US 9220776B2
· Sharma
· 2015
[cited by third party]
US 20170313775A1
· Diaz
· 2017
[cited by third party]
JP 2017530950A
· 2017
[cited by applicant]
MX 2019002946A
· 2019
[cited by applicant]
MX 2019008207A
· 2019
[cited by applicant]
WO 2008156712A1
· 2008
[cited by applicant]
WO 2012135408A1
· 2012
[cited by applicant]
WO 2014100079A1
· 2014
[cited by applicant]
WO 2015095423A2
· 2015
[cited by applicant]
WO 2016032927A1
· 2016
[cited by applicant]
WO 2016137850A1
· 2016
[cited by applicant]
WO 2016176504A1
· 2016
[cited by third party]
WO 2016196389A1
· 2016
[cited by applicant]
WO 2017106656A1
· 2017
[cited by applicant]
WO 2017127811A1
· 2017
[cited by third party]
WO 2017151502A1
· 2017
[cited by applicant]
WO WO2017165125A1
· 2017
[cited by examiner]
WO 2017205216A1
· 2017
[cited by third party]
WO 2017197263A1
· 2017
[cited by applicant]
WO 2017210624A1
· 2017
[cited by third party]
WO 2018053106A1
· 2018
[cited by applicant]
WO 2018129559A1
· 2018
[cited by applicant]
Ahmadzadeh et al., Tumor antigen-specific CD8 T cells infiltrating the tumor express high levels of PD-1 and are functionally impaired, Blood, 2009, 1537-1544, 114.
[cited by applicant]
Baert et al., Influence of Immunogenicity on the long term efficacy of Infliximab in Crohns disease, New England Journal Med., 2003, pp. 601-608, 348.
[cited by applicant]
Beniaminovitz et al., Prevention of rejection in cardiac transplantation by blockade of the interleukin 2 receptor with a monoclonal antibody, New England Journal of Medicine, 2000, pp. 613-619, 342.
[cited by applicant]
Brahmer et al., Safety and Activity of Anti-PD-L1 Antibody in Patients with Advanced Cancer, the New England Journal of Medicine, 2012, pp. 2455-2465, vol. 366, No. 26.
[cited by applicant]
Chen et al., PD-L1 Expression is Characteristic of a Subset of Aggressive B-cell Lymphomas and Virus-Associated Malignancies, Clinical Cancer Research, 2013, pp. 3462-3473, vol. 19.
[cited by applicant]
Dang, T.O. et al., Pembrolizumab for the treatment of PD-LI positive advanced or metastatic non-small cell lung cancer, Expert Review of Anticancer Therapy, 2015, 1-23, 11:43.
[cited by applicant]
Dong et al., Tumor-associated B7-H1 promotes T-cell apoptosis: A potential mechanism of immune evasion, Nature Medicine, 2002, pp. 793-800, vol. 8(8).
[cited by applicant]
Freshwater, T. et al., Evaluation of dosing strategy for pembrolizumab for oncology indications, Journal for ImmunoTherapy of Cancer, 2017, 1-9, 5:43.
[cited by applicant]
Gadiot et al., Overall Survival and PD-L1 Expression in Metastasized Malignant Melanoma, Cancer, 2011, 2192-2201, 117.
[cited by applicant]
Gao et al., Overexpression of PD-L1 Significantly Associates with Tumor Aggressiveness and Postoperative Recurrence in Human Hepatocellular Carcinoma, Clinical Cancer Research, 2009, 971-979, 15.
[cited by applicant]
Garon et al., Pembrolizumab for the Treatment of Non-Small-Cell Lung Cancer, the New England Journal of Medicine, 2015, pp. 2018-2028, vol. 372, No. 21.
[cited by applicant]
Ghebeh et al., FOXP3+ Tregs and B7-H1+/PD-1+T lymphocytes co-infiltrate the tumor tissues of high-risk breast cancer patients: Implication for immunotherapy, BMC Cancer, 2008, 57-68, 8.
[cited by applicant]
Ghebeh et al., The B7-H1 (PD-L1) T Lymphocyte-Inhibitory Molecule Is Expressed in Breast Cancer Patients with Infiltrating Ductal Carcinoma: Correlation with Important High-Risk Prognostic Factors, Neoplasia, 2006, 190-…
[cited by applicant]
Ghosh et al., Natalizumab for active Crohns disease, New England J. Med., 2003, pp. 24-32, 348.
[cited by applicant]
Hamanishi et al., Programmed cell death 1 ligand 1 and tumor-infiltrating CD8+ T lymphocytes are prognostic factors of human ovarian cancer, Proceedings of the National Academy of Sciences USA, 2007, 3360-3365, 104.
[cited by applicant]
Hamid et al., Safety and Tumor Responses with Lambrolizumab (Anti-PD-1) in Melanoma, New Eng. J. Med., 2013, 134-144, 369(2).
[cited by applicant]
Hino et al., Tumor cell expression of programmed cell death-1 ligand 1 is a prognostic factor for malignant melanoma, Cancer, 2010, 1757-1766, 116(7).
[cited by applicant]
Inman et al., PD-L1 (B7-H1) expression by urothelial carcinoma of the bladder and BCG-induced granulomata: associations with localized stage progression, Cancer, 2007, 1499-1505, 109.
[cited by applicant]
Lipsky et al., Infliximab and methotrexate in the treatment of rheumatoid arthritis, New England Journal of Medicine, 2000, pp. 1594-1602, 343.
[cited by applicant]
Milgrom et al., Treatment of allergic asthma with monoclonal anti IgE antibody, New England Journal Med., 1999, pp. 1966-1973, 341.
[cited by applicant]
Nakanishi et al., Overexpression of B7-H1 (PD-L1) significantly associates with tumor grade and postoperative prognosis in human urothelial cancers, Cancer Immunol. Immunother., 2007, 1173-1182, 56.
[cited by applicant]
Nomi et al., Clinical Significance and Therapeutic Potential of the Programmed Death-1 Ligand/Programmed Death-1 Pathway in Human Pancreatic Cancer, Clinical Cancer Research, 2007, pp. 2151-2157, vol. 13.
[cited by applicant]
Ohigashi et al., Clinical Significance of Programmed Death-1 Ligand-1 and Programmed Death-1 Ligand-2 Expression in Human Esophageal Cancer, Clin. Cancer Research, 2005, 2947-2953, 11.
[cited by applicant]
Robert et al., Anti-programmed-death-receptor-1 treatment with pembrolizumab in ipilimumab-refractory advanced melanoma: a randomised dose-comparison cohort of a phase 1 trial, the Lancet, 2014, pp. 1109-1117, vol. 384.
[cited by applicant]
Robert et al., Nivolumab in Previously Untreated Melanoma without BRAF Mutation, the New England Journal of Medicine, 2015, pp. 320-330, vol. 372, No. 4.
[cited by applicant]
Robert et al., Pembrolizumab versus Ipilimumab in Advanced Melanoma, the New England Journal of Medicine, Jun. 25, 2015, pp. 2521-2532, 372.
[cited by applicant]
Sharpe et al., The function of programmed cell death 1 and its ligands in regulating autoimmunity and infection, Nature Immunology, 2007, 239-245, 8.
[cited by applicant]
Shimauchi et al., Augmented expression of programmed death-1 in both neoplastic and non-neoplastic CD4+ T-cells in adult T-cell leukemia/lymphoma, Int. J. Cancer, 2007, 2585-2590, 121.
[cited by applicant]
Slamon et al., Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2, New England J. Med., 2001, pp. 783-792, 344.
[cited by applicant]
Taube, et al., Colocalization of inflammatory response with B7-H1 expression in humna melanocytic lesions supports an adaptive resistance mechanism of ummune escape, Sci Transl Med, 2012, pp. 127ra37, vol. 4.
[cited by applicant]
Thompson et al., Costimulatory B7-H1 in renal cell carcinoma patients: Indicator of tumor aggressiveness and potential therapeutic target, Proc. Nat'l Acad. Sci. USA, 2004, 17174-17179, 101(49).
[cited by applicant]
Thompson et al., PD-1 Is Expressed by Tumor-Infiltrating Immune Cells and Is Associated with Poor Outcome for Patients with Renal Cell Carcinoma, Clinical Cancer Research, 2007, pp. 1757-1761, vol. 15.
[cited by applicant]
Thompson et al., Significance of B7-H1 Overexpression in Kidney Cancer, Cancer, 2006, 206-211, 5.
[cited by applicant]
Thompson et al., Tumor B7-H1 Is Associated with Poor Prognosis in Renal Cell Carcinoma Patients with Long-Term Follow-up, Cancer Res., 2006, pp. 3381-3385, vol. 66.
[cited by applicant]
Topalian et al., Safety, Activity, and Immune Correlates of Anti-PD-1 Antibody in Cancer, New Eng. J. Med., 2012, 2443-2454, 366(26).
[cited by applicant]
Topalian et al., Survival, Durable Tumor Remission, and Long-Term Safety in Patients With Advanced Melanoma Receiving Nivolumab, Clinical Journal of Oncology, 2014, pp. 1020-1030, vol. 32, No. 10.
[cited by applicant]
Weber, Wolfgang A., Assessing Tumor Response to Therapy, Journal of Nuclear Medicine, 2009, 1S-10S, 50.
[cited by applicant]
WHO Drug Information, vol. 27, No. 2, pp. 161-162 (2013).
[cited by applicant]
Wolchok et al., Nivolumab plus Ipilimumab in Advanced Melanoma, the New England Journal of Medicine, 2013, pp. 122-133, vol. 369(2).
[cited by applicant]
Yang et al., PD-L1: PD-1 Interaction Contributes to the Functional Suppression of T-Cell Responses to Human Uveal Melanoma Cells In Vitro, Invest Ophthalmol Vis Sci, 2008, 2518-2525, 49(6).
[cited by applicant]
Zhao et al., A Model-Based Exposure-Response (E-R) Assessment of a Nivolumab (NIVO) 4-Weekly (Q4W), AACR, 2017.
[cited by applicant]
Zhao, X. et al., Abstract CT101: A model-based exposure-response (E-R) assessment of a nivolumab (NIVO) 4-weekly (Q4W) dosing schedule across multiple tumor types, AACR, 2017, 1-4, N/A.
[cited by applicant]
Castellino, Alexander M., Pembrolizumab Flat Dosing Wastes Nearly $1 Billion Annually, Medscape Medical NewsConference NewsAmerican Society of Clinical Oncology (ASCO) 2017 Annual Meeting, 2017, 1-3, N/A.
[cited by applicant]
Elassaiss-Schaap, J. et al., Using Model-Based “Learn and Confirm” to Reveal the Pharmacokinetics-Pharmacodynamics Relationship of Pembrolizumab in the Keynote-001 Trial : Modeling of the PK/PD of Pembro in Keynote-001,…
[cited by applicant]
Goldstein, Daniel A. et al., A phamacoeconomic analysis of personalized dosing versus fixed dosing of pembrolizumab in first-line PD-LI positive non-small cell lung cancer, Journal of Clinical Oncology, 2017, Abstract 9…
[cited by applicant]
Lala, Mallika et al., A six-weekly dosing schedule for pembrolizumab in patients with cancer based on evaluation using modelling and simulation, European Journal of Cancer, 2020, 68-75, 131.
[cited by applicant]
Walker, Scott et al., Dosing and Timing of Immuno-Oncology Drugs, CADTH Technology Review: Optimal Use 360 Report, 2019, 1-50, 25.
[cited by applicant]
Ott, Patrick A. et al., Safety and Antitumor Activity of Pembrolizumab in Advanced Programmed Death Ligand 1-Positive Endometrial Cancer: Results From the Keynote-028 Study, J Clin Oncol, 2017, 2535-2541, 35(22).
[cited by applicant]
Pembrolizumab (Rx). Medscape. Sep. 18, 2017. found on Aug. 30, 2022, URL: https://web.archive.org/web/20170918010806/http://reference.medscape.com/drug/keytruda-pembrolizumab-999962 (5 pages).
[cited by applicant]
Kwok, Gerry et al., Pembrolizumab (Keytruda), Human Vaccines & Immunotherapeutics, 2016, 2777-2789, 12:11.
[cited by applicant]
Cooper, L J et al., Role of heavy chain constant domains in antibody-antigen interaction. Apparent specificity differences among streptococcal IgG antibodies expressing identical variable domains, J Immunol, 150(6), 223…
[cited by applicant]
Liang, Wei-Ching et al., Dramatic activation of an antibody by a single amino acid change in framework, Scientific Reports, 11:22365, 1-9, 2021.
[cited by applicant]
McDermott, et al., PD-1 as a potential target in cancer therapy, Cancer Medicine, pp. 662-673, 2013, WO.
[cited by applicant]
Montano, R.F. et al., Influence of the isotype of the light chain on the properties of IgG, the Journal of Immunology, 168, 224-231, 2002.
[cited by applicant]
A. Baumann, Early Development of Therapeutic Biologics—Pharmacokinetics, Current Drug Metabolism, 7, 15-21, 2006.
[cited by applicant]
Agoram, Balaji M. et al., The role of mechanism-based pharmacokinetic-pharmacodynamic (PK-PD) modelling in translational research of biologics, Drug Discovery Today, 12(23/24), 1018-1024, 2007.
[cited by applicant]
Ahamadi, M. et al., Model-Based Characterization of the Pharmacokinetics of Pembrolizumab: A Humanized Anti-PD-1 Monoclonal Antibody in Advanced Solid Tumor, CPT Pharmacometrics Syst. Pharmacol., 6, 49-57, 2017.
[cited by applicant]
Azanza, J-R et al., Monoclonal antibodies: Pharmacokinetics as a basis for new dosage regimens?, J Oncol Pharm Practice, 0(0), 1-7, 2014.
[cited by applicant]
Bai, Shuang et al., A Guide to Rational Dosing of Monoclonal Antibodies, Clin Pharmacokinet, 51(2), 119-135, 2012.
[cited by applicant]
Baselga, J. et al., Phase I Studies of Anti-Epidermal Growth Factor Receptor Chimeric Antibody C225 Alone and in Combination With Cisplatin, J Clin Oncol, 18, 904-914, 2000.
[cited by applicant]
Baxter, Laurence T. et al., Biodistribution of Monoclonal Antibodies: Scale-up from Mouse to Human Using a Physiologically Based Pharmacokinetic Model, Cancer Research, 55, 4611-4522, 1995.
[cited by applicant]
Bruno, Rene et al., Population pharmacokinetics of trastuzumab in patients With HER2+ metastatic breast cancer, Cancer Chemother Pharmacol, 56, 361-369, 2005.
[cited by applicant]
CADTH, Dosing and Timing of Immuno-Oncology Drugs, CADTH, N/A, 3 pages, 2020.
[cited by applicant]
Cao, Yanguang et al., Second-generation minimal physiologically-based pharmacokinetic model for monoclonal antibodies, J Pharmacokinet Pharmacodyn, 40, 597-607, 2013.
[cited by applicant]
Center for Drug Evaluation and Research, Clinical Pharmacology and Biopharmaceutics Review(s), Center for Drug Evaluation and Research, N/A, 1-43, 2014.
[cited by applicant]
Chatterjee, M. et al., Systematic evaluation of pembrolizumab dosing in patients with advanced non-small-cell lung cancer, Annals of Oncology, 27, 1291-1298, 2015.
[cited by applicant]
Chatterjee, MS et al., Population Pharmacokinetic/Pharmacodynamic Modeling of Tumor Size Dynamics in Pembrolizumab-Treated Advanced Melanoma, CPT Pharmacometrics Syst. Pharmacol., 6, 29-39, 2017.
[cited by applicant]
De Greef, R. et al., Pembrolizumab: Role of Modeling and Simulation in Bringing a Novel Immunotherapy to Patients With Melanoma, CPT Pharmacometrics Syst. Pharmacol., 6, 5-7, 2017.
[cited by applicant]
Dirks, Nathanael L. et al., Population Pharmacokinetics of Therapeutic Monoclonal Antibodies, Clin Pharmacokinet, 49(10), 633-659, 2010.
[cited by applicant]
European Medicines Agency, Guideline on the Clinical Investigation of the Pharmacokinetics of Therapeutic Proteins, European Medicines Agency, CHMP/EWP/89249/2004, 11 pages, 2007.
[cited by applicant]
FDA, Review Memo—Keytruda, FDA, N/A, 19 pages, 2020.
[cited by applicant]
Food and Drug Administration, FDA approves new dosing regimen for pembrolizumab, Food and Drug Administration, N/A, 2 pages, 2020.
[cited by applicant]
Grimwood, Sarah et al., Target site occupancy: Emerging generalizations from clinical and preclinical studies, Pharmacology & Therapeutics, 122, 281-301, 2009.
[cited by applicant]
Hamid, Omid et al., Randomized comparison of two doses of the anti-PD-1 monoclonal antibody MK-3475 for ipilimumab-refractory (IPIR) and IPI-naive (IPI-N) melanoma (MEL), Journal of Clinical Oncology, 32(Suppl15), Abstr…
[cited by applicant]
Hendrikx, Jeroen J.M.A. et al., Fixed Dosing of Monoclonal Antibodies in Oncology, the Oncologist, 22, 1212-1221, 2017.
[cited by applicant]
Herbst, Roy S et al., Pembrolizumab versus docetaxel for previously treated, PD-L1-positive, advanced non-small-cell lung cancer (Keynote-010): a randomised controlled trial, Lancet, 387, 1540-1550, 2016.
[cited by applicant]
Jiunn H. Lin, Pharmacokinetics of Biotech Drugs: Peptides, Proteins and Monoclonal Antibodies, Current Drug Metabolism, 10, 661-691, 2009.
[cited by applicant]
Jones, Hannah M. et al., A Physiologically-Based Pharmacokinetic Model for the Prediction of Monoclonal Antibody Pharmacokinetics From In Vitro Data, CPT Pharmacometrics Syst. Pharmacol., 8, 738-747, 2019.
[cited by applicant]
Keizer, Ron J. et al., Clinical Pharmacokinetics of Therapeutic Monoclonal Antibodies, Clin Pharmacokinet, 49(8), 493-507, 2010.
[cited by applicant]
Kontermann, Roland, Strategies to Extend Plasma Half-Lives of Recombinant Antibodies, Biodrugs, 23(2), 93-109, 2009.
[cited by applicant]
Koren, E. et al., Immune Responses to Therapeutic Proteins in Humans—Clinical Significance, Assessment and Prediction, Current Pharmaceutical Biotechnology, 3, 349-360, 2002.
[cited by applicant]
Lee, Jean W et al., Bioanalysis of target biomarker and PK/PD relevancy during the development of biotherapeutics, Bioanalysis, 4(20), 2513-2523, 2012.
[cited by applicant]
Li, Hongshan et al., Time dependent pharmacokinetics of pembrolizumab in patients with solid tumor and its correlation with best overall response, J Pharmacokinet Pharmacodyn, 44, 403-414, 2017.
[cited by applicant]
Li, Tommy R. et al., Pivotal Dose of Pembrolizumab: A Dose-Finding Strategy for Immuno-Oncology, Clinical Pharmacology & Therapeutics, 110(1), 200-209, 2021.
[cited by applicant]
Lindauer, A et al., Translational Pharmacokinetic/Pharmacodynamic Modeling of Tumor Growth Inhibition Supports Dose-Range Selection of the Anti-PD-1 Antibody Pembrolizumab, CPT Pharmacometrics Syst. Pharmacol., 6, 11-20…
[cited by applicant]
Lobo, Evelyn D. et al., Antibody Pharmacokinetics and Pharmacodynamics, J Pharm Sci, 93(11), 2645-2668, 2004.
[cited by applicant]
Lynch, Carmel M. et al., Practical considerations for nonclinical safety evaluation of therapeutic monoclonal antibodies, mAbs, 1:1, 2-11, 2009.
[cited by applicant]
Marianne J. H. Van Vugt, et al., Immunogenicity of pembrolizumab in patients with advanced tumors, Journal for Immuno Therapy of Cancer, 7:212, 1-8, 2019.
[cited by applicant]
Mould, D. R. et al., Basic Concepts in Population Modeling, Simulation, and Model-Based Drug Development, CPT: Pharmacometrics & Systems Pharmacology, 1:e6, 1-14, 2012.
[cited by applicant]
Mould, Diane R et al., The pharmacokinetics and pharmacodynamics of monoclonal antibodies—mechanistic modeling applied to drug development, Current Opinion in Drug Discovery & Development, 10(1), 84-96, 2007.
[cited by applicant]
Mould, DR et al., Basic Concepts in Population Modeling, Simulation, and Model-Based Drug Development—Part 2: Introduction to Pharmacokinetic Modeling Methods, CPT: Pharmacometrics & Systems Pharmacology, 2(e38), 1-14, …
[cited by applicant]
Newsome, Barrett W. et al., The clinical pharmacology of therapeutic monoclonal antibodies in the treatment of malignancy; have the magic bullets arrived?, Br J Clin Pharmacol, 66:1, 6-19, 2008.
[cited by applicant]
Peletier, Lambertus A. et al., Dynamics of target-mediated drug disposition: characteristic profiles and parameter identification, J Pharmacokinet Pharmacodyn, 39, 429-451, 2012.
[cited by applicant]
Putnam, Wendy S. et al., Pharmacokinetic, pharmacodynamic and immunogenicity comparability assessment strategies for monoclonal antibodies, Trends in Biotechnology, 28(10), 509-516, 2010.
[cited by applicant]
Ribas, Antoni et al., Association of Pembrolizumab With Tumor Response and Survival Among Patients With Advanced Melanoma, JAMA, 315(15), 1600-1609, 2016.
[cited by applicant]
Ribas, Antoni et al., Pembrolizumab versus investigator-choice chemotherapy for ipilimumab-refractory melanoma (Keynote-002): a randomised, controlled, phase 2 trial, Lancet Oncol, 16, 908-918, 2015.
[cited by applicant]
Rippe, B. et al., Fluid and protein fluxes across small and large pores in the microvasculature. Application of two-pore equations, Acta Physiol Scand, 131, 411-428, 1987.
[cited by applicant]
Sachs, Jeffrey R. et al., Optimal Dosing for Targeted Therapies in Oncology: Drug Development Cases Leading by Example, Clin Cancer Res, 22(6), 1318-1324, 2016.
[cited by applicant]
Upton, RN et al., Basic Concepts in Population Modeling, Simulation, and Model-Based Drug Development: Part 3—Introduction to Pharmacodynamic Modeling Methods, CPT Pharmacometrics Syst. Pharmacol., 3(e88), 1-16, 2014.
[cited by applicant]
US Dept of Health & Human Services Food & Drug Admin, Guidance for Industry-Exposure-Response Relationships—Study Design, Data Analysis, and Regulatory, US Dept of Health & Human Services Food & Drug Admin, N/A, 1-28, 2…
[cited by applicant]
Wang, Diane D. et al., Fixed Dosing Versus Body Size-Based Dosing of Monoclonal Antibodies in Adult Clinical Trials, Journal of Clinical Pharmacology, 49, 1012-1024, 2009.
[cited by applicant]
Wang, W. et al., Monoclonal Antibody Pharmacokinetics and Pharmacodynamics, Nature, 84(5), 548-558, 2008.
[cited by applicant]
Vugmeyster, Yulia et al., Biodistribution of [125I]-Labeled Therapeutic Proteins: Application in Protein Drug Development Beyond Oncology, J Pharm Sci, 99(2), 1028-1045, 2010.
[cited by applicant]
Zhu, Hui et al., Tumor Pretargeting for Radioimmunodetection and Radioimmunotherapy, J Nucl Med, 39, 65-76, 1998.
[cited by applicant]
Dang, et al., “Pembrolizumab for the treatment of PD-L1 positive advanced or metastatic non-small cell lung cancer”, Expert Rev Anticancer Ther., vol. 16(1), pp. 13-20, 2016.
[cited by applicant]
Ernstoff, Marc S., “The clinical pharmacology of therapeutic monoclonal antibodies in the treatment of malignancy; have the magic bullets arrived?”, British Journal of Clinical Pharmacology, vol. 6:1, pp. 6-19, May 22, …
[cited by applicant]
Food and Drug Administration, Guidance for Industry Population Pharmacokinetics, CP 1, N/A, 35 pages, 1999.
[cited by applicant]
Glassman, Patrick M., et al., “Physiologically-based modeling to predict the clinical behavior of monoclonal antibodies directed against lymphocyte antigens”, MABS, vol. 9:2, pp. 297-306, 2017.
[cited by applicant]
Hansel, Trevor T., et al., “The safety and side effects of monoclonal antibodies”, Nature Reviews Drug Discovery, vol. 9, pp. 325-338, Apr. 2010.
[cited by applicant]
Jain, Rajul K. et al., “Phase I Oncology Studies: Evidence That in the Era of Targeted Therapies Patients on Lower Doses Do Not Fare Worse”, American Association for Cancer Research., vol. 16(4), pp. 1289-1297, 2010.
[cited by applicant]
Mathijssen, Ron H. J., et al., “Determining the optimal dose in the development of anticancer agents”, Nature Reviews Clinical Oncology, vol. 11, pp. 272-281, May 2014.
[cited by applicant]
Nghiem, Paul T., et al., “PD-1 blockade with pembrolizumab in advanced Merkel-cell carcinoma”, N Engl J Med, 374;26, 2542-2552, 2016.
[cited by applicant]
Ryman, Josiah T., et al., “Pharmacokinetics of Monoclonal Antibodies”, CPT Pharmacometrics Syst. Pharmacol., vol. 6, pp. 576-588, 2017.
[cited by applicant]
Tosi, Diego, et al., “Clinical Development Strategies and Outcomes in First-in-Human Trials of Monoclonal Antibodies”, American Society of Clinical Oncology, vol. 33, pp. 2158-2165, 2015.
[cited by applicant]
Truong, Phu et al., Metastatic Hepatocellular Carcinoma Responsive to Pembrolizumab, Cureus, 8(6): e631, 1-3, 2016.
[cited by applicant]
Wong, et al, “Dose-limiting toxicity and maximum tolerated dose: still fit for purpose?”, thelancet. com, vol. 16, pp. 1287-1288, Oct. 2015.
[cited by applicant]
Zinzani, Pier Luigi et al., Safety and tolerability of pembrolizumab in patients with relapsed/refractory primary mediastinal large B-cell lymphoma, Blood, 130(3), 267-270, 2017.
[cited by applicant]
Bates, Adam et al., David vs. Goliath: The Structure, Function, and Clinical Prospects of Antibody Fragments, Antibodies, 8(2), 1-31, 2019.
[cited by applicant]
Freshwater et al., Evaluation of dosing strategy for pembrolizumab for oncology indications, Journal for ImmunoTherapy of Cancer, vol. 5, Article No. 43 (2017).
[cited by third party]