using an anti-PD-1 antibody or a fragment thereof

Inventor: Joyson J. Karakunnel (Potomac, MD)
Assignee: Arcus Biosciences, Inc.
C07K16/2827A61K9/0019A61P35/00C07K2317/565
View Patent ↗
Loading inventors, assignments & file history…
Monitor This Case
Get email alerts when status or documents change.
Order Certified Copies
Most orders are placed with the USPTO same day — all within 24 business hours.
Order via The Patent Place →
Pre-filled with this patent's details
Quick Facts
Patent No.
US 12,668,635
App. No.
18/047,617
Granted
Jun 30, 2026
Kind
B1
Abstract

Provided herein are methods of treating solid tumors comprising administering to a subject in need thereof a therapeutically effective amount of the anti-PD-1 antibodies or the antigen-binding fragments thereof described herein.

Claims (18)

1 . A method of treating a solid tumor, comprising administering to a subject in need thereof an antibody or antigen binding fragment thereof in a flat dose of 80 mg to 360 mg once every two weeks intravenously, said antibody or antigen binding fragment thereof comprising a heavy chain variable region comprising SEQ ID NO: 53; a light chain variable region comprising SEQ ID NO: 67; and a human constant region of IgG4 isotype.

2 . The method of claim 1 , wherein said antibody or antigen binding fragment thereof is administered in a flat dose of 240 mg once every two weeks.

3 . The method of claim 1 , wherein said antibody or antigen binding fragment thereof is administered in a flat dose of 360 mg once every two weeks.

4 . The method of claim 1 , wherein said intravenous administration occurs over a period of 0.1 to 2 hours.

5 . The method of claim 1 , wherein said intravenous administration occurs over a period of 0.1 to 1 hours.

6 . The method of claim 1 , wherein the solid tumor is selected from the group consisting of non-small-cell lung cancer, gastric carcinoma, squamous cell carcinoma of the head and neck, renal cell carcinoma, esophageal cancer, breast cancer, colorectal cancer, prostate cancer, melanoma, bladder cancer, ovarian cancer, endometrial cancer, Merkel cell carcinoma, and gastroesophageal cancer.

7 . A method of treating a solid tumor, comprising administering to a subject in need thereof an antibody or antigen binding fragment thereof comprising a heavy chain variable region comprising SEQ ID NO: 53; a light chain variable region comprising SEQ ID NO: 67; and a human constant region of IgG4 isotype, wherein said antibody or antigen binding fragment thereof is administered intravenously in a flat dose of 240 mg once every two weeks, 360 mg once every three weeks, or is 480 mg once every four weeks.

8 . The method of claim 7 , wherein said antibody or antigen binding fragment thereof is administered intravenously in a flat dose of 240 mg once every two weeks.

9 . The method of claim 7 , wherein said antibody or antigen binding fragment thereof is administered intravenously in a flat dose of 360 mg once every three weeks.

10 . The method of claim 7 , wherein said antibody or antigen binding fragment thereof is administered intravenously in a flat dose of 480 mg once every four weeks.

11 . The method of claim 7 , wherein said intravenous administration occurs over a period of 0.1 to 2 hours.

12 . The method of claim 7 , wherein said intravenous administration occurs over a period of 0.1 to 1 hours.

13 . The method of claim 7 , wherein the solid tumor is an advanced solid tumor.

14 . The method of claim 7 , wherein the solid tumor is selected from the group consisting of non-small-cell lung cancer, gastric carcinoma, squamous cell carcinoma of the head and neck, renal cell carcinoma, esophageal cancer, breast cancer, colorectal cancer, prostate cancer, melanoma, bladder cancer, ovarian cancer, endometrial cancer, Merkel cell carcinoma, and gastroesophageal cancer.

15 . The method of claim 7 , wherein the solid tumor is non-small cell lung cancer, gastric carcinoma, esophageal cancer, gastroesophageal cancer, or squamous cell carcinoma of the head and neck.

16 . The method of claim 7 , wherein the solid tumor is squamous cell carcinoma of the head and neck or ovarian cancer.

17 . The method of claim 1 , wherein the solid tumor is non-small cell lung cancer, gastric carcinoma, esophageal cancer, gastroesophageal cancer, or squamous cell carcinoma of the head and neck.

18 . The method of claim 1 , wherein the solid tumor is squamous cell carcinoma of the head and neck or ovarian cancer.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 8, 2026
From: KARAKUNNEL, JOYSON J.
To: ARCUS BIOSCIENCES, INC.
Reel/Frame 074312/0700 →
Continuity (4)
Continuation 17692482 · Mar 11, 2022
Continuation 17377663 · Jul 16, 2021
Continuation 16197134 · Nov 20, 2018
Provisional Application 62589501 · Nov 21, 2017
References Cited (216)
US RE30985E · Cartaya · 1982 [cited by applicant]
US 4560655A · Baker · 1985 [cited by applicant]
US 4657866A · Kumar · 1987 [cited by applicant]
US 4767704A · Cleveland et al. · 1988 [cited by applicant]
US 4927762A · Darfler · 1990 [cited by applicant]
US 5122469A · Mather et al. · 1992 [cited by applicant]
US 6005079A · Casterman et al. · 1999 [cited by applicant]
US 7595048B2 · Honjo et al. · 2009 [cited by applicant]
US 7638492B2 · Wood et al. · 2009 [cited by applicant]
US 7851598B2 · Davis · 2010 [cited by applicant]
US 7892540B2 · Chen et al. · 2011 [cited by applicant]
US 7943743B2 · Korman et al. · 2011 [cited by applicant]
US 8008449B2 · Korman et al. · 2011 [cited by applicant]
US 8168179B2 · Honjo et al. · 2012 [cited by applicant]
US 8354509B2 · Carven et al. · 2013 [cited by applicant]
US 8460886B2 · Shibayama et al. · 2013 [cited by applicant]
US 8728474B2 · Honjo et al. · 2014 [cited by applicant]
US 8747833B2 · Chen et al. · 2014 [cited by applicant]
US 8779105B2 · Korman et al. · 2014 [cited by applicant]
US 8907157B2 · Buelow · 2014 [cited by applicant]
US 8945561B2 · Davis · 2015 [cited by applicant]
US 8952136B2 · Carven et al. · 2015 [cited by applicant]
US 9067999B1 · Honjo et al. · 2015 [cited by applicant]
US 9073994B2 · Honjo et al. · 2015 [cited by applicant]
US 9084776B2 · Korman et al. · 2015 [cited by applicant]
US 9358289B2 · Korman et al. · 2016 [cited by applicant]
US 9387247B2 · Korman et al. · 2016 [cited by applicant]
US 9393301B2 · Honjo et al. · 2016 [cited by applicant]
US 9402899B2 · Honjo et al. · 2016 [cited by applicant]
US 9439962B2 · Honjo et al. · 2016 [cited by applicant]
US 9492539B2 · Korman et al. · 2016 [cited by applicant]
US 9492540B2 · Korman et al. · 2016 [cited by applicant]
US 9803015B2 · Chen et al. · 2017 [cited by applicant]
US 9856320B2 · Cogswell et al. · 2018 [cited by applicant]
US 10087251B2 · Hermans et al. · 2018 [cited by applicant]
US 10323093B2 · Cogswell et al. · 2019 [cited by applicant]
US 10441655B2 · Korman et al. · 2019 [cited by applicant]
US 10512689B2 · Sadineni et al. · 2019 [cited by applicant]
US 10544224B2 · Manekas et al. · 2020 [cited by applicant]
US 10604575B2 · Cogswell et al. · 2020 [cited by applicant]
US 11008391B2 · Zheng et al. · 2021 [cited by applicant]
US 11643465B2 · Zheng et al. · 2023 [cited by applicant]
US 20140212422A1 · Korman et al. · 2014 [cited by applicant]
US 20150203579A1 · Papadopoulos et al. · 2015 [cited by applicant]
US 20160304607A1 · Sadineni et al. · 2016 [cited by applicant]
US 20170037132A1 · Manekas et al. · 2017 [cited by applicant]
US 20170158776A1 · Feltquate et al. · 2017 [cited by applicant]
US 20180155429A1 · Finckenstein · 2018 [cited by applicant]
US 20180162942A1 · Simon et al. · 2018 [cited by applicant]
US 20180244781A1 · Cuillerot et al. · 2018 [cited by applicant]
US 20180346569A1 · Wang et al. · 2018 [cited by applicant]
US 20190112377A1 · Cogswell et al. · 2019 [cited by applicant]
US 20190144542A1 · Galler et al. · 2019 [cited by applicant]
US 20190194328A1 · Yang · 2019 [cited by applicant]
US 20190263923A1 · Jure-kunkel et al. · 2019 [cited by applicant]
US 20190367616A1 · Lantto et al. · 2019 [cited by applicant]
US 20200002420A1 · Zheng et al. · 2020 [cited by applicant]
US 20200010549A1 · Yang et al. · 2020 [cited by applicant]
US 20200010550A1 · Rietschel et al. · 2020 [cited by applicant]
CN 101213297 · 2008 [cited by applicant]
CN 101526890 · 2009 [cited by applicant]
CN 101763842 · 2010 [cited by applicant]
CN 102131828 · 2011 [cited by applicant]
CN 102737616 · 2012 [cited by applicant]
CN 103242448 · 2013 [cited by applicant]
CN 103701643 · 2014 [cited by applicant]
CN 105336289 · 2016 [cited by applicant]
CN 205017477 · 2016 [cited by applicant]
CN 103608040 · 2017 [cited by applicant]
CN 104250302 · 2017 [cited by applicant]
CN 104479018 · 2018 [cited by applicant]
CN 104479020 · 2019 [cited by applicant]
EP 0402226 · 1990 [cited by applicant]
EP 0404097 · 1990 [cited by applicant]
EP 0183070 · 1991 [cited by applicant]
EP 0244234 · 2001 [cited by applicant]
EP 2152880 · 2011 [cited by applicant]
EP 2360254 · 2011 [cited by applicant]
EP 2336329 · 2012 [cited by applicant]
EP 2857420 · 2015 [cited by applicant]
EP 1810026 · 2018 [cited by applicant]
JP 2006521783 · 2006 [cited by applicant]
JP 2009155338 · 2009 [cited by applicant]
JP 2010500872 · 2010 [cited by applicant]
WO WO8700195 · 1987 [cited by applicant]
WO WO9003430 · 1990 [cited by applicant]
WO WO9311161 · 1993 [cited by applicant]
WO WO9404678 · 1994 [cited by applicant]
WO WO9425591 · 1994 [cited by applicant]
WO WO0114557 · 2001 [cited by applicant]
WO WO2004004771 · 2004 [cited by applicant]
WO WO2004056875 · 2004 [cited by applicant]
WO WO2005066867 · 2005 [cited by applicant]
WO WO2006042237 · 2006 [cited by applicant]
WO WO2006121168 · 2006 [cited by applicant]
WO WO2006133396 · 2006 [cited by applicant]
WO WO2008007144 · 2008 [cited by applicant]
WO WO2008071447 · 2008 [cited by applicant]
WO WO2008112003 · 2008 [cited by applicant]
WO WO2008156712 · 2008 [cited by applicant]
WO WO2010001617 · 2010 [cited by applicant]
WO WO2010063011 · 2010 [cited by applicant]
WO WO2012056407 · 2012 [cited by applicant]
WO WO2013059524 · 2013 [cited by applicant]
WO WO2013168327 · 2013 [cited by applicant]
WO WO2013173223 · 2013 [cited by applicant]
WO WO2014194302 · 2014 [cited by applicant]
WO WO2015134605 · 2015 [cited by applicant]
WO WO2015176033 · 2015 [cited by applicant]
WO WO2016007235 · 2016 [cited by applicant]
WO WO2016100561 · 2016 [cited by applicant]
WO WO2016137985 · 2016 [cited by applicant]
WO WO2016144673 · 2016 [cited by applicant]
WO WO2016168716 · 2016 [cited by applicant]
WO WO2016176503 · 2016 [cited by applicant]
WO WO2016176504 · 2016 [cited by applicant]
WO WO2016191751 · 2016 [cited by applicant]
WO WO2016196389 · 2016 [cited by applicant]
WO WO2017011666 · 2017 [cited by applicant]
WO WO2017019896 · 2017 [cited by applicant]
WO WO2017025051 · 2017 [cited by applicant]
WO WO2017055547 · 2017 [cited by applicant]
WO WO2017087599 · 2017 [cited by applicant]
WO WO2017132508 · 2017 [cited by applicant]
WO WO2017176925 · 2017 [cited by applicant]
WO WO2017210453 · 2017 [cited by applicant]
WO WO2017210624 · 2017 [cited by applicant]
WO WO2017210637 · 2017 [cited by applicant]
WO WO2018053709 · 2018 [cited by applicant]
WO WO2018081621 · 2018 [cited by applicant]
WO WO2018091661 · 2018 [cited by applicant]
WO WO2018132287 · 2018 [cited by applicant]
WO WO2018156494 · 2018 [cited by applicant]
WO WO2018183928 · 2018 [cited by applicant]
WO WO2018204368 · 2018 [cited by applicant]
WO WO2018223040 · 2018 [cited by applicant]
WO WO2019023624 · 2019 [cited by applicant]
WO WO2019062642 · 2019 [cited by applicant]
WO WO2019075468 · 2019 [cited by applicant]
WO WO2019080872 · 2019 [cited by applicant]
Adderson et al., NCBI GenBank database, Accession No. AAA59031.1 immunoglobulin lambda-chain, partial [ [cited by applicant]
Al-Lazikani et al., “Standard conformations for the canonical structures of immunoglobulins,” J. Mol. Biol., 1997, 273(4):927-948. [cited by applicant]
Altschul et al, “Basic local alignment search tool,” J. Mol. Biol., 1990, 215:403-410. [cited by applicant]
Altschul et al., “Gapped BLAST and PSI-BLAST: a new generation of protein database search programs,” Nucleic Acids Res, 1997, 25:3389-3402. [cited by applicant]
Barnes et al., “Methods for growth of cultured cells in serum-free medium,” Anal. Biochem., 1980, 102:255-270. [cited by applicant]
Bendig, “Humanization of rodent monoclonal antibodies by CDR grafting”, Methods: A Companion to Methods in Enzymology, 1995, 8:83-93. [cited by applicant]
Cappelli et al., “Inflammatory arthritis and sicca syndrome induced by nivolumab and ipilimumab”, Ann Rheum Disease, 2016, 0:1-8. [cited by applicant]
Carter et al., “High level [cited by applicant]
Chen et al, “Enhancement and destruction of antibody function by somatic mutation: unequal occurrence is controlled by V gene combinatorial associations”, The EMBO Journal, 1995, 14(12):2784-2794. [cited by applicant]
Chien et al., “Significant structural and functional change of an antigen-binding site by a distant amino acid substitution: Proposal of a structural mechanism”, Proc. Natl. Acad. Sci, Jul. 1989, 86:5532-5536. [cited by applicant]
Chothia et al., “Canonical structures for the hypervariable regions of immunoglobulins,” J.Mol.Biol., 1987, 196(4):901-917. [cited by applicant]
Chothia et al., “Conformations of immunoglobulin hypervariable regions,”Nature., 1989, Dec. 21, 28;342(6252):877-883. [cited by applicant]
Chothia et al., “Domain association in immunoglobulin molecules. The packing of variable domains,” J Mol Biol., 1985, 186(3):651-663. [cited by applicant]
Dahan et al., “TCR-like antibodies distinguish conformational and functional differences in two versus four-domain auto reactive MHC class II-peptide complexes,” Eur J Immunol., 2011, 41:1465-1479, Author Manuscript, 26… [cited by applicant]
Extended European Search Report mailed on Feb. 28, 2019, for EP Patent Application No. 16834675.7, 16 pages. [cited by applicant]
Flisikowska et al., “Efficient immunoglobulin gene disruption and targeted replacement in rabbit using zinc finger nucleases,” PLoS One, 2011, 6:e21045, 10 pages. [cited by applicant]
Freeman 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, 192:1027-1034. [cited by applicant]
GenBank Accession No. AEZ52328.1, “Immunoglobulin alpha heavy chain variable region, partial[ [cited by applicant]
Geurts et al., “Knockout Rats via Embryo Microinjection of Zinc-Finger Nucleases”, Science, 2009, 325(5939):433. 1 page. [cited by applicant]
Geurts et al., “Knockout Rats Produced Using Designed Zinc Finger Nucleases”, Author Manuscript, Science, 2009, 325(5939):433. 3 pages. [cited by applicant]
Graham et al., “Characteristics of a human cell line transformed by DNA from human adenovirus type 5,” J. Gen Virol., 1977, 36:59-72. [cited by applicant]
Griffiths et al., “Human anti-self antibodies with high specificity from phage display libraries”, The EMBO Journal, 1993, 12(2):725-734. [cited by applicant]
Guss et al., “Structure of the IgG-binding regions of streptococcal protein G,” EMBO J., 1986, 5:1567-1575. [cited by applicant]
Ham et al., “Media and growth requirements,” Methods in Enzymology, 1979, 58:44-93. [cited by applicant]
Hamers-Casterrnan et al., “Naturally occurring antibodies devoid of light chains,” Nature, 1993, 363(6428):446-448. [cited by applicant]
Hao et al., “Epitope characterization of an anti-PD-L1 antibody using orthogonal approaches,” Molecular Recognition, 2015, 28:269-276. [cited by applicant]
Higgins et al., “[22] Using CLUSTAL for multiple sequence alignments”, Methods in Enzymology, 1996, 266:383-402. [cited by applicant]
Holliger et al., “Diabodies”: small bivalent and bispecific antibody fragments, Proc Natl Acad Sci USA, 1993, 90(14):6444-6448. [cited by applicant]
Huston et al., “Protein engineering of antibody binding sites: recovery of specific activity in an anti-digoxin single-chain Fv analogue produced in [cited by applicant]
Ignatovich et al., NCBI GenBank database, Accession No. AAF20468.1, immunoglobulin lambda light chain variable region, partial [ [cited by applicant]
Ignatovich et al., NCBI GenBank database, Accession No. AAF20469.1, immunoglobulin lambda light chain variable region, partial [ [cited by applicant]
International Preliminary Report on Patentability for International Application No. PCT/CN2016/094624 dated Feb. 13, 2018. 6 pages. [cited by applicant]
International Search Report and Written Opinion for International Application No. PCT/CN2016/094624 dated Nov. 3, 2016. 13 pages. [cited by applicant]
Ishida et al., “Production of human monoclonal and polyclonal antibodies in TransChromo animals,” Cloning and Stem Cells, 2002, 4:91-102. [cited by applicant]
Koch-Nolte et al., “Single domain antibodies from llama effectively and specifically block T cell ecto-ADP-ribosyltransferase ART2.2 in vivo,” FASEB J., 2007, 21(13):3490-3498. [cited by applicant]
Kussie et al., “A Single Engineered Amino Acid Substitution Changes Antibody Fine Specificity”, Journal of Immunology, 1994, 152:146-152. [cited by applicant]
Larkin et al, “Clustal Wand Clustal X version 2.0,” Bioinformatics, 2007, 23(21):2947-2948. [cited by applicant]
Lee et al., “Complete humanization of the mouse immunoglobulin loci enables efficient therapeutic antibody discovery,” Nat Biotechnol, 2014, 12 pages. [cited by applicant]
Lindmark et al., “Binding of immunoglobulins to protein A and immunoglobulin levels in mammalian sera,” J. Immunol. Meth., 1983, 62:1-13. [cited by applicant]
Lonberg et al., “Antigen-specific human antibodies from mice comprising four distinct genetic modifications,” Nature, 1994, 368(6474): 856-859. [cited by applicant]
Ma et al., “Human antibody expression in transgenic rats: comparison of chimeric IgH loci with human VH, D and JH but bearing different rat C-gene regions,” Journal of Immunological Methods, 2013, 400-401:78-86. [cited by applicant]
Mather et a., “Culture of testicular cells in hormone-supplemented serum-free medium,” Annals NY. Acad. Sci., 1982, 383:44-68. [cited by applicant]
Mather, “Establishment and characterization of two distinct mouse testicular epithelial cell lines,” Biol. Reprod., 1980, 23:243-252. [cited by applicant]
McDermott et al., “PD-1 as a potential target in cancer therapy”, Cancer Medicine, 2013, 2(5):662-673. [cited by applicant]
Mendez et al., “Functional transplant of megabase human immunoglobulin loci recapitulates human antibody response in mice,” Nat Genet., 1997, 15:146-156. [cited by applicant]
Murphy et al., “Mice with megabase humanization of their immunoglobulin genes generate antibodies as efficiently as normal mice,” Proc Natl Acad Sci USA, 2014, 111:5153-5158. [cited by applicant]
Muyldermans et al., “Single domain camel antibodies: current status,” J. Biotechnol., 2001, 74(4):277-302. [cited by applicant]
NCBI accession No. N, P 054862.1, “Programmed cell death 1 ligand 1 isoform a precursor [ [cited by applicant]
NCBI accession No. NM_005018.2, “Programmed cell death 1 ligand 1 isoform a precursor [ [cited by applicant]
NCBI accession No. NM_014143.3, “ [cited by applicant]
NCBI accession No. NP_ 005009.2, “Programmed cell death protein 1 precursor [ [cited by applicant]
Nguyen et al. “Heavy-chain antibodies in Camelidae; a case of evolutionary innovation,” Immunogenetics 2002, 54(1):39-47. [cited by applicant]
Nguyen et al., “Heavy-chain only antibodies derived from dromedary are secreted and displayed by mouse B cells,” Immunology, 2003, 109(1):93-101. [cited by applicant]
Osborn et al., “High-affinity IgG antibodies develop naturally in Ig-knockout rats carrying germline human IgH/Igκ/Igλ loci bearing the rat C [cited by applicant]
Pal et al., NCBI GenBank database, Accession No. AA047766.1, immunoglobulin lambda light chain VLJ region, partial [ [cited by applicant]
Partial Supplementary European Search Report mailed on Dec. 11, 2018, for EP Patent Application No. 16834675.7, 15 pages. [cited by applicant]
Paul, Fundamental Immunology, 3rd Edition, 1993, pp. 292-295. [cited by applicant]
PCT International Preliminary Report on Patentability in International Application No. PCT/CN2015/086594, dated Feb. 13, 2018, 9 pages. [cited by applicant]
PCT International Search Report and Written Opinion in International Application No. PCT/CN2015/086594, dated May 18, 2016, 15 pages. [cited by applicant]
Perez De La Lastra et al., “Epitope mapping of 10 monoclonal antibodies against the pig analogue of human membrane cofactor protein (MCP),” Immunology, Apr. 1999, 96(4 ):663-670. [cited by applicant]
Riechmann et al., “Single domain antibodies: comparison of camel VH and camelised human VH domains,” J Immunol Methods., 1999, 231(1-2):25-38. [cited by applicant]
Rudikoff et al., “Single amino acid substitution altering antigen-binding specificity”, PNAS, 1982, 79:1979-1983. [cited by applicant]
Topalian et al., “Safety, Activity, and Immune Correlations of Anti-PD-1 Antibody in Cancer”, The New England Journal of Medicine, 2012, 366(26):2443-2454. [cited by applicant]
Urlaub et al., “Isolation of Chinese hamster cell mutants deficient in dihydrofolate reductase activity,” Proc. Natl. Acad. Sci. USA, 1980, 77:4216-4220. [cited by applicant]
Agata et al., Expression of the PD-1 antigen on the surface of stimulated mouse T and B lymphocytes, International Immunology, 1996, vol. 8, No. 5, pp. 765-772. [cited by applicant]
Bavencio (avelumab) injection, for intravenous use, New York, NY: EMD Serono, Inc and Pfizer, Inc.; May 2017. [cited by applicant]
Bennett et al., Program Death-1 Engagement Upon TCR Activation has Distinct Effects on Costimulation and Cytokine-driven Proliferation: Attenuation of ICOS, IL-4, and IL-21, But Not CD28, IL-7, and IL-15 Responses, Jour… [cited by applicant]
Blank et al. Interaction of PD-L1 on tumor cells with PD-1 on tumor specific T cells as a mechanism of immune evasion: implications for tumor immunotherapy, Cancer Immunology Immunother, 2005, 54:307-14. [cited by applicant]
Carter et al., PD-1: Pd-L inhibitory pathway affects both CD4+ and CD8+ T cells and is overcome by IL-2, Eur J Immunol, 2002, 32:634-43. [cited by applicant]
Dong et al., Tumor-associated B7-H1 promotes T-cell apoptosis: A potential mechanism of immune evasion, Nature Medicine, Aug. 2002, 8:793-800. [cited by applicant]
Dong et al., B7-H1 pathway and its role in the evasion of tumor immunity, J Mol Med (Berl), 2003, 81:281-287. [cited by applicant]
Eisenhauer et al., New response evaluation criteria in solid tumors: Revised RECIST guidelines (version 1.1), European Journal of Cancer, 2009, 45:228-247. [cited by applicant]
Food and Drug Administration (FDA), Modification of the Dosage Regimen for Nivolumab, Sep. 13, 2016. Available at https://www.fda.gov/drugs/informationondrugs/approveddrugs/ucm520871.htm. [cited by applicant]
Freeman 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., Oct. 2, 2000, vol. 192, No. 7, pp. 1027-1034. [cited by applicant]
Imfinzi (durvalaumab) injection, for intravenous use, Wilmington, DE: AstraZeneca Pharmaceuticals LP; Apr. 2017. [cited by applicant]
Keytruda (pembrolizumab) for injection for intraveous use, Whitehouse Station, NJ: Merck Sharpe & Dohme Corp., a subsidiary of Merck & Co, Inc. May 2014. [cited by applicant]